Urology Product Preview

July 29, 2013

Drugs and devices in the pipeline from Targacept, Inc., Cubist, OncoGenex Pharmaceuticals, Inc., Apricus Biosciences, and Nymox Pharmaceutical Corp.

Phase IIb study initiated for overactive bladder agent

Targacept, Inc. recently announced the initiation of a phase IIb clinical study of TC-5214 as a treatment for overactive bladder. TC-5214 acts potently on alpha3beta4 and other neuronal nicotinic receptors located in or around the bladder that are believed to play a key role in bladder contraction and signaling of the urge to urinate. The double-blind, placebo-controlled, randomized, parallel-group trial’s co-primary endpoints are change in micturition frequency per 24 hours and change in urinary incontinence episodes per 24 hours, in each case from baseline to 12 weeks.

Antibiotic for complicated UTI granted FDA fast track status

The FDA has granted the late-stage antibiotic candidate ceftolozane/tazobactam (CXA-201) fast track status for complicated urinary tract infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, both of which were previously granted Qualified Infectious Disease Product (QIDP) indications. The QIDP designation allows Cubist, the drug’s developer, to benefit from certain incentives for the development of new antibiotics, including Priority Review, fast track status, and, if ceftolozane/tazobactam is approved by the FDA, a 5-year extension of Hatch-Waxman exclusivity. IV ceftolozane/tazobactam is being studied in phase III trials for the treatment of complicated UTIs and complicated intra-abdominal infections caused by gram-negative pathogens.

Enrollment complete for phase II trial of advanced bladder Ca agent

Enrollment has been completed in Borealis-1, a company-sponsored, randomized, placebo-controlled phase II trial of OGX-427 in combination with first-line gemcitabine (Gemzar) and cisplatin in patients with metastatic bladder cancer. Approximately 180 patients have been randomized into Borealis-1 at 55 clinical sites throughout North America and Europe, according to OncoGenex Pharmaceuticals, Inc., the agent’s manufacturer. The three-arm trial randomized patients to receive gemcitabine, cisplatin, and OGX-427 at two dose levels (600 mg or 1,000 mg) versus gemcitabine, cisplatin, and placebo. The primary endpoint of the trial is overall survival.

ED agent shows efficacy in men unresponsive to PDE-5 inhibitors

Phase III data for Vitaros, a product candidate for the treatment of erectile dysfunction, were presented at the AUA annual meeting in San Diego. The analysis evaluated the safety and efficacy of Vitaros after 12 weeks, and longer term use, in men previously unresponsive to phosphodiesterase type-5 inhibitors. Results showed that 200-mcg and 300-mcg doses of Vitaros improved erections in this population, and adverse events were mild to moderate, similar to those seen in the control group, and decreased with repeated exposure, according to Apricus Biosciences, which is developing the drug.

Committee reports no significant safety concerns over BPH agent

Nymox Pharmaceutical Corp. reported favorable results from the most recent Safety Monitoring Committee review of ongoing safety data for the company’s NX02-0017 clinical trial, one of the two phase III pivotal trials for NX-1207, Nymox’s investigational drug for BPH. The July 9, 2013 Safety Monitoring Committee meeting found no significant safety concerns to date.UT

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