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Pluristem (PSTI) yet, another meeting and animal study to determine a protocol - HOLD

September 21, 2015 7:26am

PSTI and NIAID met with U.S. FDA and agreed on a development plan for initiation of pivotal study of PLX-R18 in the treatment of Acute Radiation Syndrome. Just the usual “puff”!

PSTI and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), completed a successful meeting with the U.S. FDA regarding the development program for PLX-R18 cells in the treatment of Acute Radiation Syndrome (ARS).

The FDA communicated that the data presented at the meeting allow for the design of large animal studies, which are the only studies required proving efficacy for FDA approval under the Animal Rule; this is the regulatory pathway followed when human efficacy trials are not ethical or feasible.

The Bottom Line: The FDA advised PSTI to conduct a pilot study in large animals to determine the optimal dose of PLX-R18 as a treatment for the hematologic component of ARS. Once the optimal dose schedule is determined, a pivotal trial in large animals could commence. If successful, this trial would provide sufficient efficacy data for an application to the FDA for approval of PLX-R18 as a treatment for ARS.

PSTI closed at $2.10 on 9/18; when the study begins, let us know for the share price to be effected. It is NOT a will happen but, if other matters are resolved, the trial might begin! Tired of could, would or should – it happens or it doesn’t?

PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce blood cells due to a variety of causes including ARS, certain cancers, or immune-mediated bone marrow failure. Pluristem is preparing to initiate a PI trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. With its capabilities, PLX-R18 could potentially treat a broad range of indications related to bone marrow function, which together constitute a substantial global market.

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