PSTI announced (4/26/10) interim results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (NYSE:CLI), the end-stage of peripheral artery disease (PAD).
A total of 21 patients, representing 77% of the cohorts required to complete the Phase I dose-escalating studies in the US and Germany have been dosed with PLX-PAD. This includes 15 patients dosed in Germany, representing the complete patient enrollment in that country.
- The interim data demonstrated that PLX-PAD was safe, well tolerated and effective.These Phase I studies were designed to evaluate the safety of PLX-PAD in patients with CLI,
- Both trials have currently met their primary safety endpoints,
- The administration of PLX-PAD cells did not induce an immune response in any of the patients dosed; demonstrating that injection of PLX-PAD cells is well tolerated,
- 12 of the 21 patients dosed completed their 3 month follow-up.
PSTI also announced that it had entered into agreement with selected investors to sell restricted common (not registered) stock and warrants for aggregate gross proceeds of approximately $2.7 M.
- The offering includes 2,420,293 shares of common stock, warrants purchasing 726,088 shares of common stock at an exercise price of $1.25 per share and warrants to purchase 726,088 shares of common stock at an exercise price of $1.40 per share,
- The warrants will be exercisable for a period of 2 ½ years and 5 years respectively commencing 6 months following the issuance. The closing is scheduled to take place on 4/27/10.