Ben Schwartz is Associate Editor, Contemporary OB/GYN.
Other pipeline developments discussed include an implantable device for OAB treatment, a subcutaneous hypogonadism treatment, efficacy results for an HPV drug, and the status of a device-based BPH treatment.
FDA accepts Biologics License Application for bladder Ca agent
AstraZeneca, along with its research and development branch, MedImmune, has received a Biologics License Application (BLA) from the FDA for the investigational agent durvalumab. The BLA submission is for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after a platinum-based regimen. Durvalumab, a PD-L1 human monoclonal antibody (mAb), was also was granted priority review status with a Prescription Drug User Fee Act date set for the second quarter of 2017. In the phase III DANUBE trial, durvalumab is being tested both as a monotherapy and in combination with tremelimumab (CTLA-4 mAB).
Enrollment for trial of device-based BPH treatment completed
PROCEPT BioRobotics has completed enrollment for a phase III study of its AquaBeam System for the treatment of BPH. The Waterjet Ablation Therapy for Endoscopic Resection (WATER) study enrolled 184 male patients between the ages of 45 and 80 years old who have urinary symptoms resulting from BPH. The study evaluates the efficacy of the AquaBeam System as compared to transurethral resection of the prostate. The system uses surgical robotics along with real-time prostate imaging to deliver the Aquablation therapy. In the procedure, a targeted, heat-free waterjet is used to immediately remove prostate tissue to treat lower urinary tract symptoms caused by BPH. The imaging helps the surgeon to draw a treatment contour that conforms to the shape of the prostate adenoma so that it does not interfere with anatomic markers responsible for continence and ejaculatory function. The study is being performed at 17 sites across four countries.
Trial begins for miniature implantable device for OAB treatment
StimGuard has enrolled its first patient in a clinical trial of a miniature implantable device for the treatment of urgent urinary incontinence due to overactive bladder syndrome. The device uses wireless technology and is placed through a needle-sized introducer at the tibial nerve to activate the afferent micturition pathway. StimGuard’s “PROTECT” Study is a randomized, controlled study that compares the efficacy of the device with a recurring treatment. Using ultrasound guidance, the device is implanted at the tibial nerve, and an externally worn transmitter provides energy and to the device at night. The trial includes approximately 242 patients and will commence this winter.
NDA submitted for subcutaneous hypogonadism treatment
Antares Pharma, Inc. has submitted a new drug application for QuickShot Testosterone (QST), an investigational drug-device combination product that uses a subcutaneous auto injector to deliver testosterone enanthate. The product is intended for the treatment of hypogonadism. The QST phase III study consisted of a 1-year pivotal safety and efficacy study plus a second 6-month safety study involving 283 men. Patients involved received 75 mg of testosterone enanthate once weekly for 6 weeks. Blind dose adjustments were made after week 7, and the patients received subcutaneous doses of 50 mg, 75 mg, or 100 mg of testosterone weekly for up to 52 weeks.
Phase II data suggest drug’s efficacy in HPV-related genital warts
Novan has released the results of its phase II clinical trial on SB206 for the treatment of genital warts caused by human papillomavirus (HPV). In the randomized, double-blind, vehicle-controlled trial, the safety and efficacy of the drug were evaluated in 107 patients with external genital warts and perianal warts. The primary endpoint was the proportion of patients who were completely clear of warts that were present at baseline at or before week 12. When treated with SB206 12% once daily, 33% of patients achieved clearance compared to 4% of patients treated with vehicle once daily. Cutaneous tolerability was monitored throughout the study, and the most frequently reported treatment-emergent adverse reactions were application site reactions. Novan expects to continue conversations on SB206 with the FDA in the first half of 2017 and depending on phase II results will initiate phase III trials in the second half of the year.
Erectile dysfunction treatment receives broad patent coverage
Can-Fite BioPharma, Ltd. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application regarding A3 adenosine receptor (A3AR) ligands for use in the treatment of erectile dysfunction. The patent focuses on methods of treatment for erectile dysfunction with different A3 adenosine receptor ligands, including Can-Fite’s erectile dysfunction drug, CF602. CF602 is an allosteric compound that showed effects on erection superior to sildenafil citrate (Viagra) in diabetic animal studies, Can-Fite said. In February 2016, the company received a Notice of Allowance addressing composition of matter for allosteric compounds. CF602 is being prepared for an IND submission to the FDA and a phase I trial.
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