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    Uro Pipeline: Data from mUC combination therapy suggests efficacy, safety

     

    Combination bladder Ca treatment yields positive phase II results

    A phase II trial of apatorsen in combination with docetaxel yielded positive results in a final analysis, according to OncoGenex Pharmaceuticals, Inc. Apatorsen is designed to reduce the production of heat shock protein 27 to disable the defense mechanisms of cancer cells from developing resistance to treatment. The study, performed at 28 sites across the United States, enrolled 200 patients with metastatic bladder cancer who had progressed following first-line platinum-based chemotherapy. Researchers found that patients who received the apatorsen combination treatment experienced a 20% decrease in risk of death compared to the patients who were receiving just docetaxel. The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.

    First patient dosed with oral treatment for hypogonadism

    Diurnal Group, plc has successfully dosed the first patient in a phase I clinical trial of native oral testosterone formulation (DITEST) to treat hypogonadism. The study will focus on pharmacokinetics, safety, and tolerability of the formulation. The effects will be studied in a randomized trial in 24 adult males with primary or secondary hypogonadism with a primary endpoint comparing the rate and extent of absorption of testosterone from a single dose of DITEST with a single dose of testosterone undecanoate, 80 mg. The secondary endpoints will measure the impact of food on the rate and extent of absorption of testosterone from DITEST and compare the safety and tolerability of two different dosage levels. Data are expected to be available in mid-2017.

    More from Urology Times:

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

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