Amorcyte Secures Production Capacity for Lead Cell Therapy Product; Progenitor Cell Therapy LLC is Retained to Develop and Manufacture AMR-001
Posted on: Tuesday, 27 June 2006, 15:00 CDT
Amorcyte Inc (Amorcyte), a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, announced today that it has signed an exclusive agreement for the development and manufacturing of Amorcyte's lead product, AMR-001, with Progenitor Cell Therapy, LLC (PCT), a leading full service cell therapy development and contract manufacturing company.
"The product development and manufacturing agreement with Progenitor Cell Therapy is a critical component of our corporate and product development plan," explains Dr. Thomas Moss, Amorcyte's Chief Medical Officer. "Our strategic relationship with PCT enables our development team to draw on PCT's unique and extensive investigative, regulatory and commercial experience in the applied cell therapy field."
"Leveraging PCT for development of AMR-001 will allow Amorcyte to reduce capital outlay. This will contribute to efficient conduct of the clinical trial for AMR-001, while enabling Amorcyte to pursue other potential related product development opportunities," said President of Progenitor Cell Therapy, Dr. Robert Preti.
AMR-001 is an autologous bone marrow-derived cell product being tested to determine if its infusion into the coronary (heart) artery after myocardial infarct can restore heart muscle function in tissue damaged by the heart attack. Forty men and women who have had a recent heart attack and meet criteria will be asked to take part in this study.
The Phase I trial is now open at Emory University School of Medicine under Principal Investigator, Arshed A. Quyyumi, M.D., FRCP, FACC. Amorcyte is in final negotiations to open the trial in another leading cardiology center within 90 days. Amorcyte is actively recruiting patients for the trial.
About Cardiovascular Disease
It is estimated there are approximately 1.1 million instances of acute myocardial infarction, 12 million cases of chronic ischemia, and 5 million occurrences of congestive heart failure in the United States per year. A significant percentage of these patients are in need of additional therapies to ameliorate the symptoms of their disease. Products like AMR-001 are now under active investigation to determine safety and potential biologic activity.
About Amorcyte Inc
Amorcyte Inc is a therapeutics company pursuing cell based therapies for cardiovascular diseases, reimbursable on a commercial scale for widespread clinical use. Amorcyte was incorporated in May 2005 and received FDA approval for its Phase I trial IND in September 2005. Watch for the launch of www.amorcyte.com coming soon.
Source: Business Wire
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