Urology Product Preview

March 1, 2013

Drugs and devices in the pipeline from Bayer Healthcare, AVEO Oncology, Astellas Pharma Inc., Trimel Pharmaceuticals Corp., OncoGenex Pharmaceuticals, Inc., Nymox Pharmaceutical Corp., Spectrum Pharmaceuticals, and Tengion, Inc.

Advanced prostate cancer agent granted priority review by FDA

The FDA has granted priority review to the new drug application for radium-223 dichloride (radium-223), an investigational oncology compound. The application is under review for the treatment of castration-resistant prostate cancer patients with bone metastases.

The NDA submission, filed in December 2012, was based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. In the study, radium-223 significantly increased overall survival by 44% (HR=0.695, p=.00007), resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival benefit in patients with radium-223 was 3.6 months, based on 14.9 months overall survival with radium-223 plus best standard of care (BSoC) versus 11.3 months with placebo plus BSoC, according to developer Bayer Healthcare.

Survival results reported in phase III study of advanced RCC agent

AVEO Oncology and Astellas Pharma Inc. recently announced overall survival (OS) results for tivozanib, an investigational agent, from the phase III TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study in patients with advanced renal cell carcinoma. The final OS analysis, as specified by the protocol, shows a median OS of 28.8 months (95% confidence interval [CI]: 22.5–NA) for tivozanib versus 29.3 months (95% CI: 29.3–NA) for the comparator arm, sorafenib (Nexavar). No statistical difference between the two arms (HR=1.245, p=.105) was observed.

The OS data are included in the tivozanib  new drug application filing and were presented at the annual Genitourinary Cancers Symposium in Orlando, FL.

Men give positive feedback in intranasal TRT phase III trial

Patients participating in a phase III study of the investigational intranasal testosterone replacement therapy CompleoTRT reported that they felt better when using the treatment compared with other therapies.

The quantitative study surveyed 99 patients who had a minimum of 90 days of CompleoTRT treatment, 50 of whom were previously treated with another testosterone replacement therapy. For those patients who had previous experience with other testosterone replacement therapies, 42% indicated that they felt better on CompleoTRT as compared to their previous experience, while 34% felt the same.

When asked if they would use CompleoTRT if it were approved and available by prescription, 70% of those who were previously treated with a testosterone replacement therapy would adopt CompleoTRT rather than return to their previous therapy, according to manufacturer Trimel Pharmaceuticals Corp.

Peyronie’s agent shows improved curvature, symptom scores

Data from the phase III trials of the agent collagenase clostridium histolyticum (CCH [XIAFLEX]), a novel, in-office, biologic for the potential treatment of Peyronie’s disease, have been published online in the Journal of Urology (Feb. 1, 2013).

According to the results of a post-hoc meta-analysis of the phase III IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials, CCH-treated subjects showed a mean 34% improvement in penile curvature deformity (mean change, –17.0±14.8° per subject) compared with a mean 18.2% improvement in placebo-treated subjects (mean change, –9.3±13.6° per subject) (p<.0001). Mean change in Peyronie’s disease symptom bother score was significantly improved in CCH-treated (–2.8±3.8) versus placebo (–1.8±3.5, p=.0037) subjects.

Advanced bladder cancer treatment moves into phase II study

OncoGenex Pharmaceuticals, Inc. recently announced plans for the initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized, controlled phase II study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy treatment. The trial, which is the fourth phase II study of OGX-427 in a genitourinary cancer, will investigate whether combining OGX-427 with docetaxel (Taxotere) improves survival compared to docetaxel alone.

Positive safety, efficacy data reported for BPH treatment

Nymox Pharmaceutical Corp. released new positive phase III safety and efficacy data for the company’s U.S. study NX02-0020. The NX02-0020 study is a prospective clinical safety evaluation of re-injection of the company’s NX-1207 agent for BPH. Study participants consisted of 192 consecutively treated men who had previously participated in the completed NX02-0014 and NX02-0016 phase II trials or in the ongoing NX02-0017 and NX02-0018 trials and who wished an open-label injection of NX-1207.

The mean duration from the initial injection to the final assessment was 26 months. Improvement in AUA BPH Symptom Index score was assessed over this period, and the mean overall improvement in the 192 treated men was 7.6 points (p<.001), according to Nymox.

Company reacquires development rights for bladder cancer agent

Spectrum Pharmaceuticals has reacquired development and commercialization rights for apaziquone in the United States, Europe, and other territories pursuant to an agreed-upon restructuring of Spectrum’s collaboration with Allergan, Inc. In exchange, Allergan will receive a royalty on future revenue.

Apaziquone is an anticancer agent being developed for the treatment of nonmuscle-invasive bladder cancer as a single instillation following transurethral resection of bladder tumor.

Phase I trial advances for urinary diversion device

Tengion, Inc. announced that it has successfully implanted the seventh patient in its ongoing phase I clinical trial of the Neo-Urinary Conduit, which is for use in bladder cancer patients requiring a urinary diversion following cystectomy.

The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients.

The Neo-Urinary Conduit offers patients potential improvements over the standard of care, including a shorter and less complex surgical procedure, improved recovery times and faster hospital discharges, as well as no evidence of the typical postoperative comorbidities associated with the current standard of care, according to Tengion.