Indication intelligence, analysis and sector perception

Pluristem (PSTI) National Institutes of Health’s NIAID initiating dose evaluation studies

February 16, 2016 8:56am

So what, animal models of PSTI’s PLX-R18 in the treatment of Acute Radiation Syndrome are still very, very early and the large animals not yet in the cage …

The 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 Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic components 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. In September 2015, the FDA had confirmed that data from earlier trials conducted by NIAID were sufficient for the future design of studies in Pluristem’s development path for PLX-R18. NIAID is supporting and collaborating on the dosing studies, and Pluristem is supplying PLX-R18.

The Bottom Line: The LARGE animals haven’t even been dosed and PSTI “mentions” a BLA - ? The NIH has only to date - supported and completed two mouse studies of PLX-R18 as a - potential treatment of the component of ARS that affects bone marrow function

John Steinbeck’s “Of mice and men” is still a work of fiction; hyperbole is still PSTI’s middle name and idealized relationships are usually doomed!

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