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May 15, 2006

A second phase III trial of Bioniche Life Science's proprietary mycobacterial cell wall-DNA complex (MCC [Urocidin]) has been given the green light by FDA. The double-blind study will randomize approximately 630 patients at sites in North America and Europe comparing the agent to bacillus Calmette-Guerin as first-line therapy in superficial bladder cancer at high risk of recurrence or progression.

Bladder cancer drug enters second phase III trial

A second phase III trial of Bioniche Life Science's proprietary mycobacterial cell wall-DNA complex (MCC [Urocidin]) has been given the green light by FDA. The double-blind study will randomize approximately 630 patients at sites in North America and Europe comparing the agent to bacillus Calmette-Guerin as first-line therapy in superficial bladder cancer at high risk of recurrence or progression.

The drug is formulated from Mycobacterium phlei, a non-pathogenic strain of mycobacteria that has demonstrated immune stimulatory and apoptotic activity against cancer cells. The agent is a sterile biologic composition in a sub-micron suspension, and, unlike BCG, it is not classified as a biohazard.

Enrollment in the two studies, which will run concurrently, will open in mid-2006.

Novel GnRH blocker for Pca moves into phase III trials

Buoyed by outcomes from a multicenter phase IIb study of its novel gonad-otropin-releasing hormone blocker, degarelix, in prostate cancer, Ferring Pharmaceuticals announced it would commence phase III trials of the agent.

Degarelix, a synthetic peptide, blocks GnRH agonists from binding to receptors in pituitary gland cells and stimulating release of luteinizing hormone and subsequent testosterone and PSA production. By blocking the testosterone surge coincident with prostate cancer treatment, symptoms and tumor growth are suppressed, and the need for anti-androgen treatment is eliminated.

Results from the year-long phase IIb study of 187 men with histologically confirmed prostate cancer and PSA ≤2.0 ng/mL showed that an initial subcutaneous dose of degarelix, 240 mg followed at 28-day intervals with maintenance doses of 80 mg, 120 mg, or 160 mg, suppressed testosterone levels to ≤ 0.05 ng/mL in 92% of patients at day 3 and 95% at day 28. Among those who received a maintenance dose of degrelix, 160 mg at day 28, 100% of patients achieved and maintained testosterone levels of ≤0.05 ng/mL through day 364 of the study. No testosterone surge was detected.

Prostate Ca biomarkers gain provisional patent filing

Genetic diagnostics research firm Upstream Bioscience, Inc., has announced provisional patent filing of prostate cancer genetic markers that could be used to develop diagnostic tests to complement current PSA screening tests. The company said it hopes to create a test that would identify genetic indicators of men with an elevated risk for developing prostate cancer, potentially enabling cancer detection in its earliest stages.

Prostate Ca trial combines novel agent with docetaxel

ASCENT-2, a large phase III study, has been launched by Novacea, Inc., to investigate the efficacy of combining the company's novel oral anticancer agent DN-101 and docetaxel (Taxotere) in men with prostate cancer for whom hormone therapy no longer is effective.

The randomized, controlled, multicenter study will enroll 900 patients from more than 125 medical centers in North America and Europe, and follows on the heels of the 250-patient phase II ASCENT trial that showed improved survival and reduced incidence of chemotherapy-induced side effects in patients receiving DN-101.

DN-101 is an oral, dose-intense formulation of calcitriol, the most potent ligand for the vitamin D receptor, according to the manufacturer. DN-101 binds to the vitamin D receptor and triggers cellular pathways to stop cancer growth, resulting in apoptosis.

Patients in the investigational arm of ASCENT-2 will receive DN-101, 45 mg, on day 1 followed by standard docetaxel therapy on day 2, repeated weekly for 4 weeks.

Survival is the primary endpoint; reduction of skeletal-related and thromboembolic adverse events will be measured as the secondary endpoint.

Companies settle dispute over drug for OAB

Schwarz Pharma AG, has agreed to an exclusive world-wide license agreement with Pfizer, Inc. for Schwarz's antimuscarinic drug, fesoterodine. The settlement ends all patent claims and disputes over rights to the drug, which is being investigated for the treatment of overactive bladder.