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Pivotal BPH drug trial earns committee go-ahead

The Independent Data Monitoring Committee for the phase II trial of Nymox Pharmaceuticals' NX-1207, a novel drug treatment for BPH, has recommended continuation of the multicenter trial on the basis of unblinded re-sults to date.

In previous phase I and II trials, NX-107 demonstrated statistically significant overall mean symptom improvement-10 points on the BPH Symptom Score-and average shrinkage in prostate size of 23.4% after 1 month. No serious adverse events and no sexual side effects have been seen in two previous trials.

Epigenomics AG of Berlin has successfully completed a 7-year study validating the role of three biomarkers as indicators of prostate cancer aggressiveness. In addition, the firm has announced development of the test as its own product, rather than as a collaborative effort with Roche Diagnostics.

The study validated three DNA methylation markers on 605 prostate cancer samples obtained during radical prostatectomies at three U.S. centers between 1993 and 2000. The markers are statistically significant designators of prognosis-more so than Gleason score, tumor stage, or PSA-and can be used to identify patients with poor prognosis who might benefit from adjuvant treatment after surgery, according to Epigenomics. Further development is under way for use with needle biopsy samples to detect early-stage prostate cancer.

Companies plan to market bladder Ca imaging agent

GE Healthcare has signed a licensing agreement with Norwegian pharmaceuticals manufacturer PhotoCure ASA that assigns global marketing and distribution rights outside of the United States and Scandinavia to market an optical molecular imaging agent for diagnosing and monitoring bladder cancer.

ProCure's hexaminolevulinate (Hexvix) is approved for diagnosis of bladder cancer in several European countries, but has not yet been approved for use in the United States. However, a new drug application was submitted to the FDA in June 2005. FDA approval would make hexaminolevulinate the first optical molecular imaging agent of its kind in the United States, GE Healthcare said. Under the licensing agreement, GE Healthcare would have exclusive U.S. marketing and distribution rights.

Prostate Ca drug moves into phase II trials

Two ongoing phase II studies of OncoGenex' second-generation antisense drug OGX-011 will study the effectiveness of the agent in combination with neoadjuvant hormone therapy and also in combination in two different prostate cancer patient populations.

A randomized phase II study will assess the efficacy and safety of OGX-011 with docetaxel (Taxotere) and prednisone versus docetaxel and prednisone alone in patients with metastatic or locally recurrent hormone-refractory prostate cancer.

A separate phase II study will assess the combined effects of OGX-011 and neoadjuvant hormone therapy on complete response rates in patients with localized prostate cancer and high risk factors. This study will assess clusterin expression in residual prostate cancer, safety and toxicity of therapy prior to radical prostatectomy, time to PSA nadir, and PSA recurrence after therapy.

According to the manufacturer, three phase I studies have shown OGX-011 inhibits clusterin in cancer cells by >90%, inhibits clusterin expression in lymph nodes by >95%, and is well tolerated.

Agreement forged to create real-time imaging system

Urologix, Inc., ProUroCare Medical, Inc., and Rensselaer Polytechnic Institute have entered into a co-development agreement to create a real-time temperature imaging system, ProUroVision, that can be paired with Urologix' Cooled ThermoTherapy treatment for benign hyperplasia and other possible indications.

The goal is to develop a device that takes real-time discrete temperature measurements at several sites in the prostate during the procedure and shows both the heating effect and associated tissue necrosis from the therapy.