logo
Share SHARE
FONT-SIZE Plus   Neg

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

Pluristem Therapeutics Inc. (PSTI) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Major League Baseball is talking expansion for the first time in a few decades. Owners stand to make a pretty penny from expansion fees and subsequent television rights. The possibility of a more balanced schedule is also enticing. Strong expansion candidates in the U.S. and Canada are ready... The New York Times is teaming up with Google again to give away Google Cardboard, the virtual reality headsets, but this time only to its "most loyal" digital subscribers. The company said that the digital-only subscribers selected for this distribution were chosen based on the duration of their subscriptions. Oil company Exxon Mobil Corp. on Friday reported a 63 percent fall in profit for the first quarter from last year, while Chevron Corp. reported a loss for the quarter, both on lower revenues. The results were impacted by the fall in crude oil prices and weaker refining margins. However, Exxon Mobil's earnings beat analysts' estimates, while Chevron's loss was wider than their expectations.
comments powered by Disqus
Follow RTT