Pluristem Successfully Concludes Final Pre-Clinical Safety Studies with PLX-PAD in Preparation for Human Trials
NEW YORK--(BUSINESS WIRE)--Sep 10, 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 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 phase of Peripheral Artery Disease (PAD).
The final studies involved 150 animals that received single, repeated intra-muscular (IM) injections of PLX-PAD or a control substance then followed for up to 3 months post-injection. No adverse effects were noted to be caused by the PLX-PAD injections throughout the study period. Moreover, all the histology, hematology and biochemistry panels and biodistribution results support the safe administration of PLX-PAD.
Previously, the Company had reported that in animals whose hind legs were rendered ischemic (reduction in blood flow) using standard industry methodologies, post-treatment evaluation using laser Doppler technology indicated revascularization (return of blood flow) of the limbs treated with PLX-PAD but not in those limbs not treated with PLX-PAD. The affected limbs' function also improved in those animals receiving PLX-PAD. Additionally, microscopic analyses of those limbs treated with PLX-PAD indicated a statistically significant increase in the number of new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the ability to promote angiogenesis (new vessel formation).
Zami Aberman, Pluristem's President and CEO commented, "The successful completion of the PLX-PAD pre-clinical phase, in accordance with the regulatory authority's requirements, is a major milestone. This was our final study using our PLX-PAD. We now intend to commence human trials, following receipt of the required regulatory approvals. The impressive results we have obtained in these studies give us confidence that we will be able to prove safety in our planned US and European dose escalation Phase I/II human studies, followed by proof of efficacy in our later trials."
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.
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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 this was our final study using our PLX-PAD; that we now intend to commence human trials, following receipt of the required regulatory approvals and that the impressive results we have obtained in these studies give us confidence that we will be able to prove safety in our planned US and European dose escalation Phase I/II human studies, followed by proof of efficacy in our later trials, 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 Therapeutics Inc.
William Prather RPh, MD, 303-883-4954 (Investors)
Sr. VP Corporate Development
Posted: September 2008