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.