Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that following its meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority for advanced therapy products (ATP), the company is advancing toward designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia (CLI) and Moderate-severe Claudication.
The company has also received approval for a government grant in the amount of $2.5 million from the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor of Israel, as government participation in R&D expenses for the period March 2010 to February 2011. This is the fifth consecutive year that Pluristem has received this grant.
Two Phase IIb studies will further evaluate the safety and efficacy of PLX-PAD in patients suffering from CLI, the end stage of peripheral artery disease (PAD), and Moderate-severe Claudication. In the U.S., there is a significant unmet medical need for an effective and economical treatment for both conditions, which have an estimated national cost of $14.3 billion annually, based on inpatient hospital bills.
“The rapid advancement of PLX-PAD through clinical trials may allow us to bring to the market a cost-effective treatment for CLI and Moderate-severe Claudication as well as to help relieve the large economic burden currently sustained in treating these disorders,” said Zami Aberman, Pluristem’s chairman and CEO. “Additionally, we are pleased yet again to receive the prestigious Israeli government award to support our novel drug delivery therapy. We will use this grant to accelerate the progress toward our Phase IIb clinical trials.”About PAD Approximately 12 million people in the U.S. suffer from limb ischemia associated with PAD. The economic impact of this growing burden of patients afflicted with PAD is being experienced acutely in the United States with approximately $14.3 billion annually in national inpatient bills for the treatment of PAD and $10.2 billion annually in national inpatient bills for the treatment of CLI. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led to the medical community’s call for the development of cell therapies, such as Pluristem’s PLX-PAD, as alternative and potentially cost-effective treatments.