Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Clears Pluristem's Phase II Clinical Trial In Intermittent Claudication

Pluristem Therapeutics Inc. (PSTI: Quote) announced that the United States Food and Drug Administration or FDA has granted the company clearance to start a Phase II clinical trial using the company's PLX-PAD cell product candidate for the treatment of Intermittent Claudication or IC, a subset of peripheral artery disease or PAD.

Pluristem's IC Phase II trial will evaluate the safety and efficacy of two doses (150x106 and 300x106) of PLX-PAD cells versus placebo administered via two intramuscular injections (day one and week twelve post initial injection).

The company noted that the study population will be comprised of 132 patients (44 in each cohort) with IC, Fontaine class IIb; Rutherford category 2-3, in approximately 10 U.S. clinical sites.

The primary efficacy end point of the trial will be the change in the Maximal Walking Distance from baseline during an Exercise Treadmill Test. Secondary endpoints will include hemodynamics and quality of life measurements. Safety parameters will also be assessed.

Click here to receive FREE breaking news email alerts for Pluristem Therapeutics, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
A number of major retailers will be open on Thanksgiving for early Black Friday shopping events. Kohl's department stores will kick off Black Friday sales two hours earlier this year, at 6 p.m. Thanksgiving Day, while Macy's, Bon-Ton and Best Buy will open at the same time. J.C. Penney and Sears... Twitter Inc. has replaced its head of product Daniel Graf just six months after luring him over from Google, according to multiple reports. Graf, previously known for his work leading Google Maps, will retain his vice president of product title and work on Twitter's geolocation features, the Wall... LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its third quarter loss widened slightly from last year, as higher costs and expenses more than offset a 45% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.