Aastrom Biosciences (ASTM) Initiates of Patient Enrollment in REVIVE P3 Clinical Trial of Ixmyelocel-T
The primary endpoint of the trial will be amputation-free survival at 12 months. REVIVE is the largest randomized, double-blind, placebo-controlled, multicenter study ever conducted in patients with CLI.
- The P3 trial will be conducted at 80 sites in the US and will include 594 CLI patients who have no option for revascularization and also have existing tissue loss due to ischemia;
- Patients will be followed for a total of 18 months, including 12 months from randomization for efficacy and an additional 6 months for safety;
- This REVIVE clinical trial is supported by an independent steering committee of renowned leaders in vascular medicine and clinical research who will provide independent oversight as well as medical and clinical guidance;
- ASTM reached final agreement on a Special Protocol Assessment (SPA) from the FDA for the P3 study.
The REVIVE clinical trial has also been granted Fast Track designation by the FDA.
The Bottom Line: The initiation of this study is the result of extensive interactions with the FDA in a Special Protocol Assessment review process designed to ensure the integrity of both the cellular therapy product and the clinical trial to evaluate Ixmyelocel-T as a therapy for a critically ill patient population. From yesterday … Interesting comparable …PSTI has made the strategic decision to … use only commercial-grade PLX cells for their P2/3 pivotal clinical trial. Their cells will be manufactured in their new facility <scheduled to be completed towards the end of 2012 and when approved by the FDA>. PSTI will then … file the necessary documentation with the US, FDA and European Medicines Agency (EMA) and upon regulatory approval … to begin this important trial. ANOTHER INDICATION …that PSTI is … holding back on a CLI indication trial … leaving Aastrom (ASTM) to the …. leading position for a CLI therapeutic!