Pluristem Presents Final PLX-PAD Efficacy Data Supporting Upcoming IND Submission to the U.S. FDA
NEW YORK--(BUSINESS WIRE)--Sept. 16, 2008 - Pluristem Therapeutics Inc. (Nasdaq:PSTI)(DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today the successful conclusion of its pre-clinical efficacy studies utilizing PLX-PAD prior to the initiation of human clinical trials. PLX-PAD is Pluristem's cellular product for the treatment of critical limb ischemia (CLI), the end stage of Peripheral Artery Disease (PAD).
The final efficacy studies involved 110 animals whose hind legs were rendered ischemic (reduction in blood flow) using standard industry methodologies. The animals received intra-muscular (IM) injections of six different batches of PLX-PAD or a control substance at two separate sites in the ischemic limb then followed for up to 30 days post-injection. At the end of the study period, those animals receiving PLX-PAD had a statistically significant increase in blood flow, angiogenesis (new blood vessel growth) and functionality. In addition, those animals receiving PLX-PAD had an absence of necrosis (tissue loss) in the affected limb compared to several instances of necrosis in the control animals. These studies confirm results of trials previously performed in proof-of-concept studies using PLX-PAD.
Zami Aberman, Pluristem's President and CEO commented, "These final PLX-PAD efficacy studies show impressive new vessel formation and may bring hope to millions of people suffering from complications of diabetes, Buerger's Disease and smoking where insufficient blood flow to their lower legs places them at risk of amputation. The successful completion of the PLX-PAD pre-clinical efficacy trials, in accordance with the regulatory authority's requirements, validates the results we obtained in our previous studies with this product and gives us assurances that allogeneic adherent stromal cells will be efficacious for this disorder. This was our final pre-clinical efficacy study using PLX-PAD and we now intend to commence human trials, following receipt of the necessary regulatory approvals."
About Critical Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with PAD. The disease is characterized by narrowing and hardening of the arteries in the patient's limb(s) caused and/or aggravated by diabetes, Buerger's Disease, other diseases and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications. Industry experts have estimated that the market for therapeutics used in the treatment of limb ischemia to be over $1 Billion. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led the medical community to call for the development of cellular therapies, such as Pluristem's PLX-PAD, as alternative treatments.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriX(TM) 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells' efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and possess immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company's products in development also include PLX-IBD, targeting Inflammatory Bowel Disease (IBD); PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
See our product animation on YouTube: http://www.youtube.com/watch?v=QzAANdeg0b0, the content of which is not part of this press release.
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 say that PLX-PAD could become an effective therapeutic alternative for diabetics, smokers and others who are at risk of amputation, or that these final PLX-PAD efficacy studies show impressive new vessel formation and may bring hope to millions of people suffering from complications of diabetes, Buerger's Disease and smoking where insufficient blood flow to their lower legs places them at risk of amputation, or that the successful completion of the PLX-PAD pre-clinical efficacy trials, in accordance with the regulatory authority's requirements, validates the results we obtained in our previous studies with this product and gives us assurances that allogeneic adherent stromal cells will be efficacious for this disorder, or that this was our final pre-clinical efficacy study using PLX-PAD and we now intend to commence human trials, following receipt of the necessary regulatory approvals, we are using forward-looking statements. These forward-looking statements 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: failure to obtain required regulatory approvals, changes in technology and market requirements; 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; results in the laboratory may not translate to equally good results in real surgical settings; 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 risk and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
Pluristem Investor Contact:
William Prather RPh, MD, 303-883-4954
Sr. VP Corporate Development
Posted: September 2008