Urology Product Preview

April 30, 2013

Drugs and devices in the pipeline from Medivation, Inc.; Astellas Pharma Inc.; TARIS Biomedical; Exelixis, Inc.; and Bioniche Life Sciences Inc.

Data on PCa agent’s pre-chemo use expected in 2013
Medivation, Inc. and Astellas Pharma Inc. have established an updated interim analysis plan for the PREVAIL trial, a global phase III clinical trial evaluating enzalutamide (Xtandi) capsules in men with metastatic castration-resistant prostate cancer who have not yet received chemotherapy. The planned interim analysis for the trial is expected to occur in 2013. In addition, the protocol-specified number of radiographic progression-free survival (PFS) events has been exceeded, and the primary PFS analysis will occur at the time of the interim analysis for overall survival, the companies reported.

First patient dosed in phase II trial for IC device
TARIS Biomedical has dosed the first patient in its second phase II clinical study with LiRIS, its novel product candidate, in patients with interstitial cystitis. LiRIS is designed to continuously deliver lidocaine over an extended period directly to the bladder of patients with IC.


This multicenter, randomized, double-blind, placebo-controlled phase II clinical study will evaluate the safety and efficacy of LiRIS in up to 124 patients with IC. Patients who successfully complete the randomized trial will be eligible to participate in a subsequent open-label extension arm where all patients are eligible to receive LiRIS. TARIS said it plans to conduct this study in up to 15 investigational sites in the U.S. and Canada.

Prostate Ca agent inhibits tumor growth in early trial
Treatment of tumor-bearing animals with the investigational agent cabozantinib, which is being developed for the treatment of prostate tumors that have metastasized to the bone, resulted in rapid and substantial inhibition of tumor growth evident by both bioluminescent and magnetic resonance imaging techniques. Monitoring tumors in cabozantinib-treated animals using diffusion-weighted MRI showed a significant increase in the apparent diffusion coefficient (ADC) compared to tumors in vehicle-treated animals. Histologic examination of tumors from cabozantinib-treated animals showed substantial tumor cell death, further validating the link between increases in tumor ADC and anti-tumor activity, according to manufacturer Exelixis, Inc. Findings were presented at the American Association for Cancer Research annual meeting in Washington.

Sponsorship of bladder Ca product returned to Bioniche
Bioniche Life Sciences Inc. said that sponsorship of its phase III bladder cancer product Urocidin has been returned to the company from former development/marketing partner Endo Pharmaceuticals. The companies previously announced that they had come to an agreement whereby Endo would return global rights to Urocidin. Since that time, Endo has completed all termination activities related to the original license agreement between the two companies and sponsorship has now been officially returned to Bioniche. Urocidin is a formulation of mycobacterial cell wall-DNA complex that has a dual mode of action: immune stimulation and direct anticancer activity.

Add-on for urine collection bag eliminates pressure
A prostate cancer survivor has developed and patented a pain-free urinary catheter bag. The manufacturing add-on for urine collection bags allows inside and outside air pressure to equilibrate, thus eliminating the partial negative pressure in the bag. As a result, pain and other complications attributable to the “siphon effect” are reduced or eliminated. The inventor, who can be reached at lewis.zeller@yahoo.com, is seeking companies interested in licensing the add-on device.