Uro Pipeline: FDA grants priority review to sNDA for PCa treatment


Agents for bladder cancer, mixed incontinence, and interstitial cystitis/bladder pain syndrome are also included in this overview of pipeline developments.

FDA grants priority review to sNDA for prostate cancer treatment

Pfizer Inc. and Astellas Pharma Inc. recently announced that a supplemental new drug application (sNDA) for enzalutamide (XTANDI) has been accepted for filing and granted priority review designation by the FDA. If approved, the sNDA would expand the indication of enzalutamide to include men with non-metastatic castration-resistant prostate cancer (CRPC), based on data from the phase III PROSPER trial. Enzalutamide is currently indicated for the treatment of patients with metastatic CRPC. The PROSPER trial evaluated enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in 1,401 patients with non-metastatic CRPC. The study met its primary endpoint, demonstrating that the use of enzalutamide plus ADT significantly reduced the risk of developing metastasis or death compared to ADT alone.

Dosing initiated for clinical trial of muscle-invasive bladder Ca agent

TARIS Biomedical has initiated dosing in a clinical trial of TAR-200 (GemRIS) in patients with muscle-invasive bladder cancer (MIBC) who are unfit for therapy with curative intent. The multicenter, multi-region study intends to enroll subjects with organ-confined, non-metastatic MIBC who are unfit for curative intent therapies. Subjects will be evaluated for safety, tolerability, and evidence of anti-tumor efficacy following four consecutive cycles of TAR-200. Subjects successfully completing this dosing period will then be eligible to receive additional maintenance dose cycles. The company has also engaged in a research collaboration with Uppsala Clinical Research Center and Per-Uno Malmström, MD, PhD, of Uppsala, Sweden. The collaboration will focus on better understanding the natural history and disease outcomes for patients diagnosed with MIBC, through analysis of Sweden’s National Registry of Urinary Bladder Cancer and BladderBaSe disease registries. Dr. Malmström will lead this effort.

Agent shows potential for treating mixed incontinence

GTx, Inc. has announced additional results from a phase II proof-of-concept clinical trial of enobosarm, 3 mg administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients’ pelvic floor muscle. New data in a subset of women also suggest a positive treatment effect of the selective androgen receptor modulator (SARM) for urge incontinence (UI), suggesting a possible treatment effect for women with mixed incontinence, according to GTx. Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment. Treatment with enobosarm also reduced mean UI episodes by approximately 68% in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI. The data were presented at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction winter meeting in Austin, TX.

Next: Database to follow patients undergoing partial-gland HIFU


Database to follow patients undergoing partial-gland HIFU

A consortium of medical institutions is introducing the Focal Robotic Ultrasound Ablation (FoR-UsA) Registry. The new database will track baseline and follow-up information on patients undergoing partial-gland ablation of the prostate using the Ablatherm Robotic High Intensity Focused Ultrasound (HIFU) device, manufactured by EDAP TMS. In related news, EDAP announced that CIGNA became the first major U.S. private health insurance company to reimburse prostate cancer patients who failed radiation and are eligible for HIFU as a salvage therapy. The CIGNA policy covers HIFU as a salvage therapy for patients whose early-stage prostate cancer has not metastasized and who meet both of these criteria: positive, recent (ie, repeat) transrectal ultrasound-guided biopsy completed due to suspicion of local recurrence of prostate cancer; and candidate for local therapy alone as evidenced by all of the following: original clinical stage T1-T2, NX, or N0; recent PSA of less than 10.0 ng/mL; and absence of distant metastases.

Enrollment threshold reached for phase III trial of IC/BPS agent

Aquinox Pharmaceuticals, Inc. has met its enrollment threshold of 300 females in its LEADERSHIP 301 clinical trial of rosiptor (AQX-1125) in interstitial cystitis/bladder pain syndrome (IC/BPS) and remains on track for topline data in the third quarter of 2018. The LEADERSHIP 301 trial is a three-arm, multicenter, randomized, double-blind, placebo-controlled phase III clinical trial assessing the effect of once-daily rosiptor, 100 mg and 200 mg, on bladder pain and urinary symptoms in female and male subjects with IC/BPS. The primary endpoint of the LEADERSHIP 301 trial is the change from baseline at week 12 in maximum daily bladder pain based on an 11-point numeric rating scale compared to placebo, recorded by electronic diary.

Phase IIb study initiated for overactive bladder treatment

Velicept Therapeutics announced the initiation of the first of two phase IIb clinical studies of solabegron in patients with overactive bladder (OAB). The first study (VEL2002) will evaluate two doses of solabegron dosed twice daily in patients with OAB. The primary objective of the study is to evaluate the mean change in number of micturitions per day as measured by patients in an e-diary. Velicept has finalized a novel once-daily formulation of solabegron that will be evaluated in a second study. The formulation was engineered to optimize efficacy in a convenient once-daily dosing. This study (VEL2001) will initiate patient enrollment in the second quarter of this year. Velicept Therapeutics also announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,907,767, which is directed to methods related to the use of solabegron to treat overactive bladder.

Next: Home-based kit provides complete semen evaluation


Home-based kit provides complete semen evaluation

Researchers from Florida Atlantic University’s College of Engineering and Computer Science are developing a home-based kit that they say accurately, quantitatively, and quickly provides a complete semen evaluation using microfluidics, an app, and a smartphone. The user-friendly sperm kit will cost less than $2 per kit to develop and will require one drop of fluid. The kit is being developed to be compatible with all smartphone models. It will consist of a sperm scope, a lens that functions like a microscope that snaps onto the phone, and a microfluidic chamber that will be able to analyze semen at the “micron” scale. Using the app, which will be included in the kit, technology developed at Florida Atlantic will capture, record, and analyze important details about the user’s semen. Easy-to-read results will be available in about 1 minute to inform the user whether he needs to seek further medical attention.

FDA: Topical ED cream NDA not approvable in present form

The FDA has issued a complete response letter for the new drug application (NDA) of alprostadil, DDAIP.HCl (Vitaros), a topical cream for the treatment of erectile dysfunction. The letter indicates that the FDA cannot approve the NDA in its present form, identifying deficiencies related to Chemistry, Manufacturing, and Control and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. Apricus Biosciences, Inc., the agent’s developer, said it is assessing the content of the letter with regulatory experts, including information that may be needed to resolve the deficiencies and the time it would take to obtain such information.

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