Pluristem Therapeutics (NASDAQ: PSTI) announced that following preliminary discussions with several governmental authorities, it will expand its research and development efforts on an acute radiation exposure treatment. The announcement comes as governments around the world have broadened their search for easily administered and effective radiation countermeasures.
Liat Flaishon, MD, PhD, recently appointed Pluristem's Director of Business Development, will lead the company's development efforts.
Dr. Flaishon joins Pluristem after serving as the director of Drug Safety Risk Management in the global drug safety and pharmacovigilance department at Teva Pharmaceuticals. Dr. Flaishon received her medical degree from the Sackler School of Medicine, Tel-Aviv University, and her PhD in Immunology from The Weizmann Institute of Science.
As previously announced, Pluristem's PLX cells have achieved favorable pre-clinical data in the treatment of radiation exposure. In studies conducted by Professor Raphael Gorodetsky and his team at the Biotechnology and Radiobiology Laboratory at the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, Pluristem’s placental 3D expanded cells have demonstrated efficacy as mitigators of the acute radiation syndrome (ARS) following radiation exposure in animals that were given lethal doses of radiation and 24 hours later were treated with these cells. According to these studies’ findings, a statistically significant increased survival rate (3-4 fold) was observed in those animals treated with Pluristem’s cells over the untreated control animals. Additionally, bone marrow cellularity was significantly elevated following the administration of the placental cells throughout the follow-up period. These beneficial effects may be attributed to the cytoprotective effect and/or the immunomodulatory properties of PLX cells.
“Following announcement regarding our initial studies on radiation treatment, we have seen significant interest in our radiation product candidate”, said Zami Aberman, Chairman and CEO of Pluristem. "Currently, there is an extensive search for an easily administered and effective product for radiation countermeasures. We believe that our PLX cells have the potential to both extend the window of treatment for radiation victims and to become an off-the-shelf nuclear catastrophe countermeasure product."
Daily Dose Conclusion: ARS (Acute Radiation Syndrome) is really three sub-syndromes but the standard of care for radiation exposure remains a bone marrow transplant. A rapid off the shelf allogeneic product is a perfect fit for this type of medical counter measure (MCM).
Importantly the key drive for PSTI is progress in CLI (Critical Limb Ischemia). REPORTS circulated yesterday that PSTI was looking to divest or exit the CLI indication. Those reports appear totally unfounded. While Aastrom (ASTM) has the most advanced therapy for CLI (now in P3) the COGS equation for an allogeneic product will give PSTI a great advantage versus ASTM. So the key question will be autologous versus allogeneic, and all of the implications that accompany the two very different approaches such as cellular integration, the need and cost to re-treat and the efficacy of autologous versus allogeneic (placental derived) cells.
The answers clinically are not known yet but given the size of the opportunity there is room for more than one therapy. We are hopeful that Aastrom has enough power (enough patients) to meet the primary endpoint (AFS – amputation free survival) and that will be positive for all the cell therapy companies.