Myoblast Therapy to be Presented to World's Foremost Cardiovascular Medical Professionals
LOS ANGELES-- (BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB: ACTC - News) today announced that the American Heart Association (AHA) has selected the company's Myoblast Phase I (b) trial as a featured late breaking trial for its annual Scientific Sessions Conference in Orlando Florida on November 4, 2007 through November 7, 2007. The AHA's Scientific Sessions Conference is among the premier cardiovascular research and instructional meetings worldwide bringing together interventional cardiologists, electrophysiologists, and nurses and other professionals with content from the forefront of research and clinical practice, including more than 4,000 abstracts of original research and a variety of invited programs. In addition, an International Congress on Stem Cells and Myocardial Regeneration will run concurrently with Scientific Sessions, featuring the most internationally renowned investigators in the field.
Advanced Cell Technology's myoblast therapy (acquired via its acquisition of Mytogen, Inc.) 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 3-D electromechanical mapping based-catheter procedure, which differs from a number of competitive therapies that may require open heart surgery or a less precise catheter-based system to deliver new cells. Since ACT's technology has never necessitated the use of accompanying arrhythmia preventatives usually required for similar programs, ACT will be permitted to conduct its Phase II trials without anti-arrhythmia precautions as well. The FDA has required studies of competitive therapies to use anti-arrhythmia medications and/or implanted defibrillators because of the safety risks involved with those treatments. In contrast, because of ACT's positive safety record with its Myoblast Program, the FDA has not put such restrictions on the ACT myoblast therapy.
"We have spent many years of research devoted to making our myoblast product the safest and most effective in the industry," noted Dr. Jonathan Dinsmore, Ph.D., Vice President and General Manager at Advanced Cell Technology. "It is gratifying to see that work translate into positive, clinical safety and survival data."
The Myoblast Program has successfully completed Phase I human clinical trials utilizing the therapy safely in over forty patients. Safety of the company's myoblast therapy has been demonstrated in four independent studies, all conducted under FDA oversight. The FDA has reviewed the "end-of-Phase I" data and will allow Advanced Cell Technology to proceed with a Phase II human clinical trial. The company plans to begin the Phase II human clinical trial for the treatment of heart failure in approximately 160 patients. Dr. Nabil Dib, an interventional cardiologist at University of California at San Diego's School of Medicine, will serve as a consultant to the company and lead the cellular transplantation team to advance the Myoblast Program clinical efficacy trials. If the Phase II human clinical trials are successful, the company expects to proceed with a pivotal Phase III trial. The Myoblast Program may prove particularly beneficial for patients that have experienced a serious heart attack and have a high risk of heart failure.
William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology commented, "We are delighted that the American Heart Association has recognized the potential for our Myoblast Program to effectively treat patients with heart failure via its inclusion of the study in its November conference. We look forward to moving into Phase II human clinical trials and ultimately bringing this and other stem cell therapies to the bedside."
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":http://www.advancedcell.com.
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.
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.
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