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. Approval of the Pre-IND by the FDA precedes initiation of Phase I trials.
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.”
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