Pluristem links with Cato Research for PLX-PAD trial in IC indication in Europe

Israeli biotech company Pluristem Therapeutics (TASE: PLTR), a developer of placenta-based cell therapies, has selected Cato Research as its contract research organization (CRO) for the German portion of the company's Phase II trial in intermittent claudication (IC), a subset of peripheral artery disease (PAD), under the auspices of the Paul-Ehrlich Institute (PEI). PAD is a condition that is currently mainly treated with Sanofi and Bristol-Myers Squibb’s blockbuster blood thinner Plavix (clopidogrel), which is now facing generic competition.

Just last week, Pluristem received approval from the PEI, which is also a medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of its Placental eXpanded (PLX) cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement (The Pharma Letter August 8).

Cato will serve as Pluristem's applicant for its IC Clinical Trial Application to the PEI and to the ethics committees of the three study sites where the trials will be conducted. The trial will evaluate the safety and efficacy of Pluristem's PLacental eXpanded (PLX-PAD) cells in treating IC, a subset of peripheral artery disease (PAD). The prevalence of IC in the USA alone is around 14 million patients, representing a cost of about $2.5 billion annually to the health care system.