Product Preview

Phase III study to test PDE-5 inhibitor in men with BPH

A phase III study examining the use of the phosphodiesterase type-5 inhibitor tadalafil in men with BPH is planned for 2006. The scheduled trial follows results of a double-blind, placebo-controlled phase II study showing clinically meaningful and statistically significant improvement in lower urinary tract symptoms in men with BPH who were treated for 6 weeks with once-daily tadalafil, 5 mg, according to Lilly ICOS LLC.

In the unpublished study, sponsored by Lilly ICOS , tadalafil elicited statistically significant improvements versus placebo in both the primary endpoint, the seven-item International Prostate Symptom Score questionnaire, and most secondary endpoints. Specifically, patients treated with tadalafil, 5 mg, experienced a mean 2.8-point increase from baseline in IPSS compared with a mean 1.2-point increase in the placebo group. At the end of the initial 6-week period, patients who went on to the once-daily tadalafil, 20 mg, regimen for an additional 6 weeks demonstrated a mean 3.8-point increase from baseline compared with a 1.7-point increase in the placebo group.

Agent earns fast-track status for use in metastatic PCa

Dendreon Corp. has received FDA fast track review status for its proposed use of the investigational active cellular immunotherapy sipuleucel-T (Provenge) for treatment of asymptomatic men with metastatic androgen-independent prostate cancer.

Approval was predicated on the survival benefit demonstrated in the results of recent phase III efficacy studies. The fast track designation allows the manufacturer to submit a U.S. biologics license application on a rolling basis, enabling FDA to review sections of the application in advance of the full submission.

Oral agent granted priority review for use in RCC

Patients whose metastatic renal cell carcinoma has been refractive to standard treatment have received a boost from the FDA. The agency granted priority review status to Pfizer, Inc. for its formulation of sunitinib maleate (Sutent) in metastatic kidney cancer.

Pfizer has 6 months from the New Drug Application filing date to enroll eligible participants in a program to receive the agent at sites throughout the United States, Canada, and Europe. Information is available at 877-416-6248 or by logging on to http://www.pfizeroncology.com/.

Companies set to develop new cryotherapy device

Endocare, Inc. has announced that it will collaborate with refrigeration technology developer CryoDynamics, Inc. on development and commercialization of a next-generation near-critical nitrogen cryoablation system for new clinical applications.

A near-critical system maintains the cryogen in a single phase, eliminating difficulties inherent in using liquid nitrogen while harnessing its powerful freezing capability. Compared with older nitrogen and current Joule Thompson-based argon and nitrous oxide cryo systems, the near-critical system would be faster, safer, less expensive, and more clinically effective, particularly for difficult-to-reach and sensitive tissues, according to Endocare.

The agreement includes the licensing of certain patents and the sharing of licensing and royalty fees.

'Rolling' NDA submission starts for advanced PCa combination

Rolling submission of a New Drug Application has commenced for the investigational platinum agent satraplatin in combination with prednisone as second-line chemotherapy treatment in patients with hormone-refractory prostate cancer.

Satraplatin, manufactured by Spectrum Pharmaceuticals, Inc. and its co-development partner, GPC Biotech AG, holds fast-track designation, and the rolling submission process will expedite review of the application, which is expected to be completed by mid-2006, according to Spectrum.