- Micro cap Nymox Pharmaceutical (NASDAQ:NYMX +17.2%) moves up on more that a 2.5x surge in volume in response to its announcement of positive long-term results in 344 men with benign prostatic hyperplasia (BPH), or enlarged prostate, who received a single repeat injection of lead product candidate fexapotide after the initial blinded treatment with the drug or placebo in Phase 3 studies.
- Patients were followed for an average of 4.2 years (2.0 - 6.5 years) after initial treatment. There was a statistically significant improvement of 6.5 points in the American Urological Association (AUA) BPH score compared to study participants who received placebo (p<0.001). Repeat injection was found to be safe with no significant drug-related toxicities or side effects reported.
-
Fexapotide (NX-1207) is administered directly into the prostate via a transrectal injection that does not require anesthesia or sedation.
- According to the company, it has completed seven Phase 3 BPH studies in the U.S. It plans to file regulatory applications in the next one or two quarters.