By GlobeNewswire, October 02, 2013, 04:00:00 AM EDT
International Study Extends FDA Phase II Trial That Began in U.S.
HAIFA, Israel, Oct. 2, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq: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
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we discuss our study in Israel and say that the professional review of the clinical trial application by the Israeli Ministry of Health will provide a solid foundation for us to conduct additional studies in Israel, we are using forward-looking statements. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
CONTACT: Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
Investor & Media Relations Director
Source: Pluristem Therapeutics Inc.