Urology Product Preview

January 1, 2011

Urology drugs and devices that are in the pipeline from Pfizer Inc., Exelixis Inc., Medivation, Inc., Astellas Pharma Inc., Tengion, Inc., Agensys, Inc., and Nymox Pharmaceutical Corp.

Positive results seen in phase III trial of investigational RCC agent

Pfizer Inc. said the phase III AXIS 1032 trial, studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma, has met its primary endpoint.

In the study, axitinib, an oral and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, met the primary endpoint of significantly extending progression-free survival for patients with metastatic RCC when compared with sorafenib (Nexavar). The trial included patients whose disease had progressed after first-line therapy.

Exelixis Inc. has announced promising interim data from patients with metastatic castration-resistant prostate cancer treated with CL 184 in an ongoing phase II adaptive randomized discontinuation trial.

The trial includes patients with and without prior treatment with docetaxel (Taxotere). Based on an independent review, 95% of the patients achieved complete or partial resolution of lesions on bone scan, with most resolving at the first post-baseline assessment at 6 weeks.

To date, a single docetaxel (Taxotere)-pretreated patient achieved stabilization of bone scan as his best evaluation, and no patient exhibited worsening on bone scan as his best time point assessment.

Most patients exhibited decreases in the blood-based bone metablism biomarkers alkaline phosphatase and C-terminal telopeptides of type 1 collagen, which are often increased in patients with metastatic bone lesions who are at risk for skeletal morbidity.

Phase III enrollment completed for advanced prostate cancer drug

Enrollment has been completed for the phase III AFFIRM study of MDV3100, a novel triple-acting oral androgen receptor antagonist being studied for the treatment of advanced prostate cancer, according to Medivation, Inc. and Astellas Pharma Inc.

The randomized, double-blind, placebo-controlled study has 1,199 subjects enrolled and will evaluate the use of MDV3100, 160 mg/day, for patients with advanced prostate cancer who have previously been treated with chemotherapy.

The primary endpoint of the study is survival. The secondary endpoints include progression-free survival, safety, and tolerability.