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Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. The studies were conducted in conjunction with ADI, the Association Duchenne Israel, whose members are parents of children with Duchenne. They are committed to helping to find a cure for Duchenne muscular dystrophy through research, clinical trials, and advocacy.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced it has completed the planned enrollment of 150 patients in a global Phase II trial of its PLacental eXpanded (PLX)-PAD cells for the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). The double blind, randomized, placebo controlled trial enrolled 50 patients since October 2015 in the U.S., Germany, Israel, and South Korea.

Pluristem Therapeutics Inc, a leading developer of placenta-derived cell therapy products, today announced that it has entered into a licensing agreement with TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to obtain a key patent in Japan to cover the treatment of ischemic diseases with placental cell therapy rounding out the Company's IP coverage. This license follows Pluristem's recent announcement that the Japan Patent Office granted the Company two key patents addressing three-dimensional methods for expanding placental and adipose cells, and specified cell therapies produced from placental tissue using these methods.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that the Japan Patent Office has granted the Company two key patents addressing: 1) Pluristem's core technology of three-dimensional expansion methods for producing therapeutic cell products derived from placental or fat cells; 2) the use of placenta-derived cells grown with this 3D technology to treat disorders of the hematopoietic system, such as disorders caused by exposure to radiation or chemotherapy, and failed engraftment of hematopoietic stem cell transplants. Pluristem continues to strengthen its IP position in order to support the current negotiations with pharmaceutical companies in Japan regarding potential partnerships for the development and commercialization of its PLacental eXpanded (PLX) cells. Pluristem recently received clearance for its protocol for a Phase 2 trial in critical limb ischemia targeting marketing approval in Japan, via Japan's accelerated regulatory pathway for regenerative medicines.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The clinical trial is expected to begin in the first half of 2016.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced the publication of a scientific study of PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Clinical Science. The paper, titled "Human Placenta-Derived Stromal Cells Decrease Inflammation, Placental Injury, and Blood Pressure in Hypertensive Pregnant Mice," describes the positive findings of a recent preclinical study of PLX-PAD cells for the treatment of preeclampsia. This marks the first published study indicating the superiority of placenta-derived mesenchymal cells in a therapeutic outcome as compared to cells derived from bone marrow or fat tissue, thus having implications beyond preeclampsia. Scientists also described the potential mechanism of action by which PLX-PAD cells treated symptoms of preeclampsia. Conducted by independent scientists at the Texas A&M Health Science Center/Baylor Scott & White Health, the paper was co-authored by scientists from the Health Science Center and Pluristem Therapeutics.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration has granted the Company's PLX-PAD cells Orphan Drug Designation in the treatment of severe preeclampsia. Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in approximately 1% of pregnancies in Western countries.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced it has expanded its five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité - University Medicine Berlin. The expanded agreement, which was executed on October 11th at the Berlin-Tel Aviv Business Forum in Tel Aviv, broadens the parties' cooperation to include identification of orthopedic indications that may be eligible for development under Europe's Adaptive Pathways and conditional marketing approval in the European Union. Pluristem's program to develop PLX cells in critical limb ischemia is already under discussion with the EMA and other European Stakeholders under the Adaptive Pathways.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced that Pluristem's Chairman and CEO, Zami Aberman, has been elected to serve on the Board of Directors of the Alliance for Regenerative Medicine (ARM). Based in Washington, D.C., ARM promotes research, development, investment and commercialization of regenerative medicine technologies. Pluristem has been a member of ARM for 3 years and has actively supported the organization's goals. Mr. Aberman joins other prominent leaders in the field of regenerative medicine who are currently serving on the board.

Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Company's PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan's accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time-limited marketing approval after a single successful Phase II trial.