medical research

RDD Pharma Awarded CDMRP Grant for Clinical Drug for SCI Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application.  The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK.  “We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  “We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population.”  Read more.

Source: PRNewswire, September 14, 2017

Florence Italy ICS 2017

GTx Announces Positive Results from Enobosarm Phase 2 Clinical Trial

GTx, Inc. (Nasdaq: GTXI) today announced top-line clinical trial results demonstrating that a daily dose of enobosarm 3 mg (GTx-024) substantially improved stress urinary incontinence (SUI) in women, as well as related quality of life measurements. In this open-label clinical trial, all 17 patients completing 12 weeks of treatment saw a clinically significant reduction (50 percent or greater) in stress leaks per day, compared to baseline. Mean stress leaks decreased by 83 percent from baseline over 12 weeks, and the reductions in daily stress leaks following completion of treatment have been sustained as patients are being followed for up to 7 months post-treatment to assess the durability of treatment effect. No patient has relapsed to her baseline levels. These results were presented at the International Continence Society (ICS) Annual Meeting currently being held in Florence, Italy from September 12-15, 2017. Read more.

Source: Business Wire, September 13, 2017

doctor and patient

Trendlines Gets Grant for Urinary Incontinence Device

Trendlines Labs is to receive a grant from the Singapore Israel Industrial Research and Development Foundation for the development and clinical trial of its stress urinary incontinence (SUI) product, which is being developed in partnership with the Singapore General Hospital.  The 50 women in the trial, expected to start mid-2017 at the hospital, will provide feedback on the product. The foundation will provide up to 50 percent of the $400,000 the partners need to fund the final product development and clinical trial.  Trendlines Labs, the innovation arm of The Trendlines Group Ltd., the Israeli venture fund and tech accelerator firm, has developed a nonsurgical, non-pharmaceutical solution to mitigate SUI, a form of incontinence that affects approximately 15 million women in the US alone, according to the Women’s Health Foundation. SUI is caused by weak sphincter muscles or weak pelvic floors, and can occur when there is abdominal stress on the pelvic organs — the bladder, vagina, uterus, or rectum. Read more.

Source: Times of Israel, April 3, 2017

operating room

StimGuard Enrolls First Patient in Office-Based Chronic Tibial Nerve OAB Incontinence Stimulation Study Utilizing the World’s Smallest Wireless System

StimGuard, a privately-held, pre-commercial stage medical device company, today announced the initiation and the first patient enrollment in a clinical trial of the world’s first miniature implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The StimGuard device utilizes wireless technology and is placed through an introducer device the size of a needle at the tibial nerve to activate the afferent micturition (neural urinary) pathways. The clinical trial of this novel approach will launch this winter. Read more.

Source: Business Wire, December 15, 2016

medical research

Cytori Pivotal ADRESU Incontinence Trial Hits 50% Enrollment Milestone

Cytori Therapeutics, Inc. (CYTX) today announced that over half of 45 patients in the ADRESU trial in Japan have been enrolled and treated. ADRESU is a late phase, investigator-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell TherapyTM in men with stress urinary incontinence after prostatic intervention for prostate cancer or benign prostatic hypertrophy. Read more.

Source: Yahoo! Finance, December 14, 2016