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    Uro Pipeline: FDA accepts biologics license application for bladder Ca agent

     

    NDA submitted for subcutaneous hypogonadism treatment

    Antares Pharma, Inc. has submitted a new drug application for QuickShot Testosterone (QST), an investigational drug-device combination product that uses a subcutaneous auto injector to deliver testosterone enanthate. The product is intended for the treatment of hypogonadism. The QST phase III study consisted of a 1-year pivotal safety and efficacy study plus a second 6-month safety study involving 283 men. Patients involved received 75 mg of testosterone enanthate once weekly for 6 weeks. Blind dose adjustments were made after week 7, and the patients received subcutaneous doses of 50 mg, 75 mg, or 100 mg of testosterone weekly for up to 52 weeks.

    Phase II data suggest drug’s efficacy in HPV-related genital warts

    Novan has released the results of its phase II clinical trial on SB206 for the treatment of genital warts caused by human papillomavirus (HPV). In the randomized, double-blind, vehicle-controlled trial, the safety and efficacy of the drug were evaluated in 107 patients with external genital warts and perianal warts. The primary endpoint was the proportion of patients who were completely clear of warts that were present at baseline at or before week 12. When treated with SB206 12% once daily, 33% of patients achieved clearance compared to 4% of patients treated with vehicle once daily. Cutaneous tolerability was monitored throughout the study, and the most frequently reported treatment-emergent adverse reactions were application site reactions. Novan expects to continue conversations on SB206 with the FDA in the first half of 2017 and depending on phase II results will initiate phase III trials in the second half of the year.

    Erectile dysfunction treatment receives broad patent coverage

    Can-Fite BioPharma, Ltd. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application regarding A3 adenosine receptor (A3AR) ligands for use in the treatment of erectile dysfunction. The patent focuses on methods of treatment for erectile dysfunction with different A3 adenosine receptor ligands, including Can-Fite’s erectile dysfunction drug, CF602. CF602 is an allosteric compound that showed effects on erection superior to sildenafil citrate (Viagra) in diabetic animal studies, Can-Fite said. In February 2016, the company received a Notice of Allowance addressing composition of matter for allosteric compounds. CF602 is being prepared for an IND submission to the FDA and a phase I trial.

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    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.

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