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Protalex receives approval for clinical trial for Phase Ib study of PRTX-100.

M2 EQUITYBITES-October 7, 2015-Protalex receives approval for clinical trial for Phase Ib study of PRTX-100


Protalex (OTCQB:PRTX), a clinical-stage biopharmaceutical company, has received approval from the French National Agency for Medicines and Health Products for its clinical trial application to start a Phase Ib study of PRTX-100, it was reported yesterday.

The product is intended to treat persistent/chronic immune thrombocytopenia in adult patients.

The company now aims to start the PRTX-100-203 trial at several sites in France with patient enrolment likely to commence by the end of 2015. The approval to commence the trial and the positive COMP opinion follow the company's earlier announced initiation of a US Phase I/II clinical trial of PRTX-100 in adult ITP patients and receipt of orphan drug designation for the drug to treat ITP from the Office of Orphan Products Development of the US Food and Drug Administration.

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Publication:M2 EquityBites (EQB)
Date:Oct 7, 2015
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