PLRS,
Pluristem Expects to Submit Pre-IND Document to FDA by End of 2006
Tuesday October 31, 7:30 am ET
HAIFA, Israel--(BUSINESS WIRE)--Pluristem Life Systems, Inc. (OTCBB: PLRS - News), a cell therapy company dedicated to the commercialization of stem cell products, today announced that it expects to submit the Pre-Investigational New Drug (Pre-IND) document describing the suggested clinical trial and the preclinical data to the FDA by the end of the 4th quarter Of 2006. Approval of the Pre-IND by the FDA precedes initiation of Phase I trials.
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Pluristem recently presented a Pre-Pre-IND to the Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies, a department in the Food and Drug Administration (FDA). The Pre-Pre-IND documented the final results of an animal model study using the Company's innovative adjuvant cell therapy product based on PLacenta eXpanded Mesenchymal cells (PLX-I).
In the Pre-Pre-IND conference call following the submission of the document, the FDA team of experts and the Pluristem FDA team discussed the proposed structure of the clinical trial, and the pre-clinical data required to approve the initiation of Phase I clinical trials of PLX-I. The FDA and Pluristem agreed that the proposed structure of Pluristem's Phase I study should document the safe use of PLX-I cells when combined with Umbilical Cord Blood (UCB), and how the combination could improve the treatment of blood disorders.
In the upcoming Pre-IND filing, Pluristem will present to the FDA CBER team the results of an additional agreed upon pre-clinical Animal trial. This additional pre-clinical animal trial will be performed on immune-deficient irradiated NOD-SCID mice which will be co-implanted with un-purified human umbilical cord blood cells and PLX-I. The conclusions will be held in comparison to Pluristem's published Pre-clinical results that used CD34+ purified from human umbilical cord blood cells. This additional trial will determine the final structure of the pre-clinical data required for FDA approval of the IND application.
Mr. Zami Aberman, Pluristem CEO, stated: "We would like to thank the CBER team for the very productive discussion. We expect to demonstrate that the co-transplantation of PLX-I cell types are a promising manipulation that improves cord blood performance during the replacement of bone marrow transplants in adults. I believe that this new pre-clinical animal trial will help to finalize the required pre-clinical studies prior to moving to Phase I trials."
About Pluristem
Pluristem Life Systems, Inc. is a life sciences driven company that is developing and commercializing stem cell expansion technology products for the treatment of severe blood disorders. 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.
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