Re: NEWS OCT 2:PSTI receives Israeli Ministry of Health approval 2nd phase trial
posted on
Oct 03, 2013 08:58AM
Adult stem cell development company commencing clinical trials applicable to estimated $30 billion degenerative disease market place
Thanks emma, things looking good. You've got 4 thumbs up so far....You are so dedicatated, thank you! I think that is a record for this PSTI board. If it's not a record of all time, I haven't seen 4 thumbs up for a very long time. We are gaining more interest because PSTI is on the move. GLTAL Here's the copy/paste:
HAIFA, Israel, Oct. 2, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the Israeli Ministry of Health has approved the company's request to initiate a Phase II study using its PLacental eXpanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). This approval is part of the company's previously announced strategy to conduct a multi-national study for this indication. The protocol will be the same one used for the study previously approved in the U.S.
Zami Aberman, Chairman and CEO of Pluristem stated, "We are excited to receive the Ministry of Health approval for our clinical study in Israel. This also marks the first clinical study in Israel to use off-the-shelf allogeneic, placental-derived cells. Additionally, the professional review of this clinical trial application by the Israeli Ministry of Health will provide a solid foundation for Pluristem to conduct additional studies in Israel."
About the Study
Pluristem's IC Phase II is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is comprised of approximately 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.
The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
About Intermittent Claudication
IC is a subset of PAD caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue classically in the calf muscle, which occurs during exercise, such as walking, and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients and representing a cost of approximately $2.5 billion annually to the National Healthcare Bill (References:The SAGE Group and HCUP 2007 Inpatient Data).
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
The Pluristem Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6882