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    Uro Pipeline: FDA grants priority review to advanced bladder Ca agent


    Company outlines proposed design for phase III trial of BPS/IC agent

    Aquinox Pharmaceuticals, Inc. has announced receipt of official minutes from its Dec. 8, 2015 meeting with the FDA’s Division of Bone, Reproductive and Urologic Products and provided an update on its plans for development of AQX-1125 for the treatment of patients with bladder pain syndrome/interstitial cystitis (BPS/IC). Discussed at the meeting were guidance and recommendations regarding proposed pivotal trial designs with AQX-1125 for BPS/IC, as well as additional supportive clinical, preclinical, and manufacturing activities that could potentially be required for registration. The proposed design for Aquinox’s intended first pivotal trial of AQX-1125 is a three-arm, randomized, double-blind, placebo controlled phase III clinical trial, with 12 weeks dosing followed by an open-label extension, to assess the efficacy and safety of AQX-1125 in both male and female BPS/IC patients. Patients will be randomized to receive one of two potential doses of AQX-1125 or placebo, according to Aquinox Pharmaceuticals.


    FDA to review supplemental NDA for prostate cancer treatment

    Astellas Pharma Inc. and Medivation, Inc. recently announced that the FDA has accepted for review a supplemental new drug application that they have submitted for enzalutamide (XTANDI) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the phase II TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act goal date for a decision by the FDA is Oct. 22, 2016. A Type-II variation to update the Summary of Product Characteristics has also been submitted to the European Medicines Agency.

    Next: License agreement signed for use of stem cells in treating infertility

    Benjamin P. Saylor
    Saylor is content managing editor for Urology Times.


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