Aastrom Biosciences (NASDAQ: ASTM) announces initiation of patient enrollment in REVIVE phase III trial of Ixmyelocel-T ($1.79):
- ASTM has begun patient enrollment in the REVIVE Phase 3 clinical trial to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with critical limb ischemia (CLI).
- The primary endpoint of the trial will be amputation-free survival at 12 months.
- The REVIVE clinical trial has also been granted Fast Track designation by the FDA.
Daily Dose Conclusion: This is positive as the trial gets underway. Investors are concerned that the lack of a partner means Aastrom has to fund this trial alone, which will be expensive. The likely conclusion then is that Aastrom will need to raise additional capital. At this valuation however a good amount of that is likely factored into he share price. Other earlier players in CLI include Pluristem (PSTI), and Cytomedix - Aldagen (CMXI). We have also recently written on Thermogenesis (KOOL) working in the CLI space.