Urology Product Preview

April 1, 2011

Urology drugs and devices that are in the pipeline from Auxilium Pharmaceuticals, Inc., Bavarian Nordic, Antares Pharma, Inc., Endo Pharmaceuticals, Bioniche Life Sciences, Inc., and Pfizer Inc.

Enrollment for phase III study of Peyronie's agent complete

Auxilium Pharmaceuticals, Inc. recently announced the completion of enrollment for a double-blind placebo-controlled phase III study of a non-surgical treatment for Peyronie's disease (collagenase clostridium histolyticum [Xiaflex]).

All patients were scheduled to receive their first injection of the treatment by March 2011. The late-stage global development plan, known by the acronym IMPRESS, consists of four clinical studies: two randomized, double-blind, placebo-controlled studies, one open-label study, and one pharmacokinetic study.

Phase II study compares combined therapy versus singular therapy

Bavarian Nordic has initiated a randomized phase II study of Prostvac, a therapeutic vaccine being investigated for the treatment of castration-resistant prostate cancer. The study will compare Prostvac followed by docetaxel (Taxotere) versus docetaxel alone.

The Prostvac group will receive accelerated Prostvac treatment followed by docetaxel and prednisone, while the control group will receive upfront docetaxel and prednisone. Bavarian Nordic expects the study to be fully enrolled with 144 patients by 2012.

The primary endpoint of the study is overall survival, while secondary endpoints include PSA response rates and the association among development of PSA-specific immune response, time to progression, and overall survival in treated patients.

New drug application filed for overactive bladder agent

Antares Pharma, Inc. has filed a new drug application with the FDA for a gel formulation of oxybutynin (Anturol Gel). The drug is intended for patients with overactive bladder.

This submission was supported by a phase III trial, which showed a statistically significant reduction in incontinence episodes for both doses studied (56 mg or 84 mg daily).

First patient enrolled in second phase III trial of cancer treatment

Endo Pharmaceuticals and Bioniche Life Sciences, Inc. recently announced enrollment of the first patient in a second phase III clinical trial of an intravesical formulation of Mycobacterial cell wall-DNA complex (Urocidin) in the treatment of BCG-recurrent or refractory nonmuscle-invasive bladder cancer.

The trial is a randomized, active-controlled, open-label, multicenter study with a blinded endpoint assessment comparing the treatment with mitomycin C (Mutamycin).

The companies estimate the trial will include 450 patients worldwide.

Phase III trial of mRCC treatment yields positive results

Pfizer Inc. announced the positive results of a phase III trial of axitinib in previously treated patients with metastatic renal cell carcinoma.

In the study, axitinib significantly extended progression-free survival when compared with sorafenib (Nexavar). Axitinib, an inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, also demonstrated a generally manageable safety profile.