Also look for coverage of products in the pipeline for bladder pain syndrome/interstitial cystitis, prostate cancer, and male infertility.
FDA grants priority review to advanced bladder cancer agent
The FDA has accepted Genentech’s Biologics License Application (BLA) and granted priority review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The BLA submission for atezolizumab is based on results of the IMvigor 210 phase II study, and the FDA will make a decision on approval by Sept. 12, 2016, according to Genentech, which is a member of the Roche group.
First patients enrolled in U.S. IDE trial of BPH treatment
The first patients have been enrolled in the MedLift U.S. investigational device exemption (IDE) trial of the UroLift System. The MedLift IDE trial will be conducted across eight U.S. sites and is designed to demonstrate safety and effectiveness of the UroLift System for the treatment of patients with BPH who have an obstructive median lobe, which is currently contraindicated in the United States. Obstructive median lobes are present in approximately 5% to 10% of BPH patients who would otherwise be eligible for treatment with the UroLift System, according to manufacturer NeoTract, Inc.
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.
License agreement signed for use of stem cells in treating infertility
Creative Medical Technologies, Inc. has announced the signing of a license agreement with LA BioMed granting exclusive rights for United States patent application #14/508763, covering the use of stem cells for treatment of male infertility. In the patent application and a subsequent publication, Ronald S. Swerdloff, MD, an LA BioMed lead researcher, demonstrated that the administration of bone marrow cells into the testicles of mice with chemically induced damage to sperm-producing cells led to the generation of new sperm-producing cells.
First patient enrolled, treated in trial of urinary incontinence agent
The first patient has been enrolled and treated in the ADRESU trial, a late-phase, physician-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell Therapy in men with urinary incontinence after prostatic surgery for prostate cancer or BPH. ADRESU is a multicenter, 45-patient open-label controlled trial of the ECCI-50 cellular therapeutic and is based on promising pilot trial data published in the International Journal of Urology (2014; 21:294-300). The primary endpoint for the ADRESU trial will be the number of patients who experience reduction of urinary leakage volume (as measured by the weight of diaper pads used over 24 hours) 52 weeks after treatment, according to developer Cytori Therapeutics, Inc.
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