| 01 Mars 2011
Positive Pre-Clinical Data From Muscle Injury Study Moves Pluristem Toward Second Multi-Billion Dollar Clinical Indication
Research Conducted at Berlin-Brandenburg Center for Regenerative Therapies and Charite University of Medicine Offers New Potentially Promising Cell Treatment for the Muscle Injury Market
HAIFA , Israel , March 1, 2011 -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) and the Berlin-Brandenburg Center for Regenerative Therapies (BCRT), in cooperation with the Charite - University of Medicine in Berlin,today announced the results of a pre-clinical study demonstrating that the local administration of PLX cells following muscle injury resulted in significant improvement in the recovery of muscle function when compared with the control group. This study suggests that Pluristem's PLX cells have the potential to treat both accidental and intentionally induced muscle injuries.
Subject to regulatory approval, Pluristem plans on moving ahead with clinical trials for muscle injury indications. These trials will be conducted in addition to the anticipated Phase II/III trial using PLX-PAD for the treatment of Critical Limb Ischemia.
The data from the study indicates that PLX cells can be used in several categories of muscle injury, including accidental injuries, such as those incurred during athletic activity, as well as intentional injuries, such as after the incision of a skeletal muscle during surgery. These markets represent a potential annual market of approximately 10 Billion USD.
During the study, either immediately or seven days after delivering injury to the soleus muscle, PLX cells or saline were injected into the traumatized muscles. Four weeks after administration, the regenerative capacity of the soleus muscle was measured bilaterally by stimulating the sciatic nerve. PLX cell administration resulted in a significant improvement in the recovery of function of the involved muscles.
"This is a landmark study because it is the first to show significant improvement of muscle injuries through the use of placental derived allogenic therapies," said Prof. Dr. Georg N. Duda, head of the Julius Wolff Institute, co-head of the BCRT and principal investigator for the study. "The study demonstrates the great potential that Pluristem's PLX cells hold for treating such injuries and we look forward to continuing to research this application and investigate its positive effects even further."
Prof. Dr. Carsten Perka, head of orthopedics at the Center for Musculoskeletal Surgery at the Charite, emphasized the clinical need for this study: "A major problem for surgeons, especially in endoprosthetics, is muscular deficiencies, in particular muscular atrophy. Therefore, the approach of using PLX cells as adjuvant therapy to an orthopedic surgery is a unique opportunity to improve the healing outcome of patients."
Based on the pre-clinical studies, Pluristem has initiated discussions with the Paul Ehrlich Institute (PEI), the German competent authority, for a clinical development plan in which PLX cells will be used as an adjuvant therapy for the recovery of muscle function following hip replacement surgery.
"The successful completion of these pre-clinical studies is very exciting for Pluristem, as it opens an additional, and potentially very lucrative, product candidate in our PLX platform pipeline," said Zami Aberman, Chairman, President and CEO of Pluristem. "We are very encouraged by the findings of the Berlin-Brandenburg Center for Regenerative Therapies and look forward to moving ahead with the next stage of clinical research."
# # #
About Berlin-Brandenburg Center for Regenerative Therapies (BCRT)
The BCRT has a highly interactive research program based on a consortium of internationally acknowledged experts in both basic and clinical science - with a track record of successful scientific interaction, demonstrated by numerous joint publications in high-ranking journals and joint network projects (DFG, BMBF, EU etc.). The program comprises work in three medical research fields linked to overlapping platforms on basic, biomaterials, and translational research. The center places emphasis on research and clinical programs related to musculoskeletal, immunological and cardiovascular applications, since these aspects of regenerative medicine are most advanced at the Charite and are closest to clinical translation. Partnerships have already been established with several companies, including Milteny Biotech, BBraun, Pharmicell Europe and Pluristem. For more information visit http://bcrt.charite.de/
The Berlin-Branenburg Center for Regenerative Therapies logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8821
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory 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 or immune-suppression treatment prior to administration. The PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20 million patients in the Peripheral Artery Disease (PAD) market.
Data from two Phase I clinical trials indicate that Pluristem's first PLX product, PLX-PAD, is safe and potentially effective for the treatment of end stage PAD. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage when administered locally and in inflammatory bowel disease, MS and stroke when administered systemically.
Pluristem has a strong patent portfolio, 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. Follow Pluristem on Twitter @Pluristem.
CLICK HERE to watch a video where CLI patients and doctors involved with the clinical trials share their stories. CLICK HERE to see Pluristem's cell therapy product animation on YouTube.
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, we are using forward looking statements when we discuss the research conducted at Berlin-Brandenburg Center for Regenerative Therapies and Charité University of Medicine and say that it offers new potentially promising cell treatment for Muscle Injury Market, or that our PLX cells have the potential to treat both accidental and intentionally induced muscle injuries, or that subject to regulatory approval, we plan on moving ahead with clinical trials for the muscle injury indication, or that the data from the study indicates that PLX cells may be used in several categories of muscle injury, including accidental injuries, such as those incurred during athletic activity, as well as intentional injuries, such as after the incision of a skeletal muscle during surgery and that these markets represent a potential annual market of approximately 10 Billion USD. or when the said study is described as a landmark study and it is said that it demonstrates the potential that Pluristem's PLX cells hold for treating such injuries, or when it is said that the approach of using PLX cells as adjuvant therapy to an orthopedic surgery is a unique potential opportunity to improve the healing outcome of patients, or when we say that the successful completion of these pre-clinical studies potentially opens an additional, and potentially very lucrative, product candidate in our PLX platform pipeline, or that we look forward to moving ahead with the next stage of clinical research. 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: changes in technology and market requirements; we may encounter delays or obstacles in launching our clinical trials; 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; 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.
