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OBI Pharma Inc passes US FDA's clearance for Phase I/II study of OBI-3424 in cancer patients who over-express AKR1C3.

M2 EQUITYBITES-April 20, 2018-OBI Pharma Inc passes US FDA's clearance for Phase I/II study of OBI-3424 in cancer patients who over-express AKR1C3

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Taiwan biopharma company OBI Pharma Inc (TPEx:4174) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) clearance for an investigational new drug (IND) application for a Phase I/II study of OBI-3424 in solid and liquid tumors in cancer patients who over-express AKR1C3.

Following the US FDA's clearance, the company intends to enroll patients with local solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC).

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3) and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. AKR1C3 is highly expressed in up to 15 solid and liquid tumors, added the company.

According to the company's chief medical advisor, Tillman Pearce, M.D., this clinical trial intends to verify the safety and preliminary activity profile of OBI-3424 in a variety of solid and liquid tumors.

The company will conduct this first-in-man clinical trial at the University of Texas M.D. Anderson Cancer Center and The James Cancer Hospital and Solove Research Institute of Ohio State University, two of America's leading academic oncology research institutions, added Dr Pearce.

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Publication:M2 EquityBites (EQB)
Date:Apr 20, 2018
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