Advanced Cell Technology Announces Catheter Supply Agreement with Biologics Delivery Systems Group.Agreement Represents Progress Toward Commencing Phase II Human Clinical Trials for Myoblast myoblast /myo·blast/ (mi´o-blast) an embryonic cell which becomes a muscle cell or fiber.myoblas´tic my·o·blast n. A primitive muscle cell having the potential to develop into a muscle fiber. Therapy LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. -- Advanced Cell Technology, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : ACTC ACTC Apple Certified Technical Coordinator ACTC Almaden Cycle Touring Club ACTC Associated Colleges of the Twin Cities ACTC All Ceylon Tamil Congress (Sri Lanka) ACTC Association Canadienne de Télévision par Câble ) 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 autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. myoblasts (adult progenitor pro·gen·i·tor n. 1. A direct ancestor. 2. An originator of a line of descent. progenitor ancestor, including parent. progenitor cell stem cells. stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young ) 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , poor quality of life, and long-term deterioration. According to the National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute, n.pr established in 1948, this division of the National Institutes of Health is responsible for research and education on cardiovascular, pulmonary, systemic diseases, and sleep disorders. , 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 CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 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 NOGA Northern Ohio Golf Association NOGA National Oil and Gas Assessment [R] Cardiac Navigation System and MyoStar[R] Injection Catheter. "The NOGA[R] 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion