ReleaseWire Connect

Scarsdale resident, Karine Kleinhaus, M.D., M.P.H., VP, North America, for Pluristem Therapeutics (NASDAQ: PSTI), will be an hour long live radio guest on Peter Moses's radio show on WVOX 1460 AM in Westchester, NY and streaming live at wvox.com, this Monday, June 1, 2015 from 3-4 pm E.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) agreed with the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This agreement is an important milestone for initiation of a Phase I/II study in critical limb ischemia through Japan's Accelerated Pathway for Regenerative Medicine. The new regulatory pathway could potentially significantly reduce time to market for cell therapies such as PLX cells.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today strong positive data from a preclinical study of PLX-R18 cells to improve outcomes of bone marrow transplantation. In the study, conducted in conjunction with Hadassah Medical Center's Department of Bone Marrow Transplantation and Cancer Immunotherapy, mice with damaged bone marrow who received intramuscular injections of PLX-R18 cells together with a bone marrow transplant had significantly faster recovery of blood cell production compared to those who received a placebo with the bone marrow transplant. A rapid return to normal blood cell counts is critical for people who require a transplant to replace dysfunctional bone marrow because of diseases such as leukemia or other blood cancers. PLX-R18, Pluristem's second product, is being developed to treat a range of hematologic indications including bone marrow deficiency and complications of bone marrow and umbilical cord blood transplantation.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today the positive results of a recently completed trial conducted by the U.S. National Institutes of Health (NIH) to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation. The data also suggested that the treatment may potentially be able to shorten time to recovery.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced an important new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA). Data showed that six months after surgery the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant (19.4 vs 0.5 Nm, p=0.0114). Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo (9.48 vs 0.46 Nm, p=0.227).

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today that it has been issued Patent No. 2013/07160, titled "Methods and Systems for Harvesting Adherent Stromal Cells", in South Africa. This patent addresses Pluristem's methods for using vibration to harvest cells grown on three-dimensional scaffolds, the harvested cells themselves, and devices developed for this process. The lack of an effective technology for harvesting live cells from these carriers was a longstanding roadblock to three-dimensional growth of cell therapy products.

New findings suggest that placental cells may potentially treat damaged nerves possibly leading the way to new treatment for stroke patients.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today it has been granted a patent in Singapore titled "Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy."

Pluristem Therapeutics Inc., a leading developer of placenta-derived cell therapy products, announced today that researchers at Case Western Reserve University will conduct a preclinical study of the Company's PLacental eXpanded (PLX)-RAD cells. The study will evaluate whether PLX-RAD cells increase the success rate of human umbilical cord blood transplantation.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel's Ministry of Health and follows similar clearances from the U.S. Food and Drug Administration, the European Union 's Qualified Person, Germany 's Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.