Urology drugs and devices in the pipeline.
FDA acknowledges complete response for PCa Rx application
Dendreon Corp. has received written acknowledgement from FDA that its amended biologics license application (BLA) for sipuleucel-T (Provenge) is a complete response. FDA has set May 1, 2010 as the date by which it will respond to the amended BLA.
The BLA includes data from the IMPACT (IMunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with FDA. Dendreon is seeking licensure for sipuleucel-T, a form of active cellular immunotherapy, for the treatment of men with metastatic castrate-resistant prostate cancer.
The new drug application (NDA) for hexaminolevulinate for detection of noninvasive papillary bladder cancer may be approved by FDA pending premarket approval for the Karl Storz photodynamic diagnosis system and final agreements between manufacturer Photocure and FDA on labeling and post-marketing commitments, Photocure announced.
Photocure submitted the NDA on June 30, 2009 and achieved a priority review in August 2009. The company said it expects the pending issues to be agreed upon with FDA within the first half of 2010.
Included in the NDA are phase III study data that showed a significantly improved detection (p=.001) of noninvasive papillary bladder cancer using hexaminolevulinate compared to standard white light cystoscopy.
Development of BPH Rx expands with launch of phase II trial
A phase II clinical trial of talaporfin sodium (Aptocine) for the treatment of BPH is currently under way, Light Sciences Oncology, Inc. announced.
The phase II trial expands the talaporfin BPH development program on the basis of a phase I study at escalating light doses. In the open-label phase II trial, talaporfin is being tested for safety and efficacy in 40 patients with lower urinary tract symptoms due to BPH.
Enrollment now complete for bladder Ca agent's phase III trials
Spectrum Pharmaceuticals has finished enrollment for the second of two phase III trials of apaziquone (EOquin), which is being tested for the treatment of nonmuscle-invasive bladder cancer.
In the double-blind, placebo-controlled trials, patients will be randomized in a 1:1 ratio to apaziquone or placebo. Patients will be given a single 4-mg dose following tumor removal. The primary endpoint is rate of tumor recurrence at year 2.
Phase I/II trial is launched for advanced PCa therapy
Tokai Pharmaceuticals, Inc. recently announced the start of a phase I/II clinical trial of TOK-001 for treatment of castration-resistant prostate cancer.
The trial will assess both safety and efficacy of once-daily treatment in patients with castration-resistant disease. The primary endpoints are safety and reduction in PSA levels from baseline levels measured at first visit.
Patients who respond to TOK-011 will have the opportunity to continue the treatment in an extension arm of the trial, according to the company.