INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer
November 25, 2019 at 07:33 am
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INHIBITOR Therapeutics Inc. announced that the company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) to seek clearance to initiate an IND-opening clinical study as a two-part, multi-center, randomized, double-blind, placebo-controlled, Phase 2b clinical trial that will evaluate the efficacy and safety of SUBA-Itraconazole capsules dosed in combination with docetaxel and prednisone in patients with metastatic castrate resistant prostate cancer (mCRPC). The proposed trial will be named PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy).
Inhibitor Therapeutics, Inc. is a pharmaceutical development company. The Company is focused on developing and commercializing therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain cancers and certain non-cancerous proliferation disorders. Its primary focus is on the development of therapies initially for basal cell carcinoma (BCC), prostate and lung cancers in the United States utilizing itraconazole, a drug approved by the United States Food and Drug Administration (FDA) to treat fungal infections. The Company has developed intellectual property and know-how related to the treatment of cancer patients using itraconazole. The Company's intellectual property in the form of issued United States patents includes treatment and prognostic monitoring of proliferation disorders using hedgehog pathway inhibitors, and treatment of lung cancer using hedgehog pathway inhibitors.
INHIBITOR THERAPEUTICS, INC. 
