Urology Product Preview

July 1, 2011

Urology drugs and devices that are in the pipeline from Bayer Healthcare, Tengion, Inc., Advantagene, Inc., Hybrigenics, and Vivus.

Trial of metastatic PCa agent stopped based on positive data

Bayer Healthcare announced that a phase III trial of radium-223 chloride (Alpharadin) has met its primary endpoint and the trial will stop. Bayer said the agent, an investigational alpha-pharmaceutical, significantly improves overall survival in patients with castration-resistant prostate cancer that has spread to the bone. Patients who were previously on the placebo arm of the trial will now be offered treatment with radium-223 chloride.

The median overall survival was 14.0 months for radium-223 chloride versus 11.2 months for placebo (p=.002). Complete study results will be presented at an upcoming scientific meeting.

A phase III clinical trial of avanafil, an investigational drug for the treatment of erectile dysfunction, yielded positive results that were presented at the Cancer Survivorship and Sexual Health Symposium in Washington.

The drug met all primary endpoints, including improvements from baseline erectile function measured by the Sexual Encounter Profile and in the erectile function domain of the International Index of Erectile Function. There were no serious adverse events or deaths reported in the study, and the most commonly reported side effects included headache, flushing, and nasopharyngitis.

FDA grants orphan drug designation to neo-urinary conduit

The FDA has granted orphan-drug designation to Tengion, Inc.'s Neo-Urinary Conduit for treatment of bladder dysfunction requiring incontinent urinary diversion.

The designation allows Tengion 7 years of marketing exclusivity within the U.S. An initial clinical trial is ongoing for the product, which is an autologous implant intended to catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following cystectomy.

Drug maker, FDA agree on phase III trial of prostate cancer vaccine

Advantagene, Inc. and the FDA have recently agreed upon a Special Protocol Assessment for a phase III clinical trial of ProstAtak. The randomized study will evaluate the treatment's ability to prevent prostate cancer recurrence.

If successful, this could be the first drug product for newly diagnosed, localized prostate cancer, according to Advantagene.

The drug is designed to kill tumor cells and stimulate a vaccine effect against the patient's specific tumor. Developers hope it activates the patient's own immune system to prevent tumor recurrence.

Agent shows positive results in men with hormone-refractory PCa

Hybrigenics recently announced positive results from a phase IIa study of daily oral inecalcitol in combination with docetaxel (Taxotere) in hormone-refractory prostate cancer patients.

The maximum tolerated dose of inecalcitol is 4 mg per day and the response rate to combination treatment reached 85% based on PSA decline within 3 months. Out of 52 patients treated with up to 4 mg per day, 47 were evaluable by PSA monitoring and 40 patients showed more than a 30% decrease in PSA levels within 3 months.