“Fexapotide has the real potential to alter the way BPH will be treated in the future,” Dr. Paul Averback, CEO of Nymox, said in a press release. “There is a major unmet medical need for a safe and efficacious treatment method for the many men who suffer from this age-related malady. This first filing represents a major corporate milestone for the development of Fexapotide.”
Fexapotide triflutate (NX-1207) is a novel drug urologists can administer in a quick office procedure that requires no anesthesia or catheterization, and causes little or no pain or discomfort. In clinical trials, the drug improved BPH symptoms, reduced the need for BPH surgery, cut the risk for prostate cancer, and offered an excellent long-term safety profile with no sexual side effects in comparison to available drug treatments.
Last year, Nymox reported that an analysis of clinical trials showed that BPH patients initially treated with fexapotide triflutate had significant clinical benefits in as early as 10 days, compared with men on placebo or those who had undergone previous treatments.
On its website, Nymox says that while the U.S. Phase 3 clinical studies failed to reach their primary endpoints, they did show excellent safety and efficacy at six months and longer, which were consistent with previous successful fexapotide studies.
“Going forward, we expect to announce further regulatory filings for approval in additional important jurisdictions around the world as well as corporate initiatives supporting our pre-commercialization efforts,” said Erik Danielson, chief financial officer of the company, which is based in Hasbrouck Heights, New Jersey. “We now plan to significantly step up our communication programs with both the medical as well as the financial communities. Today’s important step forward will be followed up by additional strategic business development activities.”