Product Preview

Fast-track status granted to PCa immunotherapy agent

Cell Genesys Inc.'s GVAX immunotherapy for prostate cancer has been granted fast-track status from the FDA. The product is involved in two phase III trials, which are designed to show survival benefit with GVAX versus docetaxel (Taxotere) plus prednisone (Deltasone, Meticorten, Orasone, et al). The studies involve 1,200 men with metastatic hormone-refractory prostate cancer. Both have received special protocol assessments from FDA.

The VITAL-1 trial will compare GVAX immunotherapy versus docetaxel plus prednisone in chemotherapy-naïve, asymptomatic patients without cancer-related pain; VITAL-2 involves combination therapy of GVAX plus docetaxel versus docetaxel plus prednisone in symptomatic patients who have cancer-related pain. Two previous phase II trials demonstrated survival benefit with GVAX.

Medtronic has announced plans to invest in six new major clinical trials of its neuromodulation and radiofrequency technology therapies during the firm's new fiscal year. These trials will establish class I (risk:benefit) evidence of efficacy and cost-effectiveness with respect to the company's sacral nerve stimulation therapy for treatment of overactive bladder (InterStim) and its transurethral needle ablation therapy for treatment of BPH (Prostiva).

According to the manufacturer, results from the trials will enable physicians to determine which patients will benefit most from these treatment modalities.

Phase III extension begins on ADT side effect therapy

GTx, Inc. has initiated a separate phase IIIb extension of its phase III clinical trial of toremifene citrate (Acapodene), 80 mg, for treatment of the serious side effects of androgen deprivation therapy in men being treated for advanced prostate cancer. The extension will enroll patients from the phase III trial who have completed 2 years of treatment for an additional 12 months to amass efficacy and safety data in support of the phase III trial, scheduled to conclude in late 2007.

Approximately 1,400 men are enrolled in the phase III study, which is being conducted under a Special Protocol Assessment with FDA. Primary endpoint is the overall reduction of vertebral fractures; secondary endpoints include improvements in bone mineral density and cholesterol levels, reduction in hot flashes, and treatment of gynecomastia.

An interim analysis of bone mineral density in the first 200 men to complete a full year of treatment was performed by GTx in late 2005. It found a highly statistically positive change in bone mineral density in patients taking toremifene for the effects of androgen deprivation therapy.

Company earns rights to PCa test development

The University of Michigan has licensed worldwide rights to develop diagnostic tests for prostate cancer-specific genetic translocutions to Gen-Probe Inc.

Gen-Probe will fund research at the university for development of molecular assays that complement its portfolio of prostate cancer diagnostic markers. In addition, it will pay $500,000 in license fees and royalties on eventual product sales and development benchmarks.

Researchers at the university published results in 2005 linking the prostate-specific androgen-responsive gene TMPRSS2 and members of the ETS gene family with the likely development of prostate cancer, a connection that has since been confirmed.

Bladder cancer agent earns fast-track status

The mycobacterial cell-wall-DNA complex (MCC) agent Urocidin has been granted fast-track status by the FDA. In February, FDA granted permission for a phase III open-label clinical trial of MCC in 105 North American patients with non-muscle-invasive bladder cancer refractory to treatment with bacillus Calmette-Guérin (BCG). By issuing fast-track status, FDA may elect to expedite review of the licensing application for MCC after data from this study become available, according to the drug's manufacturer, Bioniche Life Sciences.

In addition to this phase III clinical trial, MCC is being studied in a phase III randomized, double-blind, multicenter study of 630 North American and European patients in non-muscle-invasive bladder cancer with a high risk of recurrence or progression. This trial will compare the agent with BCG, the standard treatment, which has demonstrated treatment-limiting side effects.