Nymox Pharmaceutical Corporation announced new, prospective and randomized results from Phase 3 clinical trial with its lead drug candidate NX-1207 (fexapotide triflutate) for the treatment of benign prostate enlargement (BPH). Findings confirming that patients given fexapotide as an initial BPH treatment had high efficacy in as early as 10 days, compared with patients on placebo or those who had undergone previous treatments.
These trial results, which also included long-term results, indicate that fexapotide is effective as a first-line BPH treatment, Nymox said in a press release.
Fexapotide is administered by a urologist in an office procedure that is quick, requires no anesthesia or catheterization, and involves little or no pain or discomfort.
The findings are from an analysis of trials NCT00945490 and NCT01438775, and possibly NCT01846793 and NCT01846793, although the status of the last two trials it is not clear from their clinical trials.gov websites. Nymox reports on its website that, while the U.S. Phase 3 trials 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.
The company cites Phase 2 clinical trial data showing men treated with fexapotide had statistically significant improvement in BPH symptoms three and six months following a single fexapotide treatment, with no reported serious side effects, including sexual impairment. Patients also reported an improvement in symptoms as early as a week or two after treatment.
Follow-up findings, undertaken from 2009–16 in available trial participants, provided evidence that durable therapy benefits from fexapotide therapy can persist for as long as six years after a single treatment, the company said.
“It is important to have now demonstrated for Nymox’s fexapotide, both 1. that it leads to an early onset of clinically noticeable improvement; and 2. that it works well long-term as a first-line therapeutic for men who have not tried other treatments before,” Dr. Paul Averback, CEO of Nymox, said in the release. “There is a major unmet need for a convenient, safe and efficacious treatment for countless men worldwide with BPH who are unhappy with their symptoms and who may be unhappy with their available choices.”
Specifically, according to the release, the new Phase 3 data from 390 treatment-naive BPH patients show:
• improvements superior to previously treated BPH patients were reported as early as 10 days post-treatment
• improvements held in these patients at one-month, three-month, six-month, one-year, and long-term (3.5 years) follow-up
• levels of mean change, from pre-treatment baseline, ranged from a 6.49- to a 8.88-point improvement in the self-reported AUA (American Urological Association) BPH Symptom Score
• improvements seen were statistically significant, after a single treatment, compared to placebo patients
The company points out that BPH medications usually also have to be taken on a permanent basis to remain effective, and surgical interventions can lead to problems with ejaculation and general sexual function. Nymox’s fexapotide, for this reason, shows promise as a safer and effective therapy for BPH.
For more information, visit www.nymox.com
Nymox Pharmaceutical Corporation