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Pluristem Therapeutics, Inc. Message Board

  • allo.geneic allo.geneic Feb 14, 2013 11:13 PM Flag

    This Study Supports Pluristem's Technology Bigtime! And only Pluristem has the capability to produce their cells Globally on an Industrial Scale!

    February 14, 2013 06:45 PM Eastern Time

    Gamida Cell’s NiCord® Demonstrates Successful Engraftment in Patients with Hematological Malignancies in Phase I/II Study.

    Study results presented in an Oral Presentation at the 2013 BMT Tandem Meetings in Salt Lake City, Utah

    JERUSALEM--(BUSINESS WIRE)--Gamida Cell announced today the successful results of the Phase I/II study of its second pipeline product NiCord, umbilical cord derived stem cells expanded using the company’s proprietary NAM technology. Study data was announced today during an oral presentation titled Nicord® Expanded Hematopoietic Progenitor Cells (HPC) Are Capable of Outcompeting the Unmanipulated (UM) Cord Blood Unit and of Prolonged Myeloid and Lymphoid Engraftment Following Myeloablative Dual Umbilical Cord Blood (UCB) Transplantation. The presentation was delivered at the prestigious 2013 BMT Tandem Meetings in Salt Lake City by Dr. Mitchell E. Horwitz, associate professor of medicine at Duke Medicine and a principal investigator of the NiCord study for hematological malignancies (HM).

    “It is a sincere pleasure to work with the esteemed clinical team at Duke Medicine led by Dr. Horwitz and Dr. Joanne Kurtzberg. We look forward to continuing this very important research together.”
    .
    Eleven patients, ages 21-61, with high-risk hematological malignancies received NiCord and an un-manipulated graft of umbilical cord blood. Eight patients engrafted with NiCord. The median time to neutrophil engraftment was 10.5 (7-18) days for those engrafting with NiCord. Two patients engrafted with the un-manipulated UCB and one patient experienced primary graft failure. There were no cases of Grade III/IV acute GvHD. No safety concerns surrounding the use of NiCord were raised. With a median follow-up of 8 months, the progression-free and overall survival are both 90%.
    Dr. Horwitz said, “The results from this early study suggest that NiCord expanded hematopoietic progenitor cells (HPCs) reduce the time to hematopoietic recovery and are capable of long term ( 22 months) neutrophil and T-cell engraftment. Co-transplantation of NiCord and an un-manipulated cord blood unit is feasible and safe. Further studies are planned to confirm that the NiCord product can be transplanted as a single expanded unit, without co-infusion of un-manipulated cells. This would mean that only one cord blood unit would be used for transplantation, rather than two units, as are used today in most adult umbilical cord blood transplantations.”

    “We view NiCord as a paradigm shift in cord blood transplantation as this is the first technology that allows for durable engraftment of ex vivo expanded hematopoietic stem cells. It is also significant that NiCord engrafted unusually fast with apparent robust immune reconstitution,” said Dr. David Snyder, vice president of clinical development and regulatory affairs at Gamida Cell. “It is a sincere pleasure to work with the esteemed clinical team at Duke Medicine led by Dr. Horwitz and Dr. Joanne Kurtzberg. We look forward to continuing this very important research together.”

    Dr. Snyder continued, “Gamida Cell opted to begin clinical research of NiCord in hematological malignancies as cancer serves as a good bench mark. The early results of the HM study further supports the company’s ambitions to continue its initiative to develop NiCord for other indications including sickle cell disease, thalassemia, severe autoimmune diseases and genetic metabolic diseases. In fact, a phase I/II study is currently enrolling pediatric patients with sickle cell disease at Duke Medicine and at the Steven and Alexandra Cohen Children's Medical Center of New York

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    • This Primitive Teva Technology cannot hold a candle to Pluristem's Technology! In fact it is way-out in left field! No where near a competitor to Pluristem! Do Your Homework! This is laughable!

      NAM Based Technology
      NAM Platform Technology is Gamida Cell’s next generation platform technology. The lead molecule of this new technology is Nicotinamide (NAM), a form of vitamin B3 and a potent inhibitor of enzymes that use NAD as a co-factor for their activity. As such, NAM technology is linked to the redox state and metabolism of cells.

      NAM platform technology is now being applied to expand functional cells in culture, while attenuating the continuous morphological and functional alterations of cells during ex vivo cultures. The results of multiple studies using several animal models have demonstrated that the expanded cell grafts created using NAM technology displayed improved functionality following in vivo infusion, e.g. migration, homing, and durable retention in the target tissues. This noted, NAM technology is expected to increase the clinical efficacy of therapeutic cell products.

      Currently under pre-clinical and clinical development, NAM technology, and all related products, is an asset solely of Gamida Cell. (The rights of Teva and the Joint Venture are specific only to StemEx®). The products in development based on NAM technology are protected by a strong patent portfolio.

      Gamida Cell is now applying NAM technology to develop a pipeline of products including Nicord® for thalassemia sickle cell anemia, various hematological malignancies, severe autoimmune diseases and metabolic diseases and CordBridge™ for Neutropenia. The technology is also being applied to natural killer cells to develop therapies for metastatic solid tumors and refractory/relapsed hematological malignancies.

      NAM Based Technology
      NAM Platform Technology is Gamida Cell’s next generation platform technology. The lead molecule of this new technology is Nicotinamide (NAM), a form of vitamin B3 and a potent inhibitor of enzymes that use NAD as a co-factor for their activity. As such, NAM technology is linked to the redox state and metabolism of cells.

      NAM platform technology is now being applied to expand functional cells in culture, while attenuating the continuous morphological and functional alterations of cells during ex vivo cultures. The results of multiple studies using several animal models have demonstrated that the expanded cell grafts created using NAM technology displayed improved functionality following in vivo infusion, e.g. migration, homing, and durable retention in the target tissues. This noted, NAM technology is expected to increase the clinical efficacy of therapeutic cell products.

      Currently under pre-clinical and clinical development, NAM technology, and all related products, is an asset solely of Gamida Cell. (The rights of Teva and the Joint Venture are specific only to StemEx®). The products in development based on NAM technology are protected by a strong patent portfolio.

      Gamida Cell is now applying NAM technology to develop a pipeline of products including Nicord® for thalassemia sickle cell anemia, various hematological malignancies, severe autoimmune diseases and metabolic diseases and CordBridge™ for Neutropenia. The technology is also being applied to natural killer cells to develop therapies for metastatic solid tumors and refractory/relapsed hematological malignancies.

 
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