Pluristem has an exclusive out-license and strategic partnership agreement with Cha Biotech (Kosdaq:CHA) for the development and use of PLX-PAD in Critical Limb Ischemia (CLI), and Intermediate Claudication (IC), with rights exclusively in South Korea. Cha Biotech will perform and fund clinical trials in South Korea under the supervision of the Korea Food & Drug Administration (KFDA). Upon a regulatory approval for a PLX product in South Korea, Pluristem and Cha have agreed to establish a joint venture (JV) co-owned by the parties to commercialize PLX cell products in South Korea.
U.S. National Institutes of Health
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), will initiate studies in large animals to evaluate dosing for PLX-R18 as a medical counter measure in the treatment of the hematologic component of Acute Radiation Syndrome (ARS). Once the optimal dose is determined in large animals, a pivotal trial could be conducted and the results used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. The NIAID is supporting and collaborating on the dosing studies, and previously supported and completed two preclinical studies of PLX-R18 as a potential treatment for the hematologic syndrome of ARS, with those studies showing a substantial and statistically significant increase in the survival of irradiated rodents treated with PLX-R18 versus placebo, and revealing the underlying mechanism of action of our cells in this indication.