Urology Product Preview

September 1, 2010

Urology drugs and devices that are in the pipeline.

Study comparing RCC agents reaches enrollment target

AVEO Pharmaceuticals, Inc. announced its achievement of the enrollment target of 500 patients for TIVO-1, a global phase III clinical trial for tivozanib (AV-951), an oral, triple VEGF receptor inhibitor. The trial involves patients with advanced renal cell carcinoma.

AVEO said TIVO-1 is a randomized, controlled trial evaluating tivozanib compared to sorafenib (Nexavar). The primary endpoint is the progression-free survival of the two drugs. The company says data from TIVO-1 should be available in mid-2011.

Amgen recently announced that the FDA has granted priority reivew designation to denosumab, a subcutaneous RANK Ligand inhibitor for the treatment of bone metastases to reduce skeletal-related events in patients with cancer.

Priority review designation is granted to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. Denosumab is the first therapy to target the RANK/RANKL pathway believed to play a central role in cancer-induced bone destruction, according to Amgen.

The biologics license application submission, filed in mid-May with the FDA, summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three pivotal phase III head-to-head trials versus zoledronic acid (Zometa).

Cephalosporin for complicated UTI meets phase II study objectives

A recently completed phase II study of CXA-101, a cephalosporin for the treatment of complicated urinary tract infections in adults, met its study objectives, according to Cubist Pharmaceuticals, Inc.

The study met its objectives of assessing the safety and efficacy of CXA-101 in comparison to ceftazidime (Fortaz, Tazicef). CXA-101 also showed favorable microbiologic and clinical outcomes at the test of cure visit, 6 to 9 days after end of therapy.

Cubist is currently developing an agent known as CXA-201 as a first-line intravenous therapy for the treatment of serious gram-negative bacterial infections. The drug would be a combination of CXA-101 and the beta-lactamase inhibitor tazobactam.

FDA OKs indication statement for fertility-preserving low T agent

Repros Therapeutics Inc. said that the FDA has concurred with Repros' indication statement for the use of enclomiphene (Androxal) in the treatment of secondary hypogonadism in men wishing to preserve fertility.

The FDA agreed with the proposal to conduct controlled studies in order to demonstrate the benefit of enclomiphene in fertile hypogonadal men with normal gonadotropin levels, but also requested specific information on how Repros will define male fertility and how it will be measured. A protocol is being drafted to address the FDA's comments.

Separately, Larry I. Lipshultz, MD, of Baylor College of Medicine, Houston, has agreed to serve as lead investigator for the enclomiphene phase III program and will help Repros prepare protocols. Studies are being designed to show that enclomiphene normalizes both testosterone and sperm concentrations as compared to topical testosterone or placebo.