logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
American Airlines Group said pilots at its subsidiaries American Airlines and US Airways, represented by Allied Pilots Association, have approved a new five-year contract which provides immediate pay raises of 23 percent and subsequent annual raises of three percent for the next five years. LEGO Group, TT Games and Warner Bros. Interactive Entertainment have announced their 2015 slate of video games, including LEGO Jurassic World, LEGO Marvel's Avengers, and as well as new hand-held and mobile titles. Social-networking giant Facebook, Inc. is said to be testing their new 'Place Tips' feature for iOS users that will rival a similar service being provided by Yelp or Foursquare. The feature will provide the user relevant content about their location as long as they are there through pop ups on their news feed page of Facebook.
comments powered by Disqus
RELATED NEWS
Trade PSTI now with 
Follow RTT