ASTM NEWS - Aastrom Announces First Patient Treatment With Autologous Stem Cell Therapy for Heart Failure
Tuesday January 15, 1:00 pm ET
Company Milestone Achieved by Initiating Treatments in Heart Failure Patients With Dilated Cardiomyopathy -- a Severe Chronic Disease of the Heart
ANN ARBOR, Mich., Jan. 15, 2008 (PRIME NEWSWIRE) -- Aastrom Biosciences, Inc. (NasdaqCM:ASTM - News), a leading regenerative medicine company, today announced that the first patient has been treated with the Company's autologous stem cell therapy for dilated cardiomyopathy (DCM). The milestone marks the first human application of Aastrom's Cardiac Repair Cell (CRC) product to regenerate damaged heart tissue in patients with severely impaired cardiac function.
CRCs are derived from a small sample of a patient's bone marrow that is processed using Aastrom's proprietary Tissue Repair Cell (TRC) technology to generate large numbers of stem and early progenitor cells. Near the end of 2007, the first patient was treated with CRCs in a European compassionate-use case. Cells were administered to the patient via direct injection into the heart muscle. The use of CRCs in patients is ongoing and Aastrom intends to establish treatment for additional DCM patients in several leading European heart centers. It is anticipated that clinical data from the compassionate-use cases will be available during 2008.
``We are very pleased to have successfully achieved this important milestone, and look forward to continuing our development program focused on this promising therapy for the treatment of patients with dilated cardiomyopathy,'' said George Dunbar, President and Chief Executive Officer of Aastrom. ``During 2008, we expect to make significant clinical progress in our cardiac regeneration program and to begin to report clinical results.''
It is expected that the compassionate-use of CRCs will provide useful experience for the development of clinical protocols in future regulatory submissions targeting DCM. In February 2007, Aastrom's proprietary CRCs received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for use in the treatment of DCM. In the U.S., Orphan Drug Designation provides a variety of incentives, including seven years of market exclusivity following FDA approval.
In addition to initiating treatment in patients with dilated cardiomyopathy, Aastrom also has development programs using TRC-based products for vascular, bone and neural tissue regeneration applications. The Company recently reported positive interim results from a German Phase I/II trial utilizing Vascular Repair Cells (VRCs) to treat diabetic patients with critical limb ischemia (CLI), the most severe form of peripheral arterial disease. Also reported were positive early data from a German compassionate-use study evaluating the use of Bone Repair Cells (BRCs) to treat patients suffering from osteonecrosis of the femoral head.
Just my opinion...
