Products in the pipeline for prostate cancer, bladder cancer, stress urinary incontinence, chronic prostatitis/chronic pelvic pain syndrome, hypoactive sexual desire disorder.
Liquid biopsy accurately identifies high-grade prostate cancer
Exosome Diagnostics, Inc. recently announced positive data from an initial clinical study of the company’s novel prostate cancer liquid biopsy. The noninvasive, RNA-based test demonstrated the potential to accurately predict high-grade prostate cancer by analyzing biomarkers on exosomal RNA via a urine sample. The prostate cancer liquid biopsy is being developed to noninvasively assess the risk for high-grade prostate cancer in men with an elevated gray zone PSA (2.0–10.0 ng/mL). The data were presented at the Genitourinary Cancers Symposium in Orlando, FL.
Maker of HIFU device to pursue direct de novo 510(k) clearance
Based on a recent meeting with the FDA, EDAP TMS SA says it plans to seek clearance of Ablatherm high-intensity focused ultrasound by way of a direct de novo 510(k) application as opposed to the pre-market approval application amendment the company had been pursuing. The FDA indicated that while pre-market approval would be required for specific claims regarding treatment of prostate cancer, a prostate tissue ablation claim could be cleared via a direct de novo 510(k) application.
Southern Illinois University awarded grant to develop ED prosthesis
The division of urology at Southern Illinois University School of Medicine, Springfield has received a $65,868 grant from American Medical Systems, Inc. to support the development of a novel physiologic prosthesis for the treatment of erectile dysfunction. Kevin McVary, MD, and Alberto Colombo, PhD, of the Southern Illinois division of urology are leading the development of the device, according to a news release from the university.
Companies announce agreement on prostate cancer immunotherapy
Bavarian Nordic and Bristol-Myers Squibb Co. have entered into an agreement that provides Bristol-Myers Squibb an exclusive option to license and commercialize PROSTVAC, Bavarian Nordic’s investigational phase III PSA-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Under terms of the agreement, Bavarian Nordic will receive an upfront payment of $60 million, the companies announced. Bristol-Myers Squibb can exercise the option in its sole discretion within a designated time after data are available from the ongoing phase III trial.
Company issues updates on agents for early, advanced prostate Ca
Madison Vaccines Inc. (MVI) announced that plans are progressing for three projects in early, advanced, and late-stage prostate cancer. Two additional sites have opened enrollment for the phase II clinical trial for MVI’s lead product candidate, MVI-816, in non-metastatic prostate cancer; the company has selected and will procure a PD-1 inhibitor for a combination trial with MVI-816 in late-stage prostate cancer; and the FDA has approved a phase I investigational new drug application for MVI-118, MVI’s new vaccine to address treatment resistance and disease progression in advanced prostate cancer.
SUI system yields statistically significant decrease in leakage
Data from a multicenter, 63-patient randomized controlled trial of the Vesair Bladder Control System have met study endpoints with statistical significance, Solace Therapeutics, Inc. reported. The Vesair is a novel, office-based, reversible treatment designed to reduce or eliminate urine leakage in female patients with stress urinary incontinence. Study results demonstrated statistical significance of at least a 50% decrease in urine leakage volume and a 10-point improvement in quality of life score in an intent-to-treat population. Data from the study were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction winter meeting in Scottsdale, AZ.
Toxicology studies initiated for prostate cancer agent
Aduro Biotech, Inc. has achieved its first milestone under its collaboration with Janssen Biotech, Inc., by initiating toxicology studies to support an investigational new drug application for ADU-741, an immuno-oncology product candidate for the treatment of prostate cancer. The Janssen decision to advance ADU-741 toward clinical trials was based on preclinical data generated in the first 8 months of the collaboration. This accomplishment triggered a milestone payment to Aduro, the company announced.
In May 2014, Aduro entered into an agreement granting Janssen an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on Aduro’s proprietary platform of live, attenuated, double-deleted Listeria monocytogenes strains that have been engineered to initiate a powerful innate immune response and drive a targeted, durable adaptive immune response.
Bladder cancer test sucessful IDs cancerous cells in urine samples
Micromedic Technologies Ltd.’s CellDetect noninvasive technology to detect bladder cancer recurrence in patients with a history of the disease successfully identified cancerous cells in urine samples, according to recently reported study results. The test had a sensitivity of 84.4% and specificity of 82.7% for the study’s primary endpoint. The secondary endpoint showed that the sensitivity of other noninvasive comparator tests-urine cytology, BTA stat, and NMP22 BladderCheck-was 50.0%, 68.8%, and 17.4%, respectively. The company says it plans to secure a CE mark approval for a European launch of the test later this year as well as to submit a pre-investigational device exemption to the FDA.
Two firms enter agreement to develop agent for CP/CPPS
Insys Therapeutics, Inc. has entered into an exclusive sub-license agreement with Gold Coast Therapeutics to develop a unique combination of Cromolyn Sodium and Cetirizine as a new chemical entity for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Data from preclinical studies conducted at Northwestern University, Chicago implicate mast cells as mediators of chronic pelvic pain associated with the prostate, and demonstrate that mast cell markers are elevated in men with CP/CPPS. Design is underway for preclinical studies and clinical trials studies to be conducted at Northwestern University/Northwestern Medicine.
New drug application resubmitted for female sexual dysfunction agent
Sprout Pharmaceuticals has resubmitted a new drug application to the FDA for flibanserin, an investigational, once-daily, non-hormonal pill for hypoactive sexual desire disorder (HSDD) in premenopausal women. The resubmission comes after Sprout received a complete response letter from the FDA for flibanserin in 2013. The company appealed the FDA’s decision, and at the request of the agency, completed a phase I pharmacokinetic study and a phase I driving study. Results from these studies were included in the resubmission package. If approved, flibanserin will be the first and only FDA-approved treatment for HSDD, according to a press release from Sprout.
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