Saylor is content managing editor for Urology Times.
A novel oral TRT agent, bladder control system, and localized prostate cancer agent are among other treatments in the pipeline discussed in this round-up.
Trial launched for drugs’ use in metastatic, hormone-sensitive PCa
Astellas Pharma Inc. and Medivation, Inc. recently announced the launch of the ARCHES (AR Inhibition with ChemoHormonal Therapy in Men with MEtastatic Castrate Sensitive Prostate Cancer) phase III registrational trial. The study, which will evaluate the efficacy and safety of enzalutamide (XTANDI) with androgen deprivation therapy (ADT) versus placebo with ADT in metastatic hormone-sensitive prostate cancer (mHSPC) patients, has been initiated and the first patient has been randomized. The global, randomized, double-blind, placebo-controlled study, which is being led by Astellas, will enroll approximately 1,100 patients with mHSPC at approximately 250 centers globally. The primary endpoint is radiographic progression-free survival, defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review or death, whichever occurs first.
Agreement reached to investigate efficacy of PCa detection cameras
Aytu BioScience, Inc. has entered into a study agreement with Hybridyne Imaging Technologies to investigate the efficacy of Hybridyne’s ProxiScan compact gamma cameras to detect local prostate cancer using ProstaScint, Aytu’s imaging agent. The study is being conducted at The Princess Margaret Cancer Centre in Toronto, and supported by Hybridyne. As part of the agreement, Hybridyne will purchase ProstaScint for the study.
Data for novel oral TRT agent presented at scientific meeting
Clinical data for LPCN 1021, an oral testosterone replacement therapy product candidate being developed for adult males with hypogonadism, were presented at the American Society of Andrology annual meeting in New Orleans. LPCN 1021 is a novel twice-a-day oral testosterone replacement therapy product candidate that is designed to help restore normal testosterone levels in hypogonadal men. The agent demonstrated positive efficacy and safety results in phase III testing and has a new drug application under review with the FDA, according to developer Lipocine Inc.
Patient enrollment begins for phase II trial of prostate cancer treatment
Arno Therapeutics has enrolled the first patient in the second stage of its phase I/II clinical trial evaluating onapristone in men with advanced castration-resistant prostate cancer (CRPC) after failure of abiraterone (ZYTIGA) or enzalutamide (XTANDI). The phase II portion of this study will evaluate onapristone in combination with abiraterone in patients with CRPC. Stage 2 of the study also includes a phase II cohort of patients with CRPC who will receive single-agent onapristone. Onapristone is an oral, anti-progestin hormone blocker that has been shown in previous phase II clinical trials (not sponsored by Arno) to exhibit anti-tumor activity in patients with breast cancer, according to the company.
Bladder control system shows efficacy at 6 months
Stefan De Wachter, MD, PhD, recently presented 6-month data from a trial of the Vesair Bladder Control Baloon during the European Association of Urology annual congress in Munich, Germany. The poster presentation included 6-month data from the SOLECT Trial that had been collected from ongoing follow-up of patients enrolled in Solace Therapeutics, Inc.’s second randomized controlled trial of the Vesair system. The results demonstrate that patients continue to experience clinically relevant efficacy in the reduction of urine leakage, episode frequency, and improved quality of life 6 months after receiving the balloon, according to Solace Therapeutics.
Breakthrough therapy designation granted for bladder cancer Tx
The FDA has granted breakthrough therapy designation for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1-positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen, according to AstraZeneca and MedImmune, its global biologics research and development arm. The designation for durvalumab was granted by the FDA on the basis of early clinical data from a phase I trial (Study 1108) in patients with advanced metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.
Phase II results announced for localized prostate cancer agent
Nymox Pharmaceutical Corp. recently announced results from the completion of the company’s U.S. 40-month (18-month outcomes) localized prostate cancer phase II NX03-0040 clinical trial of fexapotide triflutate (NX-1207). The study successfully met its pre-determined endpoints. Cancer progression clinical outcomes were significantly improved in the fexapotide-treated patient groups, Nymox reported.
Phase III efficacy, safety results announced for T injection
Antares Pharma, Inc. announced 12-week efficacy and 52-week safety results from the phase III clinical study (QST-13-003) evaluating testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot (QS) auto injector in testosterone-deficient adult males. In the overall analysis for efficacy, the primary endpoint of the population that received one or more doses of QS T was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range.
Trial to evaluate agent in obese hypogonadal males
Repros Therapeutics Inc. has fully randomized a phase II double-blind placebo-controlled proof of concept study of enclomiphene in conjunction with rigorous diet and exercise in the treatment of obese secondary hypogonadal men. In the ongoing double-blind placebo-controlled proof-of-concept study, rigorous diet and exercise with or without enclomiphene will be evaluated to determine how quickly obese men can achieve sustainable improvements in metabolic parameters. The study will be 15 months in length and consist of three phases.
Enrollment stopped for monotherapy arm of bladder cancer agent
Heat Biologics, Inc. has announced that it will no longer enroll new patients in its phase II monotherapy trial arm evaluating HS-410 alone for the treatment of nonmuscle-invasive bladder cancer. Heat Biologics added the monotherapy trial arm in response to the intermittent global shortage of standard of care bacillus Calmette-Guérin (TheraCys, TICE BCG) in early 2015. The shortage has since then been resolved and as such, Heat Biologics will no longer enroll new patients in this trial arm based on discussions with the FDA. The decision does not relate to concerns regarding the safety profile of HS-410. Heat Biologics said it anticipates reporting topline 6-month data from these 16 patients in the fourth quarter of 2016, contemporaneous with reporting data from the company’s BCG combination cohorts.
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