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Drugs and devices in the pipeline from Repros Therapeutics, Bavarian Nordic, NxThera, Solace Therapeutics, Generex Biotechnology, Bioniche, OncoCyte, HistoSonics, and Pacific Edge.
Repros Therapeutics Inc. said its investigational oral testosterone formulation (Androxal) exhibited superiority to a leading FDA-approved topical gel (Androgel 1.62) and placebo in the first of two identical studies. Androxal was found superior in the two co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as an individual achieving a 24-hour average testosterone in the normal range with associated average sperm concentration >10 million/mL. Multiple secondary endpoints also showed statistically significant differences between the Androxal and gel groups. These include: change in LH and FSH, percent of subjects who become severely oligospermic, induction of hormone dependence via assessment of morning testosterone levels comparing baseline to 1 week after the end of dosing, and impact on testicular size at the end of the dosing period.
A placebo-controlled clinical trial being conducted at several worldwide sites is examining Bavarian Nordic’s investigational vaccine-based treatment PROSTVAC in patients with metastatic, castration-resistant prostate cancer. The goal of the immunotherapy study is to determine if PROSTVAC improves survival when combined with a drug that helps boost the body’s ability to fight infection, according to Rutgers Cancer Institute of New Jersey, one of the trial sites. Results from a previous clinical trial at the Cancer Institute of New Jersey that examined two forms of PROSTVAC gave researchers information on the safety of using this investigational drug (J Transl Med, Jan. 3, 2006). The new study will further examine how well PROSTVAC does in improving survival outcome in patients with metastatic prostate cancer. PROSTVAC-V is derived from a vaccinia virus that was used for many years to vaccinate against smallpox. PROSTVAC-F is made from the fowlpox virus, which is found in birds and not known to cause any human disease.
NxThera has completed enrollement in its Rezum II IDE clinical trial for the treatment of BPH. The trial evaluated use of the Rezum system to treat obstructive prostate tissue by convectively delivering sterile water vapor, or steam, directly into the prostate in a minimally invasive procedure that can be performed in a matter of minutes, NxThera said. The U.S. multicenter study enrolled 195 men age 50 years or older, who were randomized 2:1 to treatment with the Rezum system versus a control procedure.
Solace Therapeutics, Inc. has begun patient enrollment in a clinical trial to assess the safety and effectiveness of the Solace Bladder Control Balloon System in women who experience urine leakage during times of physical movement. Known as SUCCESS (Stress Urinary InContinence Control Efficacy and Safety Study), the randomized, multicenter, controlled trial is anticipated to enroll 220 women at up to 20 clinical sites across the United States. The study endpoints evaluate women’s improvement in quality of life and reduction in urine leakage. The SUCCESS trial is Solace Therapeutics’ third randomized, controlled study to evaluate this treatment option.
Generex Biotechnology Corp. announced publication of a follow-up study from a phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer. The study demonstrates an association between a specific immune response generated by AE37 and improved overall survival, as reported online in Cancer Immunology, Immunotherapy (July 23, 2014). While a prior study showed that AE37-immunized patients had better overall and disease-free survival as a group than would be expected from their disease status, the current study shows that patients with the strongest immunologic response fared best. In particular, both the presence of AE37-induced T cells in peripheral blood and a robust delayed-type hypersensitivity response elicited by AE37 correlated significantly with overall survival.
Bioniche has submitted to the FDA an application for organ drug designation for its Mycobaterial Cell Wall-Nucleic Acid (MCNA) Complex sterile suspension for the treatment of patients with bacillus Calmette-Guérin-refractory/relapsing high-grade nonmuscle-invasive bladder cancer. If approved, the designation of MCNA as an orphan drug will give the company a 7-year period of market exclusivity in the U.S. and a waiver to certain filing fees.
OncoCyte Corp. has expanded the clinical development of its urine-based bladder cancer diagnostic test by initiating a multi-site clinical trial. The trial, which will involve up to 1,200 patient samples obtained from at least four large urology clinics located throughout the United States, has received Institutional Review Board approval at multiple sites and was scheduled to begin enrolling patients in August 2014. OncoCyte’s initial study of the PanC-Dx test began in January and involves pathology specimens being collected at a leading medical institution. The multi-site trial is designed to expand the potential use of the test beyond pathology laboratories and into urology practices at the point of cystoscopy. The goal of the current clinical trial is to compare the performance of OncoCyte’s proprietary PanC-Dx bladder cancer markers to the performance of cystoscopy.
Research has begun on the development of a safe, noninvasive treatment for BPH. The experimental Vortx Rx device from HistoSonics, Inc. is based on histotripsy technology, a non-thermal focused ultrasound therapy that mechanically liquifies targeted tissues. Vortx Rx treatment involves using high-intensity sound waves like an acoustic scalpel to break down targeted cells into a liquid that leaves the body during urination. A U.S. pilot clinical study will enroll a limited number of men with BPH symptoms at trial sites including ProMedica and the University of Michigan in Ann Arbor. The primary goal of this pilot study is to demonstrate safety of the Vortx Rx in the treatment of BPH, ProMedica said.
Pacific Edge Ltd signed an agreement with Southern California Permanente Medical Group to research its user program to evaluate its Cxbladder bladder cancer technology within the clinical settings of Kaiser Permanente’s health care network. The Kaiser user program research project is scheduled to recruit approximately 2,000 patients presenting with microscopic and macroscopic hematuria. Cxbladder is designed to provide clinicians with a means to identify patients with a high degree of surety who do not have bladder cancer so as to avoid further expensive clinical workup, according to Pacific Edge. The user program research is scheduled to begin later this year, with results completed in early 2015.UT
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