The therapy’s developer, Nymox Pharmaceutical, had previously reported that Fexapotide caused no sexual or other side effects, but improved sexual function is a new and important finding. The previous side-effects finding was based on 15 years of clinical trials involving men with benign prostatic hyperplasia (BPH).
In the four Phase 3 trials, patients filled out a sexual function questionnaire before receiving Fexapotide, within 12 months of treatment, and some time after 12 months.
Two of the four trials — NX02-0017 (NCT00918983) and NX02-0018 (NCT00945490) — dealt with an initial single injection of Fexapotide. The other two — NX02-0020 (NCT01438775) and NX02-002 (NCT01846793) — dealt with a second injection.
Men who received the initial injection had a statistically significant improvement in sexual function at 12 months, compared with those who received a placebo. The results held true when the treated and placebo groups were assessed after 12 months, even when the evaluations occurred as late as 51 months after treatment.
In fact, those treated with a placebo actually ended up with worse sexual function over the long term.
Another important finding was that Fexpotide even helped men who had experienced sexual dysfunction before treatment. The percentage of patients who said they were no longer having dysfunction after treatment was statistically significant, researchers said. In contrast, men experiencing sexual dysfunction before receiving a placebo continued to have problems.
“The findings newly reported today add another important dimension to the advantages of Fexapotide treatment for BPH,” Dr. Paul Averback, the CEO of Nymox, said in a press release. “In addition to absence of sexual side effects, there is now statistically significant prospective clinical trial evidence of sexual functional improvement in men with prostate enlargement given Fexapotide.”
Nymox will present the findings at coming medical meetings.
Last month, the company announced that it has submitted a marketing approval application to European regulators for the use of Fexapotide Triflutate as a BPH treatment.
Urologists can administer Fexapotide triflutate in their office. It requires no anesthesia or catheterization, and causes little pain or discomfort.
In clinical trials, the drug improved BPH symptoms, reduced the need for enlarged-prostate surgery, and cut the risk of men developing prostate cancer. The trials also showed it to be safe, with no sexual side effects, in comparison with other therapies.