Pluristem’s PLX-PAD holds promise for critical limb ischemia

PluristemNov 18 2009

Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) today announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

The first patient was treated with the lowest of three doses and has completed the three month follow up with the following results:

• The patient’s Rutherford Category (a scale of the severity of a patient’s limb ischemia) decreased by 50 percent.
• The patient has reported that the ability to walk pain free increased from 20 meters (approximately 60 feet) to 120 meters (approximately 360 feet), representing a 500 percent improvement over baseline.

In addition, the patient’s VascuQol score (quality of life score), VAS score (pain score), and the hemodynamic parameters, ankle-brachial index, toe-brachial index, and transcutaneous oxygen pressure, improved compared to baseline.

Based on the decrease in the patient’s Rutherford Category, Pluristem believes that the patient may no longer fulfill the criteria for the diagnosis of critical limb ischemia.

Professor Doctor André Schmidt-Lucke, Director of the Franziskus-Krankenhaus Institute of Berlin, Germany and Project Leader of the PLX-PAD clinical trial stated, “Although we are early in the clinical trial, Pluristem’s PLX-PAD product could represent a significant advancement towards finding an efficacious therapy for critical limb ischemia.”

“These results are the first indication of the safety and efficacy of the treatment with PLX-PAD,” said Zami Aberman, chairman and CEO of Pluristem. “Although these results may not be entirely reproducible in other patients, we are encouraged that the first patient ever to receive our PLX-PAD cells in the lowest of the three doses has exhibited data to suggest our product candidate is safe and potentially efficacious.”