Advanced Cell Technology

Advanced Cell Technology's Executive Invited to Present Today to FDA Advisory Committee on Cellular Tissue Therapies

2008-04-10T13:23:00Z

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that Jonathan H. Dinsmore Ph.D., Senior Vice President – Regulatory and Clinical, has been invited to present to the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research Advisory Committee on Cellular, Tissue and Gene Therapies. Dr. Dinsmore will deliver a presentation today titled, “Safety Considerations for the Clinical Application of Human Embryonic Stem Cells” to the FDA panel, which will convene at the Hilton Hotel in Gaithersburg, Maryland. The presentation is scheduled for 10 a.m. eastern time. The panel is expected to conduct hearings on Cellular Therapies Derived from Human Embryonic Stem Cells Scientific Considerations for Pre-Clinical Safety Testing. Other companies invited to present include Geron Corporation (NASDAQ: GERN) and Novocell, Inc.

During Dr. Dinsmore’s presentation, he is expected to discuss cell sourcing, manufacturing and delivery of human embryonic stem cells. He will also present certain conclusions from pre-clinical activities surrounding the company’s retinal pigmented epithelial (RPE) cell therapy. Advanced Cell recently completed discussions with the FDA regarding this program through a type B, pre-Investigational New Drug (pre-IND) meeting concerning the regulatory pathway and requirements to file an IND to initiate human clinical trials. The entire presentation will be available on the company’s web site at www.advancedcell.com/conference-presentations after 11 a.m. eastern time today.

“We are honored that the FDA has invited us to participate in this panel, which could be influential in shaping the clinical pathway for the testing of embryonic stem cells,” said William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology, Inc. “As one of the few stem cell companies that is preparing for later-stage clinical trials, we are pleased that we will be able to share our views with FDA executives and other distinguished members of the scientific community on the safety issues surrounding human embryonic stem cell development.”

Additional details on the FDA meeting may be found at www.fda.gov/ohrms/dockets/ac/cber08.html#CellularTissueGene Therapies (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists).

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-QSB for the quarter ended September 30, 2007. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

CEOcast, Inc. for Advanced Cell Technology
Daniel Schustack, 212-732-4300

Source: Business Wire (April 10, 2008 - 9:23 AM EDT)

Advanced Cell Technology Platform Yields Over 140 Cell Types from Human Embryonic Stem Cells

2008-04-03T12:38:00Z

Research Represents a Breakthrough in the Mapping and Characterization of the Cells of Early Human Development; Company to provide differentiated embryonic progenitor cell lines from its ACTCellerate Platform for therapeutic applications, research tools, and drug discovery

Advanced Cell Technology, Inc. (OTCBB: ACTC; www.advancedcell.com) reported today on a large-scale differentiation process that has generated panels of differentiating human progenitor cell lines from human embryonic stem cells (hESCs). The research will be published in the April issue of Regenerative Medicine (Vol. 3[3] e-pub ahead of print) and will be freely available at www.futuremedicine.com/loi/rme.

Since the first isolation of hESCs, scientists and industry alike have been working to harness the power of these cells for the purpose of restoring and regenerating body systems that have been damaged by disease or injury

One of the hurdles has been a commercially viable means for the expansion of sufficient numbers of the cell types needed for tissue regeneration. With the publication of work entitled “The ACTCellerate Initiative: large-scale combinatorial cloning of novel human embryonic stem cell derivatives,” ACT scientists have solved some of these problems. The paper describes a system that was established to isolate and clonally expand tissue specific precursors that heretofore could only be isolated from aborted human fetal tissue.

Dr Chris Mason (UCL), Associate Editor of Regenerative Medicine said, “This is an enormously exciting development for the regen sector. The research reported… represents a quantum leap forward in embryonics, the mapping and characterization of the cells of early human development. Without any doubt, the ACTCellerate technology will greatly hasten the translation of human embryonic stem cell-based therapies into safe and effective products for routine clinical practice.”

The benefits of the ACTCellerate technology transcend therapeutics and extend as well into revolutionary applications for drug discovery, drug toxicity testing, and cancer research. This advance holds great promise for future research and may one day lead to many new cell-based therapies in the emerging field of regenerative medicine.

Another important finding in this publication is that these normal embryonic progenitor cell types show the expression of certain genes (such as oncofetal markers) often associated in the literature with malignant cancer. However, when these progenitor cells were injected into supportive mice, no malignant tumors could be observed. This indicates that expression of such genes is a function of these cells’ normal primitive stage of differentiation and not linked to any disease potential.

William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology, Inc., stated, “We are greatly indebted to Mike West for his insight in initiating this program during his tenure with ACT and to the entire ACT scientific team for their perseverance in bringing this groundbreaking research to the conclusions described in this publication. ACT has taken great strides in identifying both clinical applications for this approach as well as for the ACTCellerate cell line library for drug target discovery, assay development, and direct therapeutics development across a wide spectrum of clinical indications. We are now in a position to offer our refined technology and know-how to potential partners and licensees.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (April 3, 2008 - 8:38 AM EDT)

Barbara Walters' ABC Network Television Special Highlights Role that Advanced Cell Technology's Embryonic Stem Cells Play in Preventing Aging

2008-04-02T11:31:00Z

Program Highlights Accomplishments of Company’s Chief Scientific Officer and Blastomere Program

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that an ABC Television’s special report titled, “Live to 150, Can You Do It? Secrets to Living Longer,” which aired last night and was hosted by Barbara Walters, highlighted the role that the company’s blastomere program for creating human embryonic stem cell (hESC) lines without impacting the developmental potential of embryos could play in extending life and slowing down the aging process. The special also highlighted Advanced Cell Technology’s research into developing a universal O negative red blood cell bank using human embryonic stem cell science. The report, which included an interview with Dr. Robert Lanza, MD, Chief Scientific Officer at Advanced Cell Technology, featured the company’s research platforms and included a discussion of the role that the company’s stem cell science could play in treating various diseases.

The show profiled the lives of several people who are currently 100 years old or older and described some of the most promising scientific developments that could extend life. Advanced Cell Technology’s technology platform was included among the scientific breakthroughs.

In August 2006, Advanced Cell Technology reported in the journal Nature that company scientists had successfully generated hESCs using its blastomere technology, an approach that does not destroy the developmental potential of embryos. The blastomere technology has been reproduced and peer-reviewed on several occasions. In June 2007, ACT announced at the fifth annual meeting of the International Society for Stem Cell Research in Cairns, Australia, that it had reproduced its work by successfully producing an hESC line without destroying an embryo at its lab in Worcester, Massachusetts. In January 2008, ACT together with colleagues announced the development of five hESC lines without the destruction of embryos. The method was published in the journal Cell Stem Cells, published by Cell Press. The peer-reviewed technique was initially carried out by ACT scientists under the direction of Dr. Lanza and then independently replicated by scientists on the West Coast. In addition, the NIH announced in 2007 that it would begin implementing President George W. Bush’s Executive Order to explore methods to expand the number of approved pluripotent stem cell lines “without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.” ACT’s blastomere program was cited by the NIH as an alternative method in its implementation plan; therefore, should the company’s blastomere technique satisfy NIH qualifications, ACT could qualify for federal funding from the NIH.

In addition to its blastomere research platform, Advanced Cell Technology has made progress on the therapeutic front. ACT published positive data in the journal NATURE Methods for its HG (hemangioblast) cell program for the treatment of blood and cardiovascular diseases. The company published positive data from animal studies for its RPE (retinal pigment epithelial) cell program for the treatment of retinal degenerative disorders completed in collaboration with the Casey Eye Institute at Oregon Health and Science University. The company also has GLP Safety Studies in process for its RPE Program. Finally, ACT’s Myoblast program, an autologous adult stem cell therapy for the treatment of heart disease, has successfully completed four Phase I clinical trials and has clearance from the FDA to begin Phase II trials shortly.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (April 2, 2008 - 7:31 AM EDT)

Advanced Cell Technology to be Featured Tonight on ABC Television's Special Report ''Live to 150, Can You Do It? Secrets to Living Longer''

2008-04-01T13:09:00Z

Report Hosted by Barbara Walters to Air Nationally at 10 PM ET

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that the company will be featured on ABC Television’s special report titled, “Live to 150, Can You Do It? Secrets to Living Longer,” hosted by Barbara Walters. The report is scheduled to air tonight on ABC Television throughout the country at 10 PM eastern time. The report will include an interview with Dr. Robert Lanza, MD, Chief Scientific Officer at Advanced Cell Technology. During the interview, Dr. Lanza and Ms. Walters will discuss a number of Advanced Cell Technology’s research platforms including its blastomere program for creating human embryonic stem cell (hESC) lines without impacting the developmental potential of embryos as well as the company’s research into developing a universal O negative red blood cell bank using human embryonic stem cell science.

Additional details on the show can be found at: http://abcnews.go.com/Health/Longevity/story?id=4544003&page=1

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (April 1, 2008 - 9:09 AM EDT)

Advanced Cell Technology Completes Private Placement

2008-03-31T21:33:00Z

Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it completed a private placement with institutional and other accredited investors. The company intends to use the proceeds of the offering towards for general corporate purposes, including additions to working capital, and to finance the further development of the company’s clinical programs.

Advanced Cell Technology closed on the private placement of $3,855,360 principal amount of amortizing senior secured convertible debentures. The issuance of the debentures generated $3,072,000 in gross proceeds.

William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology remarked, “This transaction represents a significant event for Advanced Cell Technology and reflects the growing recognition of the potential of the company’s stem cell technology. The proceeds from this financing will allow ACTC to accelerate its development programs focused on novel therapies for diseases and indications that have few medical alternatives. Cardiovascular disease and regenerative retinal disorders represent substantial unmet medical needs that we believe our cell based therapies address.”

Additional details regarding the financing will be included in a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying stem cell technology in the emerging field of regenerative medicine. The company operates facilities in Alameda, California and Worcester, Massachusetts. For more information about the company, please visit www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-QSB for the quarter ended June 30, 2007.

Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Dan Schustack, 212-732-4300

Source: Business Wire (March 31, 2008 - 5:33 PM EDT)

Advanced Cell Technology Announces Catheter Supply Agreement with Biologics Delivery Systems Group

2008-03-05T12:12:00Z

Agreement Represents Progress Toward Commencing Phase II Human Clinical Trials for Myoblast Therapy

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that it has reached a supply agreement with Biologics Delivery Systems Group, Cordis Corporation (a Johnson & Johnson company), in which Biologics Delivery Systems will supply catheters for the Phase II human clinical trial of ACT’s myoblast therapy for the treatment of heart failure. Advanced Cell Technology’s myoblast therapy successfully completed Phase I human clinical trials in 2007 utilizing the therapy safely in more than forty patients. Safety of the therapy was demonstrated in four independent studies. The U.S. Food and Drug Administration has given the company clearance to proceed with Phase II human clinical trials. The company expects its Phase II human clinical trial (CAuSMIC II) to begin shortly.

ACT’s myoblast therapy involves the transplantation of expanded autologous myoblasts (adult progenitor stem cells) derived from a small biopsy of skeletal muscle from a patient’s leg. The technology allows for the expansion of myoblasts into hundreds of millions of cells over a period of two to three weeks. The resulting myoblasts are then transplanted back into the patient’s scarred heart tissue through the use of a catheter-based procedure. Over one million new patients with heart attacks are treated annually in the United States alone, representing a multi-billion dollar market opportunity. Current therapies do not result in rebuilding of heart muscle and do not prevent progression of congestive heart failure, poor quality of life, and long-term deterioration. According to the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health, approximately 5 million people in the United States have congestive heart failure and an estimated 400,000 new cases are diagnosed each year. Roughly 50% of CHF patients die within 5 years.

The Phase II human clinical trial will be a multi-center study following a similar protocol to the one used in the company’s Phase I study. That study demonstrated safety and evidence of significant heart function improvement in congestive heart failure patients as a result of the implantation of the ACT’s proprietary autologous skeletal myoblasts using the Biologics Delivery Systems NOGA® Cardiac Navigation System and MyoStar® Injection Catheter. “The NOGA® System created highly precise, three-dimensional images of the heart. These images gave us a clear ‘map’ that helped us to successfully deliver the adult stem cells where we intended them to go,” commented Dr. Nabil Dib, the lead investigator for the myoblast phase I study. “This imaging technology was critical to making this study possible.” The Phase II human clinical trial will use the latest generation catheters provided as a result of ACT’s ongoing relationship with the Biologics Delivery Systems.

“The supply commitment for NOGA mapping and Myostar injection catheters from Biologics Delivery Systems Group represents another step toward commercializing our myoblast therapy and bringing novel treatment to patients with few effective alternatives,” commented William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology. “We are excited to commence our Phase II human clinical trials soon.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (March 5, 2008 - 8:12 AM EST)

Advanced Cell Technology, Inc. Enters into License Agreement with Pharming Group N.V.

2008-02-29T11:38:00Z

Company Continues to Leverage IP Portfolio

Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it has entered into an agreement with Pharming Group N.V. giving Pharming an exclusive, global license to non-human use of certain patents associated with but not limited to oocyte activation patents held by Advanced Cell Technology. According to the terms of the license agreement, Pharming will pay Advanced Cell Technology a one-time license fee. Prior, Pharming had a nonexclusive license to these patents. Based in the Netherlands, Pharming Group N.V. is focused on developing treatments for genetic and aging diseases, specialty products for surgical indications, and intermediates for various applications and nutritional products.

Advanced Cell Technology has been focused on building a broad intellectual property portfolio since its inception. In early 2007, the company strengthened its IP portfolio by acquiring the intellectual property assets of its former competitor Infigen, Inc. relating to somatic cell nuclear transfer, parthenogenesis, and other related technologies. Upon the closing of its Mytogen, Inc. acquisition later that year, ACT absorbed Mytogen’s patent portfolio as well. Advanced Cell Technology now owns or has exclusive licenses to over 380 patents and patent applications worldwide in the field of regenerative medicine and stem cell therapy. In addition, ACT has non-exclusive rights to a portfolio of patents and patent applications that support its core intellectual property.

“We are pleased to be able to monetize our intellectual property portfolio in a number of ways,” stated William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology. “Our intellectual property and the research and science that our employees perform remain the foundation of our company. Using this foundation as a basis for developing commercial therapeutics and entering into licensing agreements allows us to finance the company in profitable and nondilutive manners. We plan on continuing to leverage our IP portfolio.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (February 29, 2008 - 7:38 AM EST)

Advanced Cell Technology Demonstrates Efficient Generation of Functional Hepatocytes (Liver Cells) From Human Embryonic Stem Cells

2008-02-21T16:02:00Z

Company Makes Progress on Multiple Therapeutic Fronts

Advanced Cell Technology, Inc. (OTCBB: ACTC) reported today for the first time a robust and highly efficient process for the generation of high-purity hepatocytes (liver cells). The research, described online (ahead of print) in the journal STEM CELLS, signifies a significant step towards the efficient generation of hepatocytes for use in regenerative medicine and drug discovery. Moreover, the research represents another one of Advanced Cell Technology’s efforts aimed at the large-scale differentiation of human embryonic stem cells (hESCs) into critical replacement cell types. In addition to demonstrating the efficient generation of hepatocytes in research published today, the company has made significant progress in the generation of retinal pigmented epithelial (RPE) cells to treat retinal degenerative diseases and the generation of hemangioblasts to treat vascular disease as well as to create a large-scale and donorless source of red blood cells and platelets.

Two hallmarks of embryonic stem cells, their versatility and capacity for unlimited self renewal, suggest the cells could serve as a potentially inexhaustible source of cells for replacement therapy. As with other tissues, there is a scarcity of donor livers and hepatocytes, which is compounded by the low recovery and proliferative capacity of adult hepatocytes. In addition to the cells’ potential use for the treatment of liver disease, hESC-derived hepatocytes could also provide a valuable model for novel pharmaceutical drug discovery assays as well as new drug metabolism and cytotoxicity screens, particularly because the liver is a major site for detoxification.

“We have established a highly-efficient method for deriving hepatocytes from stem cells that mirrors events in embryonic development,” said Robert Lanza, M.D., Chief Scientific Officer at Advanced Cell Technology, Inc. and senior author of the study. “Large scale production of hepatocytes using this method should greatly bolster their applications in basic research, clinical medicine and preclinical drug discovery.”

The method reported yielded synchronous populations of hepatocytes that were generated in clinically preferred conditions with minimum use of serum and cell feeders. Highly enriched populations of definitive endoderm (DE) were generated from hESCs and then induced to differentiate along the hepatic lineage by the sequential addition of inducing factors implicated in physiological hepatogenesis. The differentiation process was largely uniform with cell cultures progressively expressing increasing numbers of hepatic lineage markers. The hepatocytes exhibited functional hepatic characteristics such as glycogen storage, indocyanine green uptake and release, and albumin secretion. In an animal model of acute liver injury, the hESC-DE cells differentiated into hepatocytes and successfully repopulated the damaged liver.

“I am delighted with the tremendous progress our scientists are making to generate a variety of important functional cells types and refine our cell differentiation process,” stated William M. Caldwell IV, CEO and Chairman of Advanced Cell Technology. “These cells have the potential to benefit many Americans suffering from serious and potentially life-threatening diseases with few if any alternatives. We are committed to developing new methods to help translate our stem cell technology into the clinic and are seeking partners for some of our newest scientific advances.”

Other authors on the paper were Dr. Sadhana Agawal (first author of the study) and Katherine Holton, a senior research associate at Advanced Cell Technology, Inc.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (February 21, 2008 - 12:02 PM EST)

Advanced Cell Technology Announces Presentation of Results from Myoblast Study at ISCTR World Symposium

2008-02-11T13:35:00Z

Study Results Demonstrate Long Term Cell Survival and Quality of Life Improvements

Advanced Cell Technology, Inc. (OTCBB: ACTC - News) announced today that principal investigator Dr. Nabil Dib, M.D., M.Sc., FACC, presented results from a 23-patient study of ACT’s myoblast therapy for the treatment of congestive heart failure (CHF) over the weekend at the International Society for Cardiovascular Translational Research (ISCTR) World Symposium in San Diego, CA. Dr. Dib presented the results as a case study of the successful translation of a therapy from scientific research to the bedside. The results of the study demonstrate long term cell survival in heart failure patients as well as strong quality of life improvements as measured by the New York Heart Association third party questionnaire, the Minnesota Living with Heart Failure Questionnaire, and the 6 minute walk results (compared to continued deterioration by the control group). Moreover, ACT’s myoblast trial has been the only cell-based, FDA-approved human clinical trial that has not required the administration of anti-arrhythmic drugs or assist devices, which is in contrast to trials for bone marrow-derived and other adult stem cell therapies.

ISCTR is an annual meeting for basic and clinical scientist practicing cardiovascular disease research sponsored by the University California, San Diego, Catholic Healthcare West and the International Society for Cardiovascular Translational Research. Dr. Dib is Director, Clinical Cardiovascular Cell Therapy, University of California, San Diego, and Director of Cardiovascular Research of Catholic Health Care West’s Chandler Regional Hospital and Mercy Gilbert Medical Center near, Phoenix, Arizona.

Dr. Dib enrolled 23 patients at Arizona Heart Institute with poor heart function and congestive heart failure. The control group consisted of 11 patients on standard drug therapy while the treatment group was given varying doses of 30, 100, 300, or 600 million autologous skeletal myoblast (ASM) cells. After one year, the myoblast therapy showed a favorable safety profile as compared to the control group. Likewise, secondary measures showed improvements in quality of life measures, improvements in measures of tissue regrowth and potential improvement in heart function, while the control group showed signs of heart failure progression on the same measures. The data from the study support conducting larger double-blind, placebo controlled studies. A Phase II human clinical trial has been reviewed and cleared to commence by the FDA. The planned Phase II trial will be conducted at multiple clinical centers across the country including in Arizona and California.

Patients with CHF due to myocardial infarction (damage in heart muscle) often have scar tissue in the heart, which limits the heart’s ability to pump blood. In spite of optimal medical therapy and other current heart failure treatments, in the United States alone 2 million patients per year are admitted to the hospital for CHF and almost one-half million die annually. Doctors may now have the opportunity to successfully replace scarred heart tissue with healthy muscle via intracardiac injections of ASM stem cells from the skeletal muscle.

“In this study, we learned that ASM cell transplantation using a minimally invasive catheter system is safe, showed improvement in measures of quality of life, and may have the potential to improve cardiac function and electrical activity,” said Dr. Dib. By using a catheter and transplanting ASM cells into scarred tissue, new living muscle can potentially be formed with limited risk to the patient. Since the transplanted stem cells are harvested from the patient’s own skeletal muscles, the cells are compatible with the body, avoiding possible immune system and tissue compatibility complications. The procedure poses less risk than surgical procedures because no anesthesia is required and only a small incision is necessary for catheter access. Patients can be discharged within 24 hours of the procedure.

“We are honored that the ISCTR chose our myoblast therapy as the centerpiece for discussing how best to translate research from the bench to the bedside,” stated William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology, Inc. “We remain encouraged by the data Dr. Dib presented and believe the positive 12-month data represent another step in our process of initiating a Phase II human clinical trial for our myoblast therapy. We look forward to moving the myoblast and other stem cell therapies through the clinic and ultimately to patients in need of treatment.” In addition to nearing the commencement of Phase II human clinical trials for the myoblast therapy, ACT recently completed a pre-IND meeting with the FDA for its RPE program for the treatment of retinal degenerative disease. Should ACT successfully file an IND for its RPE therapy, the company plans to move forward with Phase I human clinical trials, which would position ACT with two therapies in human clinical trials as well as a third, the hemangioblast program for the treatment of blood and cardiovascular indications, in preclinical trials.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Chad Griffin Consulting, Inc.
Media:
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300

Source: Business Wire (February 11, 2008 - 9:35 AM EST)

Advanced Cell Technology Announces Completion of Pre-IND Meeting with the FDA for RPE Therapy for the Treatment of Retinal Degenerative Disease

2008-02-01T13:29:00Z

Company Demonstrates Progress Toward Moving its Second Cell Therapy into Human Clinical Trials

Advanced Cell Technology, Inc. (OTCBB:ACTC) today announced that it completed discussions with the Food and Drug Administration (FDA) regarding its retinal pigmented epithelial (RPE) cell therapy through a type B, pre-Investigational New Drug (pre-IND) meeting concerning the regulatory pathway and requirements to file an IND to initiate human clinical trials. ACT is working with the agency to fulfill the FDA’s requirements to bring its RPE cell therapy into human clinical trials for the treatment of retinal degenerative diseases such as Retinitis Pigmentosa, Stargardt’s disease, and dry age-related macular degeneration (AMD). The RPE cells are derived from human embryonic stem cells created from ACT single blastomere cell lines under GMP compliant conditions. ACT is moving forward with its characterized RPE manufacturing process to complete the final stages of the company’s preclinical testing. Should ACT successfully file an IND for its RPE therapy, the company plans to move forward with Phase I human clinical trials. ACT’s Myoblast therapy, an autologous adult stem cell therapy for the treatment of heart failure, has already successfully completed Phase I human clinical trials and is moving into Phase II human clinical trials shortly.

Studies of the company’s proprietary RPE cells have shown that the therapy may ultimately provide effective treatment of degenerative retinal disorders including macular degeneration, which represents a $28 billion dollar market. AMD affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 in the United States. The prevalence of AMD begins to increase after the age of 50. Approximately 15% of people over 75 have the condition. To date, AMD patients have had few if any effective therapies for treatment; thus, the need for novel therapies is clear.

In November at Neuroscience 2007, researchers at Oregon Health and Science University (OHSU) presented results of a study that used ACT RPE cells manufactured under GMP conditions (21CFR211) at the company’s facility in Worcester, Massachusetts. The RPE cells were thoroughly characterized and cryo-preserved and shipped to researchers at OHSU for transplantation. The conclusions drawn by researchers were that visual function can be rescued and preserved in this animal model of disease utilizing ACT’s GMP-manufactured human ES-derived RPE cells with a functional dose threshold and that these cells may provide an effective donor cell source to rescue photoreceptors in conditions like AMD, where RPE function is compromised.

The next step in the development of the program will be to complete several safety studies utilizing the GMP-manufactured RPE cells. Pilot studies to date have shown the cells to be safe, well tolerated, and non-migratory. The Good Laboratory Practice (GLP) compliant studies are required prior to filing an IND. The safety studies will include several key areas of examination, including, tumorigenicity potential, cell tolerability, cell survival, general safety, and potential for biodistribution.

“We are pleased to complete this key milestone as we move our RPE program toward the clinic,” said William Caldwell, IV, Chairman and CEO of Advanced Cell Technology. “Based upon our cell characterization data, pharmacology studies, and the overall safety profile, we are excited by the prospects for this program and the potential to treat a large unmet medical need. The successful completion of our Pre-IND meeting represents another step forward towards the filing of the IND for our RPE Program and ultimately bringing the therapy to the bedside. We are one step closer to bringing our second stem cell therapy to patients in need.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying embryonic stem cell technology in the emerging field of regenerative medicine. The company operates facilities in Alameda, California and Worcester, Massachusetts.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-QSB for the quarter ended September 30, 2006. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Dan Schustack, 212-732-4300

Source: Business Wire (February 1, 2008 - 9:29 AM EST)

Advanced Cell Technology Announces Creation of Human Embryonic Stem Cell Lines Without the Destruction of Embryos

2008-01-10T16:01:00Z

-Breakthrough Approach Improves Efficiency to Levels Reported in the Conventional Stem Cell Derivation Techniques-

Advanced Cell Technology, Inc. (OTC Bulletin Board: ACTC) together with colleagues announced today the development of five human embryonic stem cell (hESC) lines without the destruction of embryos. These new results have the potential to end the ethical debate surrounding the use of embryos to derive stem cells. In fact, the NIH report to the President refers to this technology as one of the viable alternatives to the destruction of embryos.

The new method will be published today in the journal Cell Stem Cells, published by Cell Press. The peer-reviewed technique was initially carried out by ACT scientists under the direction of Robert Lanza, M.D., and then independently replicated by scientists on the West Coast. Single cells were removed from the embryos using a technique similar to preimplantation genetic diagnosis (PGD). The biopsied embryos continued to develop normally and were then frozen. The cells that were removed were cultured utilizing a proprietary methodology that recreates the optimal developmental environment, which substantially improved the efficiency of deriving stem cells to rates comparable to using the traditional approach of deriving stem cells from the inner cell mass of a whole blastocyst stage embryo. The stem cells were genetically normal and differentiated into cell types of all three germ layers of the body, including blood cells, neurons, heart cells, cartilage, and other cell types of potentially therapeutic significance.

“This is a working technology that exists here and now,” said Robert Lanza, M.D., Chief Scientific Officer at Advanced Cell Technology and senior author of the paper. “It could be used to increase the number of stem cell lines available to federal researchers immediately. We could send these cells out to researchers tomorrow. If the White House approves this new methodology, researchers could effectively double or triple the number of stem cell lines available within a few months. Too many needless deaths continue to occur while this research is being held up. I hope the President will act now and approve these stem cell lines quickly.”

The paper published today also addresses several other important issues. First, the stem cells were derived without culturing multiple cells from each embryo together, and at efficiency levels similar to that reported for conventional stem cell derivation techniques using blastocysts. Second, it addresses ethical objections that the derivation system required co-culture with hESCs from other embryos that were destroyed. The current study demonstrates that hESC co-culture is not an essential part of the derivation procedure. The stem cell lines generated in the present study appear to have the same characteristics as other hESC lines, including expression of the same markers of pluripotency, self-renewing capacity, genetic stability, and ability to differentiate into derivatives of all three germ layers of the body.

“We are excited that our new method for generating human embryonic stem cell lines without the destruction of embryos has been accepted for inclusion by such a prestigious publication,” said William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology. “This new approach addresses the President Bush’s ethical concerns. We are hopeful that the NIH will consider this new approach for federal funding. We believe that such consideration reflects the desire of the American people to bring therapies derived from stem cell research to patients with few or no alternatives.”

Other contributors to the study and publication include Young Chung and Irina Klimanskaya, Sandy Becker, Tong Li, Marc Maserati, and Shi-Jiang Lu of Advanced Cell Technology; Tamara Zdravkovic, Olga Genbacev, and Susan Fisher of the University of California, San Francisco; and Dusko Ilic and Ana Krtolica of StemLifeLine.

About Advanced Cell Technology, Inc.

Forward-Looking Statements

Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-QSB for the quarter ended September 30, 2007.

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Andrew Hellman, 212-732-4300
or
Cell Stem Cells:
Cell Press
Cathleen Genova, 617-397-2802

Source: Business Wire (January 10, 2008 - 12:01 PM EST)

Advanced Cell Technology Awarded Grant from the NIH

2008-01-08T12:29:00Z

Grant to Support Research on Therapeutic Potential of Pure Lineage Restricted Cells Derived from hESCs

Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that the National Institute of General Medical Sciences at the National Institutes of Health (NIH) has awarded the company an SBIR Phase 1 Small Business Grant. The company will use the grant proceeds to conduct research that will allow for rapid labeling and purification of specific lineage restricted cells (LRCs) in cultures of differentiating human embryonic stem cells. If successful, the research will help the company more rapidly develop new regenerative therapies for a variety of indications including cardiovascular disease as well for commercialization of the LRCs and their peptide-targeting agents as research reagents. The research aims to create a process by which specific markers can be identified that will act like nametags allowing LRCs to be identified and then purified. With such markers, unique populations of cells can be isolated so that the benefits of these cells can be tested. The research grant from the NIH follows a previous NIH STTR grant award to ACT for a research project from the organization's National Institute for Dental and Craniofacial Research (NIDCR) announced in January 2007.

"We are pleased that prestigious institutions such as the NIH continue to recognize and support our research and development programs," said William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology. "We will continue to work with the NIH and other organizations to raise awareness and capital to support our ongoing research and commercialization projects without diluting shareholder value. We also remain hopeful that the NIH will ultimately fund our single cell biopsy technique for generating human embryonic stem cell lines without damaging the developmental potential of the embryos."

In August 2006, ACT scientists published a paper in the journal Nature explaining its single-cell biopsy technique for generating hESC lines without destroying the developmental potential of the underlying embryos. In June 2007, the company announced that it had successfully produced such a line. That same month, President Bush issued an Executive Order requiring the Secretary of Health and Human Services to conduct and support research on the isolation of pluripotent stem cells derived without destroying or harming human embryos. In September 2007, the NIH announced that it would begin implementing President Bush's Executive Order and that ACT's single cell biopsy technique was one of the methods under consideration for funding.

"As we've stated before, we believe our single cell biopsy technology directly addresses the President's ethical concerns and, unlike the other potential solutions described in the Executive Order, is available today," continued Mr. Caldwell. "We are encouraged by the NIH's willingness to explore ways to increase the federally approved stem cell lines available. We believe that such consideration reflects the will of the American people to bring novel therapies derived from stem cell research to patients with few or no alternatives.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com.

Forward-Looking Statements

Investors:
CEOcast, Inc. for Advanced Cell Technology, Inc.
Daniel Schustack, 212-732-4300
or
Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523

Source: Business Wire (January 8, 2008 - 8:29 AM EST)

Advanced Cell Technology Issues Letter to Investors

2007-12-19T15:53:00Z

Investor Letter Highlights Company’s Progress Year-to-Date

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that it has issued a letter to its investors from William M. Caldwell, IV, Chairman and CEO, updating the company’s progress year-to-date. The text of the letter is available on the company’s website at www.advancedcell.com and is included in this press release below:

Dear Stockholders,

As we move through 2007’s holiday season and approach year end, I wanted to update all of you about the events that took place for our company this year. 2007 has been a year of significant scientific accomplishment and positive transformation for Advanced Cell Technology as well as one of great change for the regenerative medicine industry. I have broken this letter into four components. First and foremost, I would like to discuss our research, development, and clinical progress, as this is clearly the most important facet of our company. Second, I will discuss Advanced Cell Technology’s transformation from a research and development organization into a biotechnology company with novel therapies in clinical trials for currently difficult or impossible to treat indications. Third, I will outline our interpretation of the state of the stem cell industry. And finally, I will discuss what our hopes and expectations are for 2008 and beyond.

Scientific Progress

Advanced Cell Technology has three primary therapeutic programs:

1) our Myoblast Program, an autologous adult stem cell therapy for the treatment of heart failure;

2) our Retinal Pigmented Epithelial (or RPE) cell Program, an embryonic stem cell therapy for the treatment of degenerative retinal disorders; and

3) our Hemangioblast (or HG) cell Program, an embryonic stem cell therapy for the treatment of blood and cardiovascular indications.

We have made progress in each of these programs this year and will exit 2007 with the Myoblast Program preparing to enter Phase II human clinical trials and our RPE and HG Programs in preclinical trials. In addition, our company has a number of proprietary technology platforms, including our single cell biopsy technique for creating embryonic stem cell lines without destroying embryos.

Myoblast Program

Milestones:

Acquired Mytogen, Inc., and its Myoblast therapy for the treatment of heart failure. Therapy successfully completed Phase I human clinical trials.
Presented 6-month data at TCT 2007 demonstrating safety and improvement in heart failure measures.
Presented 12-month data at the AHA’s 2007 conference in Orlando demonstrating safety and persistence of therapeutic effect over an extended period of time.
Entered into a letter of intent with Catholic Healthcare West for a proposed exclusive business arrangement to establish a clinical trial research site and a North American regenerative medicine interventional cardiology training center for our Phase II Myoblast clinical trial.
Pursuing international partnerships for Phase II human clinical trials.
On schedule to begin Phase II human clinical trials at eight sites shortly.

We acquired our Myoblast Program in connection with our acquisition of privately-held Mytogen, Inc., which closed in September 2007. The myoblast therapy involves transplantation of expanded autologous myoblasts derived from a small biopsy of skeletal muscle from a patient’s leg. The myoblasts are expanded into hundreds of millions of cells over a period of three weeks and then transplanted back into the patient’s scarred heart tissue via a catheter-based procedure. The Myoblast Program to date has successfully completed four Phase I human clinical trials utilizing the therapy safely in over 40 patients. While the successful Phase I human clinical trials were focused on the safety of the therapy, the clinical data from those trials suggested that the myoblasts can improve heart function that leads to an improved quality of life for the patient.

In October and November of this year, Dr. Nabil Dib, one of the principal investigators for our Myoblast Program, presented 6-month and 12-month data for the program at TCT 2007, a leading interventional cardiology conference, and at the American Heart Association’s annual meeting in Orlando, Florida, respectively. The two sets of data: 1) demonstrated myoblast safety with no evidence for increased risk of arrhythmia; 2) distinguished the ACT Myoblast Program as the leader in the industry as it is the only program not required to use anti-arrhythmia medications and/or an implanted defibrillator device; 3) showed that the effects of ACT’s myoblast therapy persisted for an extended period of time, an effect that has not been demonstrated by any other cellular therapy for heart disease; 4) provided evidence that the hearts of the patients that received the therapy showed less cardiac remodeling in comparison to controls, remodeling being a progressive enlargement of the heart that signifies worsening of function; and 5) that by using the ACT technology doctors have for the first time the opportunity to successfully replace scarred heart tissue with healthy muscle via intracardiac injections of autologous skeletal myoblasts.

We are on schedule to begin the Phase II human clinical trial for the treatment of heart failure in approximately 160 patients. In that light, we entered into a letter of intent with Catholic Healthcare West, America’s eighth largest hospital system, for a proposed exclusive business arrangement to establish a clinical trial research site and a North American regenerative medicine interventional cardiology training center for our Phase II Myoblast clinical trial. In addition, we are actively pursuing international partnerships to investigate our Myoblast Program and to commence international Phase II human clinical trials for the novel therapy. If the Phase II trials prove successful, we will proceed with a pivotal Phase III trial.

According to the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), approximately 5 million people in the United States have congestive heart failure (CHF) and an estimated 400,000 new cases are diagnosed each year. Roughly 50% of CHF patients die within 5 years. The annual number of deaths directly from CHF increased from 10,000 in 1968 to 42,000 in 1993, with another 219,000 related to the condition. CHF is the first-listed diagnosis in 875,000 hospitalizations, and the most common diagnosis in hospital patients 65 years and older. Consequently, we are excited by both the market opportunity for our Myoblast Program as well as the potential to help the growing number of patients suffering from heart failure in the United States and abroad.

Retinal Pigmented Epithelial (RPE) Program

Milestones:

Demonstrated visual function rescue in Royal College of Surgeons (RCS) rats in 2006.
Entered into a research services agreement with the Casey Eye Institute at OHSU for preclinical studies.
Published OHSU dosage study results demonstrating a statistically significant positive therapeutic effect.
Began preliminary discussions with the FDA to initiate clinical studies.
Contracted with a leading contract research organization for an extensive preclinical program.
MPI Research initiated pilot studies under Good Laboratory Practices (GLP).
Provided we receive positive feedback from the FDA, plan to file IND in 2008.

Studies of our proprietary RPE cells have shown that the therapy may ultimately provide effective treatment of degenerative retinal disorders, including macular degeneration, which represents a $28 billion dollar market. Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 in the United States. The prevalence of AMD begins to increase after the age of 50. Approximately 15% of people over 75 have the condition. To date, AMD patients have had few if any effective therapies for treatment; thus, the need for novel therapies that we are developing is clear.

In 2006, we demonstrated visual function rescue in rat models using our RPE therapy. In February of this year, we entered into a research services agreement with Oregon Health and Science University (OHSU). Under the terms of the research agreement, we have been collaborating with Dr. Raymond Lund, Dr. Richard Weleber, and Dr. Peter Francis at the Casey Eye Institute at OHSU to conduct preclinical studies for the program. Specifically, the research team has been conducting dosage studies utilizing our RPE cells in the RCS rat model and plans to conduct similar studies in other rodent models of retinal degenerative disease. We are also in discussions with the OHSU team regarding future plans for a Phase I human clinical trial.

In November of this year at Neuroscience 2007, researchers at OHSU presented results of the study, which used ACT RPE cells that were manufactured under GMP compliant conditions (21CFR211) at our facility in Worcester, Massachusetts. The RPE cells were thoroughly characterized and cryo-preserved and shipped to researchers at OHSU for transplantation. The transplanted rats were given a range of doses of the RPE cells and monitored and evaluated at multiple time points. The results of the study showed that the RPE cells demonstrated a statistically significant therapeutic effect compared to controls with a maximum efficacious effect at an intermediate dose level. Histological assessment showed integration of the human RPE cells into the rodent’s RPE layer without migration into the retina. The conclusions drawn by researchers were that visual function can be rescued and preserved in this animal model of disease utilizing GMP-compliant human ES-derived RPE cells with a functional dose threshold and that these cells may provide an effective donor cell source to rescue photoreceptors in conditions like AMD, where RPE function is compromised. We plan to present this data to the FDA when we file an IND for the therapy.

As we move closer to filing an IND for our RPE therapy, we decided to initiate preliminary discussions with staff from the Office of Cellular, Tissue, and Gene Therapies within the Center for Biologics Evaluation and Research at FDA. These discussions took place earlier this year. In addition, we contracted with a leading contract research organization to begin work on an extensive preclinical program. Furthermore, MPI Research, located in Mattawan, Michigan, initiated pilot studies under Good Laboratory Practices (GLP) for the ongoing RPE Program. We are hopeful that we can file an IND for the RPE therapy next year and begin human clinical trials soon thereafter.

Hemangioblast (HG) Program

Milestones:

Published research in Nature Methods demonstrating HG cells’ ability to repair vascular damage in animals.
Seeking international partnerships for preclinical and clinical trials.
Targeting IND filing in 2008.

We continue to investigate the possibility of using our proprietary hemangioblast cells to treat blood and cardiovascular diseases, stroke and cancer. In May of this year, research conducted by our team of scientists and our collaborators from the University of Florida at Gainesville and the Memorial Sloan-Kettering Cancer Center in New York City was published in the journal Nature Methods. The research described an efficient method for generating large numbers of hemangioblasts derived from human embryonic stem cells that were capable of differentiating into blood vessels as well as into all blood and immune cell lineages. When the cells were injected into animals that had retinal damage from diabetes or ischemia-reperfusion injury (lack of adequate blood flow) of the retina, the cells homed to the site of injury and showed robust reparative function of the entire damaged vasculature within 24 to 48 hours. The cells showed a similar regenerative capacity in animal models of both myocardial infarction (50% reduction in mortality rate) and hind limb ischemia, with restoration of blood flow to near normal levels.

We are actively seeking international partnerships for our HG Program to assist with our preclinical research and, ultimately, human clinical trials. We are hopeful that we can file an IND next year for the program and move forward with human clinical trials.

Single Cell Biopsy Embryonic Stem Cell Development Technique

Milestones:

Last year we described our proprietary single cell biopsy technique for creating human embryonic stem cell lines without damaging embryos.
Announced the creation of the first human embryonic stem cell line without destroying an embryo this year, quelling much of the initial controversy.
The NIH is considering our single cell biopsy technique for federal funding.

Our single cell biopsy technique for creating human embryonic stem cell lines without damaging embryos continues to attract a significant amount of attention. Recall that in August of last year we announced that our scientists had published a paper in the journal Nature explaining how they had generated human embryonic stem cells using this approach. The method derives the cells from human blastomeres with a single-cell biopsy technique called Preimplantation Genetic Diagnosis (PGD). This technique is used by in vitro fertilization clinics to assess the genetic health of preimplantation embryos. The cell lines produced using this technique appeared to be identical to human embryonic stem cell lines derived from later stage embryos using techniques that destroy the embryo’s developmental potential. A significant amount of controversy ensued after our announcement challenging the validity of the results, but we were pleased to report in June of this year that we had successfully produced a human embryonic stem cell line without destroying an embryo at our lab in Worcester, Massachusetts. Dr. Robert Lanza, M.D., our Chief Scientific Officer, definitively announced that he and his team had reproduced the work of removing a single cell blastomere from a human embryo with the surviving embryo cryo-preserved, quelling much of the initial controversy.

The technique is also beginning to attract the attention of our federal government. In June of this year, President Bush issued an Executive Order requiring that “The Secretary of Health and Human Services … conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.” Roughly three months later, the NIH announced that it would begin implementing President Bush’s Executive Order. Our single cell biopsy technique was cited by the NIH as an alternative method in its implementation plan. The NIH plan calls for “aggressively pursuing an assessment of the potential of alternative sources of pluripotent stem cell lines, including altered nuclear transfer; single cell embryo biopsy, and reprogramming, or dedifferentiation of somatic cells, such as skin cells.”

We believe our single cell blastomere technology directly addresses the President’s ethical concerns and, unlike the other potential solutions described in the order, is available today. We are encouraged by the NIH’s willingness to explore ways to increase the federally approved stem cell lines available and hope they will consider our technique for federal funding. We believe that such consideration reflects the will of the American people to bring novel therapies derived from stem cell research to patients with few or no alternatives.

The Transformation of Advanced Cell Technology

Milestones:

Acquired Mytogen and transformed from a development stage to a clinical stage company.
Solidified our management team by naming Dr. Lanza Chief Scientific Officer, Dr. Dinsmore Senior VP – Clinical and Regulatory, and Ivan Wolkind Senior VP – Finance, Administration and Chief Accounting Officer.
Improved our patent portfolio to 380 owned or licensed patents and patent applications.
Received and/or participated in grants from the NIH and CIRM.
Raised $10 million in gross proceeds from the private placement of senior secured convertible debentures.

Earlier this year, our company was presented with a unique opportunity that culminated in a merger with Mytogen, Inc. We entered into a letter of intent to acquire Mytogen in May, signed a definitive merger agreement in July, and closed the acquisition in September. The Mytogen transaction was transformational for Advanced Cell Technology for several reasons. First, Mytogen helped us broaden our regenerative medicine technology platform from exclusively focused on embryonic stem cell therapies to research programs and therapies based on both embryonic and adult stem cell technology. This technology platform expansion has allowed us to not only investigate more new therapies for a larger set of indications, but it has also provided access to opportunities largely unavailable to companies focused exclusively on embryonic stem cell science. Second, what with the Myoblast Program having successfully completed Phase I human clinical trials and poised to begin Phase II human clinical trials shortly, the Mytogen acquisition immediately transformed ACT from a development stage to a clinical stage company.

With the merger closed and the Mytogen team fully integrated into the Advanced Cell Technology family, we solidified our management team. While I remain Chairman and CEO, we named Dr. Robert Lanza, M.D., our Chief Scientific Officer; Dr. Jonathan Dinsmore, Ph.D., our Senior VP - Regulatory and Clinical; and Ivan Wolkind our Senior VP - Finance, Administration & Chief Accounting Officer. Dr. Lanza has over 25 years of relevant research and industrial experience, including his position as Director of Transplantation Biology at BioHybrid Technologies, Inc. He is currently an Adjunct Professor at the Institute for Regenerative Medicine, Wake Forest University School of Medicine, and has several hundred scientific publications and patents and has authored and/or edited 16 books. Dr. Dinsmore was formerly responsible for all aspects of Mytogen’s cell production operations, basic science program, and research and development efforts, and directed both clinical and preclinical research programs at Diacrin and GenVec. Mr. Wolkind joined ACT in March 2005 after serving as the Executive Vice President of Finance and CFO for Eyematic. Mr. Wolkind previously held senior financial positions at a number of large companies and worked in the financial services and banking audit group at KPMG.

Our corporate transformation also allowed us to consolidate and improve our patent portfolio. In February, we acquired the intellectual property assets of Infigen, Inc. relating to parthenogenesis, oocyte activation and other related technologies. We acquired a total of 26 issued patents and numerous pending patent applications for a combination of cash and shares of common stock. Three months later in May we announced an expanded, non-exclusive commercialization agreement with Wisconsin Alumni Research Foundation (WARF) that granted us rights to the commercial use of human embryonic stem cells to develop human therapies (with the exception of neuronal, pancreatic beta cells, and cardiac applications) and enabled the marketing of a broad array of research products. The agreement granted us commercial access to an additional 150 important stem cell technology patents and patent applications. As a result of the Infigen, WARF, and Mytogen deals, we now own or license over 380 patents and patent applications.

2007 was another challenging year for financing companies in our space, what with difficult public markets (especially in biotechnology) and the ban on federal funding for many areas of stem cell research. Nevertheless, we successfully exploited a handful of alternative financing opportunities. In January, our company was awarded a research grant from the NIH in conjunction with a research project currently underway with The Burnham Institute of Medical Research, one of our academic partners. The grant, titled “Directed Differentiation of Embryonic Stem Cells using Phage Displayed Ligands,” further funds research by ACT and The Burnham Institute aimed at obtaining specialized cells of therapeutic interest from human embryonic stem cells using NIH-approved stem cell lines. Furthermore, as the $3 billion in funding to be distributed by CIRM (the California Institute for Regenerative Medicine) over 10 years from California’s Proposition 71 begins to trickle out, we have seen some early positive developments including the use of ACT’s human embryonic stem cells in a study to determine if the cells are safe and effective in animal models for heart attacks and heart failure.

Our most substantial capital raise this year came from the completion of a private placement of senior secured convertible debentures that closed in August resulting in gross proceeds of $10 million. The cash infusion provided us with capital necessary to continue our promising research and development platforms and has brought us closer to both additional clinical trials and, ultimately, to commercializing our therapies in the marketplace.

The State of the Stem Cell Industry

Politics

The legislative environment for stem cell research is complex and largely misunderstood; consequently, I’d like to outline for you the facts as well as how we see the legislative landscape unfolding going forward. In August 2001, President Bush enacted a ban on federal funding for deriving new embryonic stem cells from fertilized embryos. This does not mean that embryonic stem cell research is “illegal,” rather that federally collected tax dollars cannot be used to fund the research. Unfortunately, however, because of the federal funding ban, research institutions (be they public, private, academic, etc.) have been forced to build entirely “clean” facilities to be used exclusively for such research. This has resulted in a significant (financial) barrier to research progress. Furthermore, while President Bush did allow research to continue on the embryonic stem cell lines existing at that time – often referred to as the “Presidential Lines” – (unbeknownst to the President) the lines are contaminated and largely unusable. Despite the challenging environment, we, as a company, have made the progress I’ve outlined in this letter.

Still, there have been a number of initiatives aimed at improving the landscape to further research in this field at both the federal and state levels. In July 2006, the Senate voted 63-37 in favor of a bill that passed in the House of Representatives to lift the ban on federal funding of stem cell research, but the bill did not have enough support to override the President’s inevitable veto. In January and April of this year, the House and the Senate, respectively, passed the Stem Cell Research Enhancement Act of 2007. Once again, however, in each vote the bill came just a few “ayes” shy of a veto-proof majority. Despite these (largely expected) legislative defeats, we believe it is becoming increasingly clear that it is a matter of when, not if, federal support of embryonic stem cell research will become reality. According to some polls, roughly two thirds of the American populous is in favor of lifting the restrictions and with the 2008 Presidential election approaching swiftly we believe that change for the better is very near, especially considering the pro-embryonic stem cell research stance of a large number of the leading Presidential candidates. Should the election bring a change in the position of the executive branch, it would remove the last impediment to opening up the floodgate of billions of dollars in federal support for companies like ours.

While a lift on the federal funding ban would certainly benefit our company, our success does not rely solely on such change. In addition to the progress we’ve made in the current less-favorable environment, there are additional initiatives at the federal level that may benefit Advanced Cell Technology. Most specifically, as discussed above, the NIH announced this year that it would begin implementing President Bush’s Executive Order to seek alternative sources of pluripotent stem cell lines, including lines created using our single cell blastomere technology. We are encouraged that our government is seriously considering our technology for funding.

We have also seen continued developments at the state level. Our experiences in California, where our headquarters is located, thus far have been positive including being named this year on a CIRM grant whose recipient will use ACT’s human embryonic stem cells to determine if the cells are safe and effective in animal models for heart attacks and heart failure. CIRM funds are finally beginning to get distributed to grant winners. Furthermore, this year CIRM is beginning to award grants to for-profit organizations (like our own) – prior, all of the grants announced had been for non-profit organizations (who can subcontract as much as 50% of the grant to for-profit organizations). New Jersey had proposed a $450 million bond to fund stem cell research that, unfortunately, was defeated; however, we believe the vote was more a reflection of the voters’ dissatisfaction with state government spending (New Jersey has a $3 billion budget deficit) rather than a referendum on the ethics and feasibility of stem cell science. In November of this year in Massachusetts, where in 2005 the state’s congress overrode and passed a bill, which former-Governor Romney had vetoed, supporting embryonic stem cell research, Governor Deval Patrick proposed a $1 billion stem cell research funding initiative. Also, states including Connecticut, Florida, Illinois, Maryland, New York, and Missouri have passed or proposed similar initiatives. Again, it is our belief that we are nearing the moment when funding for stem cell research will begin to expand. We expect to be a direct beneficiary of the improving climate.

Scientific Developments

This year, scientists including our own as well as researchers outside our company announced a number of regenerative medicine breakthroughs. In addition to our single cell biopsy embryonic stem cell development technique, researchers around the world announced advances such as deriving stem cells from amniotic fluid and skin cells. In January of this year, scientists at Wake Forest University and Harvard University reported that stem cells from amniotic fluid donated by pregnant women may hold promise for pluripotency. We believe the cells may generate a broad range of important cell types, though they may not do as many tricks as embryonic cells. In addition, in November researchers in Japan and the United States announced that they had reprogrammed skin cells to behave like embryonic stem cells. Generating stem cells in this manner has several obstacles to overcome, including dealing with a carcinogenic effect, and likely will not be viable for years to come. Regardless, all of these scientific breakthroughs represent a giant steps forward for stem cell research.

Looking Forward

We expect to enter 2008 on solid footing and look forward to an exciting year. We remain on schedule to begin Phase II human clinical trials for our myoblast adult stem cell therapy for heart failure and are working diligently in preparation for IND filings for our RPE and HG embryonic stem cell therapies for retinal degenerative disorders and heart, blood, and cardiovascular indications, respectively. We are also excited to be seeking international partnerships for each of our clinical and preclinical programs to tap into global market prospects, international scientific expertise, and worldwide non-dilutive financing opportunities. We remain committed, determined, and focused on bringing novel treatments for difficult and impossible to treat indications from the lab to the bedside as well as on returning value to our shareholders.

Wishing you the best for the holiday season and the new year,

William M. Caldwell, IV

Chairman and CEO

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Andrew Hellman, 212-732-4300

Advanced Cell Technology Seeking International Partners for Its Therapeutic Programs

2007-12-06T12:10:00Z

Burrill & Company Hired to Advise on International Partnerships

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that it is seeking international partners for each of its three lead therapeutic programs, including its Myoblast program for treating heart failure, its Retinal Pigment Epithelium program for treating degenerative retinal disease, and the Hemangioblast program for the treatment of blood and cardiovascular indications. The company is making significant progress in the development of each of these therapeutic programs within the United States.

Advanced Cell Technology has made a strategic decision to seek partners for each of these programs internationally, including regions such as Europe, the Middle East and Asia, as the company recognizes that there is strong interest in the field of stem cells worldwide. ACT has asked Burrill & Company, which it hired last year to advise on a number of strategic initiatives, to renew its focus on seeking international partners. Interested parties worldwide should contact Mr. William Caldwell, IV, Chairman and CEO of Advanced Cell Technology at 310-481-5124.

“We recognize that there is material interest in the stem cell and regenerative medicine field globally and will seek strong partners from the worldwide medical community to pursue our programs outside of the United States and complement the work we are doing at home. We are very pleased to continue our successful relationship with Burrill & Company and utilize their extensive global network to further these discussions,” said Mr. William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com

Forward-Looking Statements

Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
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Advanced Cell Technology's Chief Executive Officer Scheduled to Be Interviewed By Bloomberg Television Tonight

2007-11-20T19:46:00Z

Executive to Discuss Company’s Retinal Program and Recent Industry Issues

Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that William M. Caldwell, IV, the company’s Chief Executive Officer is scheduled to be interviewed today by Bloomberg Television at 6:15 p.m. eastern time. Mr. Caldwell is expected to discuss the Company’s Retinal Program, as well as other corporate developments and issues surrounding the stem cell industry.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com .

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-QSB for the quarter ended June 30, 2007. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Andrew Hellman, 212-732-4300

Advanced Cell Technology Announces 12-Month Results of Myoblast Therapy Trial

2007-11-07T16:34:00Z

Results Presented at Late Breaking Trial Sessions at AHA Annual Meeting

Advanced Cell Technology, Inc. (OTCBB: ACTC) today announced that a controlled, randomized clinical trial using ACT’s myoblast therapy demonstrated marked improvement in heart failure symptoms after both six and twelve months. ACT had already published 6-month data for the trial. The positive 12-month results announced today demonstrate that the effects of ACT’s myoblast therapy persist for an extended period of time, an effect that has not been demonstrated for any other cellular therapy for heart disease. The trial also showed evidence that the hearts of the patients that received the therapy showed less cardiac remodeling (an increase in the size of the heart that signifies worsening of function) than did control patients. Principal investigator Dr. Nabil Dib, Director, Clinical Cardiovascular Cell Therapy, University of California, San Diego and Director of Cardiovascular Research at Chandler Regional Medical Center and Mercy Gilbert Medical Center, Phoenix, AZ, presented the results of the trial today in a Late Breaking Clinical Trial Session at the American Heart Association’s annual meeting in Orlando, Florida.

The trial marks the first time in the United States that scientists performed a controlled, randomized clinical trial using catheter-delivered muscle stem cells to treat congestive heart failure, a condition marked by progressive weakening of the heart and failure of the heart to pump blood properly. Patients with congestive heart failure often have scar tissue in the heart, which limits the heart’s ability to pump blood and contributes to continued atrophy of the heart. Standard multi-drug therapy and surgery can help slow but not stop the decline in heart function. Using these existing therapies, ultimately patients have no treatment options besides heart transplant or being outfitted with a mechanical pump to assist the heart. The data presented today suggests that by using the ACT technology doctors now have the opportunity to successfully replace scarred heart tissue with healthy muscle via intracardiac injections of autologous skeletal myoblasts (ASMs).

The clinical trial enrolled 23 patients with poor cardiac output and congestive heart failure. The control group consisted of 11 patients on standard drug therapy while the experimental group was given varying doses of 30, 100, 300, or 600 million ASMs. Using a catheter and transplanting ASMs into scarred tissue, the trial suggests that new living muscle may be forming in the hearts of patients in the study. The transplanted stem cells, harvested from the patients’ own muscles, are compatible with the body and avoid possible tissue rejection that often accompanies organ transplantation. The procedure uses a minimally invasive catheter approach, which reduces the risk of surgical complications as no anesthesia is required and only a small incision is necessary for catheter access. Patients can be discharged within 24 hours of the procedure.

“In this study, we learned that there is hope for using the body’s own reparative cells to help the failing heart,” said Dr. Dib. “We need to continue research in this area to determine if this kind of procedure is effective in treating a larger, more diverse group of patients.”

A Phase II human clinical trial is planned and will utilize 3-Dimensional Guided Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ishemic Cardiomyopathy (CAuSMIC). The trial, which will be open for enrollment in the next few months, will be led by principal investigator Dr. Dib and will target patients who are not eligible for angioplasty or coronary artery bypass surgery and who continue to have poor quality of life despite receiving optimal medial therapy or cardiac resynchronization therapy with a pacemaker or defibrillator device.

“We are encouraged by the data Dr. Dib presented from the results of our myoblast trial,” noted William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology, Inc. “The positive 12-month data presentation represents another step in our process of initiating a Phase II human clinical trial for our myoblast therapy. We look forward to moving the myoblast and other stem cell therapies through the clinic and ultimately to patients in need of treatment.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.

For more information, visit www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-QSB for the quarter ended June 30, 2007. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Andrew Hellman, 212-732-4300

Source: Business Wire (November 7, 2007 - 12:34 PM EST)