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Tuesday, 12/27/2016 6:01:28 AM

Tuesday, December 27, 2016 6:01:28 AM

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Pluristem and New York Blood Center to Collaborate in Evaluating PLX-R18 as an Adjuvant Therapy to Umbilical Cord Blood Transplantation, Winning $900,000 Funding From BIRD

Prior research has suggested that PLX-R18 helps cord blood cells to engraft more rapidly and effectively
Grant of $900,000 from Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) to fund the research
Constitutes a 3rd potential hematologic indication for PLX-R18

HAIFA, Israel, Dec. 27, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that it will collaborate with the New York Blood Center (NYBC) on preclinical studies of its Placental eXpanded (PLX)-R18 cells to enhance the efficacy of umbilical cord blood (UCB) transplantation. The project has been selected to receive a conditional award of $900,000 from Israel-U.S. Binational Industrial Research and Development Foundation (BIRD). Per the terms of the project, Pluristem will provide the PLX-R18 cells and the NYBC will be responsible for conducting and supporting the studies.

Umbilical cord blood cells, a rich supply of stem cells, are transplanted to restore a patient's bone marrow cells. Stem cell transplant can treat leukemia, lymphoma, immune deficiency, genetic diseases and other cancers. Prior preclinical research has suggested that PLX-R18 helps cord blood stem cells to engraft more rapidly and effectively than if they are administered alone. The ability to affect speed and extent of engraftment is clinically important, because a patient remains vulnerable to severe infection and other serious complications until transplanted stem cells begin to make mature blood cells.

Dr. Beth H. Shaz, Senior Vice President and Chief Medical and Scientific Officer of NYBC, commented, “This is an exciting opportunity to begin collaborating with Pluristem, using our considerable expertise and world-class facilities to explore the potential of Pluristem’s cells in a key hematologic research area. Based on previous data, we believe that PLX-R18 cells might contribute to a significant improvement in the success rate of umbilical cord blood transplants."

“PLX-R18 is emerging as a promising multifactorial treatment for hematologic conditions. It can potentially speed engraftment of umbilical cord blood cells and stimulate the production of all three types of blood cells: white and red blood cells, as well as platelets. We believe this offers a clear advantage over current therapies. We are thankful for the BIRD foundation for their support of this important project,” stated Pluristem Chairman and CEO Zami Aberman.

“Data from NYBC’s studies are expected to help round out the growing body of evidence for PLX-R18’s role in improving outcomes for patients living with hematologic diseases. We are very pleased that NYBC, a trusted source of cord blood and cellular therapies for practicing physicians and hospitals, is exploring the potential of PLX-R18’s use for future clinical applications,” Mr. Aberman added.

Support for the transplantation of CD34+ cells from umbilical cord blood constitutes the third potential hematologic indication for PLX-R18. The U.S. Food and Drug Administration has cleared a Phase I clinical trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic stem cell transplantation; the transplanted cells in this study can originate from bone marrow, peripheral blood, or umbilical cord blood. In addition, the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID) is currently conducting a dose-evaluation study of PLX-R18 in large animals, in advance of a possible pivotal trial for PLX-R18 in the treatment of Acute Radiation Syndrome (ARS) via the Animal Rule regulatory pathway. Human efficacy studies will not be required for FDA approval.