Nymox Pharmaceutical Corporation (NASDAQ: NYMX) this week announced positive study data for its compound called fexapotide, which is being developed to treat prostate enlargement (BPH). But what next after the long-term study outcome?
Seeking marketing approval?
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) plans to seek regulatory approval to market fexapotide as a treatment for prostate cancer. According to CEO, Paul Averback, they have always had plans to apply for regulatory clearance to bring fexapotide to market. The latest long-term study findings appear to bring the company closer to its goal of marketing fexapotide.
When it comes to asking regulator to approve fexapotide for commercialization, Nymox wanted to have solid data to back its application for approval. Specifically, the company said it would use long-term data on safety and efficacy profile of fexapotide to convince regulators that it has a promising drug to combat prostate cancer. Therefore, Nymox believes that the latest data on the study of fexapotide strengthens the case for its regulatory clearance to enter the market. If successful, fexapotide should help improve the quality of life for middle-aged and elderly men afflicted by prostate cancer.
No timetable for approval filing
Although Nymox Pharmaceutical Corporation (NASDAQ: NYMX) now has strong evidence to face regulators with the request for fexapotide approval, the CEO didn’t disclose when they hope to make such application.
The outcome of the study by Nymox Pharmaceutical Corporation (NASDAQ: NYMX)
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) studied fexapotide treatment in 995 male subjects in the U.S. over a period of seven years. Analysis of the patients enrolled showed a remarkable reduction in prostate cancer incidence among the men who received the treatment for the study duration. Fexapotide was compared to a placebo in the study.
Not only did Nymox observe that fexapotide performed better than a placebo in lowering the risk of prostate cancer, but also noted that the level of the disease incidence was significantly lower than normal occurrence.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX)’s fexapotide is currently in Phase 3 study for BPH, but the company has continued to carry more tests on the drug with hopes of expanding its label.