patented technology to grow and expand adult Stem Cells

Adult stem cell development company commencing clinical trials applicable to estimated $30 billion degenerative disease market place

Free
Message: "the additional animal model studies' data will support Pluristem's" rec. + more

"the additional animal model studies' data will support Pluristem's" rec. + more

posted on Feb 19, 2008 03:01AM
PLX-1, cells mesenchymal stem cells (MSCs) obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX technology Trials: Hematological malignancies Current Trial Phase: 1 Trial Details: Pluristem Life Systems announced that the United States Food and Drug Administration's (FDA) Center for Biological Evaluation and Research (CBER) accepted the Company's proposed Pre-Investigation New Drug (PreIND) for its PLX-I product in preclinical studies for the treatment of hematological malignancies, 2/8/2007. Pluristem Life Systems 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-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, 1/4/2007. Medical Specialties: Oncology, Hematology Disease/ Condition Treated: leukemia Impending
Share
New Message
Please login to post a reply