Urology Product Preview

March 1, 2011

Urology drugs and devices that are in the pipeline from Exelixis, Inc., ADVENTRX Pharmaceuticals, Viking Systems, Inc., Epigenomics AG, and Predictive Biosciences.

Castration-resistant prostate Ca drug shows positive phase II results

Exelixis, Inc. has reported positive data from phase II trials of XL184 (cabozantinib), a drug being tested for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). The data support the findings that XL184 reduces or stabilizes metastatic bone lesions, reduces bone pain and narcotic analgesic medication, and results in an increase in hemoglobin in patients with anemia.

The data also suggest that XL184 shows an encouraging early signal of durable clinical benefit in both docetaxel (Taxotere)-naive and pretreated patients, according to a statement from Exelixis.

FDA: Additional development needed for chemo formulation

The FDA has determined that ANX-514, a polysorbate 80-free formulation of docetaxel, could not be approved based on the findings of a bioequivalence study of the drug and that additional development activities would be required for approval.

ADVENTRX Pharmaceuticals, the drug's maker, met with the FDA to discuss required activities, including the conceptual design of a single, additional clinical study that could support approval of ANX-514. ADVENTRX said it believes the study requested by the FDA is reasonable, and is developing a study protocol for submission to the agency.

Visualization system for minimally invasive surgery to launch as planned

Viking Systems, Inc. said the launch of its 3DHD Vision System is proceeding as planned.

The company partners with medical device companies and health care facilities to provide urologists and other surgeons with proprietary visualization solutions for complex minimally invasive surgery.

While it is difficult to predict the rate of adoption of any new technology, Viking said the feedback from clinicians to date indicates that the 3DHD Vision System provides superior visualization when compared with current state-of-the-art 2D systems.

Joint licensing deal extended for prostate cancer biomarker

Epigenomics AG, a cancer diagnostics company, and Predictive Biosciences, a developer of novel molecular diagnostic cancer assays and a provider of laboratory products and services, recently announced an extension of their licensing agreement concerning the prostate cancer biomarker GSTP1.

Under the terms of the original agreement, Predictive Biosciences had obtained rights to develop a prostate cancer test incorporating GSTP1 and an option to license GSTP1 for commercialization of the test as a laboratory service. The company has now executed this option, triggering a one-time undisclosed licensing fee to Epigenomics. The diagnostics company is also entitled to future royalties from sales of the test.

According to Predictive Biosciences, the methylation of the GSTP1 gene is well established as a biomarker of prostate cancer, and a test that detects methylated GSTP1 DNA in urine or tissue, in combination with conventional histopathology, may enable a more accurate diagnosis.