Backed by the promising outcome of an early-stage study of its stem cell therapy for improving arterial blood flow, Israel's Pluristem Technology is laying the groundwork for a Phase II now scheduled to launch next year.
In a small study of 21 patients with critical limb ischemia, PLX-PAD sailed through without any serious side effects reported. There were no negative immune responses registered and half of the 12 patients tested at a three-month follow-up demonstrated improvements in two of three key efficacy measurements. Four of the patients demonstrated an improvement in blood flow for the ankle and toe as well as an improvement in the measurement of oxygen below the skin.
"We did not expect to see any real or significant efficacy results and we have seen the results," Pluristem Chief Executive Zami Aberman told Reuters. In a separate announcement out this morning Pluristem said that it has raised $2.7 million through a private placement.
The positive outcome will pave the way to a Phase II study which Pluristem is now planning for the third quarter of 2011. PLX-PAD is provided to patients in 30 to 50 localized injections in the patients' muscles, rather than through infusion. It is created by culturing stem cells extracted from a placenta. The developer believes that PLX-PAD could be beneficial for a number of conditions.
"The majority of the patients treated reported an improvement in their quality of life and objective efficacy parameters," said Professor Doctor Andre Schmidt-Lucke, director of the Franziskus-Krankenhaus Institute of Berlin, Germany, and the leading study physician of the German trial.
- see the release on the trial results
- here's the Reuters story on the data
- and here's the release on the private placement