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PLRS News Pluristem Submits Pre-Investigational New Drug Document to FDA

NEW YORK--(BUSINESS WIRE)--Pluristem Life Systems, Inc. (OTCBB:PLRS), a cell therapy company dedicated to the commercialization of stem cell products, today announced that it has submitted a Pre-Investigational New Drug (Pre-IND) document to the Food and Drug Administration (FDA) for PLX-I, the Company’s first product. An innovative adjuvant cell therapy product based on PLacenta eXpanded Mesenchymal cells, PLX- I is expected to be used to improve the engraftment of Umbilical Cord Blood when treating blood cancer and blood disorders. Approval of the Pre-IND document by the FDA precedes initiation of Phase I trials.

Pluristem has submitted the Pre-IND document to the Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, a department in the FDA. The document contains the results of additional animal model studies requested since the filing of a Pre-Pre-IND document and subsequent conference call with the FDA. The additional animal model studies’ data will support Pluristem’s recommendation as to the final structure of the Pre-Clinical animal study for an IND submission planned for later this year. The Pre-IND document also contains information concerning the process used to manufacture Pluristem’s PLX-I product and the proposed clinical trial supporting the Company’s IND.

Mr. Zami Aberman, Pluristem CEO, stated: “I am proud that our Pluristem team has accomplished this important milestone, submitting the Pre-IND document as planned. I believe it represents the team’s ability and devotion to successfully meet the Company’s targets and milestones, leading the company for future achievements and prosperity for the benefit our valued shareholders."

About Pluristem

Pluristem Life Systems, Inc. is a life sciences Company whose goal is to develop and commercialize stem cell expansion technology products for the treatment of several debilitating diseases. The Company is discovering and developing cell-based therapeutics that utilizes adult stem cells expanded in a proprietary bioreactor mimicking different naturally occurring physiological environments. Pluristem expects its first products to be cell grafts that will provide an efficient and superior alternative to the standard procedure of bone marrow transplantation. Its first adult stem cell product targets a critical global shortfall of matched tissue for bone marrow transplantation since bone marrow transplantation is often the only cure for patients suffering from leukemia, lymphoma, myeloma and many other hematological diseases. The Company has made a strategic decision to work only with adult stem cells since the practical use of embryonic stem cells is severely restricted by various religious, ethical and legal considerations.

www.pluristem.com

Safe Harbor Statement

This press release contains statements, which may constitute "forward-looking statements" regarding our intent, belief or current expectations. Forward-looking statements in this release include that: the new animal data is to support Pluristem’s recommendation to the FDA as to the final structure of the Pre Clinical animal study that will support our Investigational New Drug (IND) submission planned for this year; that the IND will investigate the ability of the Company's proprietary, innovative adjuvant stem cell therapy product; and how the combination therapy could improve the treatment of blood disorders; that our ability to meet our milestone targets will build our investor’s confidence; the Company is discovering and developing cell-based therapeutics that utilizes adult stem cells expanded in a proprietary bioreactor mimicking different naturally occurring physiological environments, Pluristem expects its first products to be cell grafts that will provide an efficient and superior alternative to the standard procedure of bone marrow transplantation. Its first adult stem cell product is intended to target a critical global shortfall of matched tissue for bone marrow transplantation since bone marrow transplantation is often the only cure for patients suffering from leukemia, lymphoma, myeloma and many other hematological diseases. Factors which may significantly change or prevent our forward looking statements from fruition include that we may be unsuccessful in developing any products; that our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; that we are unable to retain or attract key employees whose knowledge is essential to the development of our products; that unforeseen scientific difficulties develop with our process; that results in the laboratory do not translate to equally good results in real surgical settings and our research does not accomplish what we expect; that our patents are not sufficient to protect essential aspects of our technology; that competitors may invent better technology; that our products may not work as well as hoped or worse, that our products may harm recipients; and that we may not be able raise funds for development or working capital when we require it. As well, our products may never develop into useful products and even if they do, they may not be approved for sale to the public. For further risk factors see the Company's latest 10-KSB filed with the SEC.