Agreement Represents Progress Toward Commencing Phase II Human Clinical Trials for Myoblast Therapy
Los Angeles, CA, March 5, 2008 - Advanced Cell Technology, Inc. (OTCBB: ACTC - News) 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 "http://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 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.
Chad Griffin Consulting, Inc.