Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade PSTI now with 

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

Quick Facts

Editors Pick
Specialty drugmaker Horizon Pharma plc (HZNP) on Friday managed to redomicile itself as an entity incorporated in Ireland following the completion of its $660 million acquisition of Vidara Therapeutics International plc. The deal will help it avoid paying the high rate of U.S. corporate taxes. The... Stocks showed a lack of direction over the course of the trading day on Friday after failing to sustain an initial upward move. Despite the choppy trading, the Dow once again managed to end the session at a new record closing high. The major averages turned in a mixed performance on the day. President Barack Obama delivered a statement Thursday evening thanking members of Congress for voting to approve legislation granting the U.S. military the authority to train and arm moderate Syrian rebels fighting against the terrorist group known as the Islamic State.
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.