FDA Approves Aastrom Phase III IND for Treatment of Osteonecrosis of the Femoral Head

09-May-2007

Aastrom Biosciences, Inc. announced that the U.S. food & Drug Administration (FDA) approved the Company's Investigational New Drug (IND) application to initiate a 120 patient Phase III clinical trial for the treatment of osteonecrosis (also known as avascular necrosis) of the femoral head. Aastrom intends this to be a pivotal trial with the goal of demonstrating clinical safety and efficacy for the submission of a biologics License Application (BLA). In addition, the Company may have to generate further patient data in this indication, such as data from the ongoing pivotal trial in Spain, to support a U.S. BLA submission. Osteonecrosis is a progressive disease, with no established effective treatments, that often leads to a total hip replacement. Aastrom will use its Bone Repair Cell (BRC) product, based on Tissue Repair Cell (TRC) Technology, to evaluate this approach for treating patients suffering from osteonecrosis. Initiation of this clinical trial complements the receipt of an Orphan Drug Designation from the FDA.

The tissues involved in osteonecrosis of the femoral head include bone, bone marrow and blood vessels (vascular), complicating the development of effective treatments in the past. Aastrom's TRC-based products, which include a proprietary mixture of stem and progenitor cells derived from a small sample of the patient's own bone marrow, have been used in other clinical trials involving different indications to evaluate regeneration in all three of these tissues. With this capability, the application of TRC Technology may offer a novel means to regenerate the tissues lost due to osteonecrosis.

https://www.bionity.com/en/news/64494/fda-approves-aastrom-phase-iii-ind-for-treatment-of-osteonecrosis-of-the-femoral-head.html