Pluristem Receives Approval to Initiate Phase II Study Using PLX-PAD Cells in Germany
Pluristem Therapeutics (NASDAQ: PSTI announced today that the Paul-Ehrlich-Institute (PEI), the medical regulatory body for biological medicinal products for the Federal Republic of Germany, has approved the company's request to initiate a Phase II study using PLX-PAD cells in patients suffering from Intermittent Claudication (IC). IC is a subset of Peripheral Artery Disease (PAD). According to The SAGE Group and HCUP 2007 Inpatient Data, the prevalence of IC in the United States is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the healthcare system.
"This approval is part of our previously announced strategy to conduct a multi-national study using our PLX-PAD cells in this disorder," said Zami Aberman, Chairman and CEO of Pluristem. "We are in the process of opening three clinical sites in Germany where the protocol will be same as the one used in the U.S. which has already begun enrolling and dosing patients. Additionally, we plan to expand into clinical sites in Israel, following regulatory approval."
About the Study
Pluristem's IC Phase II is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two doses