Urology Product Preview: Testosterone agent meets efficacy endpoint in phase III studies


Drugs and devices in the pipeline form Clarus Therapeutics, Nymox Pharmaceutical, Bioniche Life Sciences, Repros Therapeutics, BioLight Life Sciences Investments/Micromedic Technologies, Cubist Pharmaceuticals, Takeda Pharmaceutical, H. Lundbeck A/S, Transplant Genomics, Orion, Bayer, and Roche.

Testosterone agent meets efficacy endpoint in phase III studies

Clarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral testosterone undecanoate (REXTORO) for testosterone replacement therapy in men with hypogonadism. Each trial differed in design, dose-titration algorithm, and duration. Each demonstrated T replacement, and with the revised dose-titration algorithm, the maximum serum T concentration was comparable to other T replacement therapies. The agent met the efficacy endpoint in both studies, said Clarus Therapeutics CEO Robert E. Dudley, PhD, in a press release. The studies were presented at the International Congress of Endocrinology and the Endocrine Society’s Annual Meeting and Expo in Chicago.

Repeat injection of BPH agent improves AUA Symptom Index Score

Nymox Pharmaceutical Corp. announced positive efficacy data from its phase III NX02-022 repeat injection study of NX-1207 for BPH. The company reported that analysis of symptomatic improvement from repeat injection over a 1- to 2-year period showed a mean improvement of 8.2 points in AUA BPH Symptom Index Score. Evaluation of safety data confirmed that NX-1207 reinjection treatment was well tolerated and did not impair sexual function. In addition, NX-1207 reinjection treatment has not shown any drug-related significant side effects, Nymox said in a press release.

FDA permits submission of license application for bladder cancer Tx

Bioniche Life Sciences Inc. has received written guidance from the FDA that permits the submission of a biological license application (BLA) for U.S. marketing approval of the company’s Mycobacterial Cell Wall-Nucleic Acid Complex sterile suspension for the treatment of patients with bacillus Calmette–Guérin-refractory high-grade nonmuscle-invasive bladder cancer. The permission was granted based on Bioniche’s existing clinical trial data set, the company said. In preparation for submitting the BLA, the company has engaged a global regulatory consulting firm that will help in the review and final submission of the BLA.

FDA proposes co-primary endpoints for testosterone agent trials

The FDA has provided additional guidance to Repros Therapeutics regarding primary endpoints for the studies of Androxal that the company is currently conducting. The studies are comparing Androxal to the leading approved testosterone gel and placebo. Androxal is being developed for men of reproductive age with low testosterone due to secondary hypogonadism. The FDA proposed three co-primary endpoints: percentage change from baseline in sperm concentration comparing Androxal to the leading U.S. testosterone replacement therapy; proportion of men obtaining a testosterone level in the normal range; and percentage of men who exhibit sperm ≥10 million/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal to a testosterone gel as well as comparing Androxal to placebo.


Next: Products for bladder Ca, infection, sexual dysfunction


Successful interim results reported for bladder Ca detection technology

BioLight Life Sciences Investments Ltd. recently reported that Micromedic Technologies, BioLight’s cancer diagnostic cluster company, achieved successful interim results in a blinded bladder cancer clinical trial with its CellDetect technology. As a result, Micromedic said it will continue the trial, with the goal of developing a kit for monitoring the recurrence of bladder cancer. The study is being conducted at seven centers and is expected to be completed in the fourth quarter of 2014, BioLight reported in a press release.

FDA accepts NDA for infection Tx, grants priority review designation

The FDA has accepted Cubist Pharmaceuticals’ new drug application for its investigational antibiotic ceftolozane/tazobactam with priority review, the company said. The FDA assigned a Prescription Drug User Fee Act action date of Dec. 21, 2014. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. The NDA is based on positive data from two pivotal phase III clinical trials of the agent in complicated urinary tract infections and complicated intra-abdominal infections. The studies met FDA and European Medicines Agency-specified primary endpoints, according to Cubist.

Study: Antidepressant significantly improves sexual dysfunction

Takeda Pharmaceutical Co. and H. Lundbeck A/S announced the presentation of results about sexual functioning from a head-to-head study of its antidepressant vortioxetine (Brintellix) versus escitalopram (Lexapro) in patients with well-treated major depressive disorder experiencing treatment-emergent sexual dysfunction. The results, which were presented at the American Society of Clinical Psychopharmacology annual meeting in Hollywood, FL, demonstrated that patients treated with vortioxetine experienced a statistically significant improvement, with a mean treatment difference of 2.2 points (95% CI: 0.48–4.02) in Changes in Sexual Functioning Questionnaire Short Form total score after 8 weeks of treatment (p=.013) compared to escitalopram.

Company to develop tests to improve transplant outcomes

Transplant Genomics Inc. has obtained an exclusive license to patent rights co-owned by the Scripps Research Institute and Northwestern University that provide the foundation for clinical tests to improve management of organ transplant recipients, with the potential to extend lives and reduce costs of associated health care. In a press release, Transplant Genomics said it intends to develop and commercialize tests that use genomic markers of transplant graft status as part of a surveillance program to detect and respond to early signs of graft injury.


Next: Products for prostate cancer, bladder cancer


Orion, Bayer enter into partnership for investigational PCa compound

Orion Corp. has entered a global partnership with Bayer for the development and commercialization of the compound ODM-201, an investigational androgen receptor inhibitor for the treatment of patients with prostate cancer. The companies will jointly start a phase III program to further evaluate the effficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer in 2014.

Agent shrinks bladder tumors in 43% of patients in early trial

Results from a phase I open-label study showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumors (overall response rate) in 43% of patients previously treated for metastatic urothelial bladder cancer whose tumors were characterized as PD-L1 (Programmed Death Ligand-1) positive by a test being developed by Roche. Adverse events were consistent with what has been previously reported for the immunotherapy, Roche said in a press release. The FDA has granted MPDL3280A Breakthrough Therapy Designation. Results of the study were presented at the American Society of Clinical Oncology annual meeting in Chicago.

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