Urology Product Preview February 2014

Enrollment begins for trial of PCa agent in non-metastatic disease

Medivation, Inc. and Astellas Pharma Inc. recently announced enrollment of the first patient in a global phase III clinical trial, known as PROSPER, which will evaluate the safety and efficacy of enzalutamide (Xtandi) in patients with non-metastatic castration-resistant prostate cancer (CRPC). The randomized, double-blind, placebo-controlled, multinational trial plans to enroll approximately 1,500 patients with non-metastatic CRPC at sites in the U.S., Canada, Europe, South America, and the Asia Pacific region. PROSPER will enroll a high-risk subgroup of patients with prostate cancer who are progressing despite androgen deprivation therapy, but who are asymptomatic with no prior or present evidence of metastatic disease. The primary endpoint of the trial is metastasis-free survival.

Generic version of popular ED agent to launch in 2017 after settlement

Teva Pharmaceuticals, USA Inc. has been granted permission to launch a generic version of sildenafil citrate (Viagra) in the U.S. on Dec. 11, 2017, or earlier under certain circumstances. The permission came as part of a settlement of litigation between Teva and Viagra manufacturer Pfizer Inc. Teva will pay Pfizer a royalty for a license to produce its generic version. Teva has received tentative approval from the FDA for its generic version, the company said in a statement.

Patient enrollment commences for study of single-incision sling

Boston Scientific recently enrolled its first patient in a postmarket surveillance study of the company’s Solyx Single System, a single-incision sling system for the treatment of stress urinary incontinence. Boston Scientific initiated the study to compare a single-incision midurethral sling to a standard outside-in transobturator sling. Enrollment at up to 30 centers is expected to be completed by the first or second quarter of 2014, the company said. Continue to next page for more.

Phase I/II trial of solid tumor cancer agent adds second study site

MD Anderson Cancer Center, Orlando, FL has become the second site participating in the phase I/II clinical trial of DCVax-Direct, Northwest Biotherapeutics’ next-generation dendritic cell product for the potential treatment of all inoperable solid tumor cancers. MD Anderson-Orlando joins MD Anderson-Houston, where the first DCVax-Direct patients were enrolled, while other patients are going through assessment for eligibility, according to Northwest Biotherapeutics. The primary endpoint of the trial for measuring the efficacy of DCVax-Direct is tumor regression.

Promising phase I data of PCa immunotherapeutic agent published

Data from a phase I trial of an immunotherapeutic agent for patients with prostate cancer, published in Cancer Immunology, Immunotherapy (2013; 62:1599-608), demonstrated that the compound is safe, well tolerated, and generated a specific and robust immune response. Three years after the last dose of the compound, known as AE37, was administered, elevated levels of specific immunity could be detected, demonstrating that the vaccine had induced long-term immunologic memory, according to Generex Biotechnology Corp., whose subsidiary Antigen Express Inc. is developing the agent.

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