Nymox Pharmaceutical will submit a New Drug Application (NDA) for Fexapotide Triflutate for the treatment of BPH in the US, the company said Monday.
It has recently had a pre-NDA meeting with FDA, it noted and said that the it will submit the NDA later this year.
However, Nymox said it can’t give assurances about the timelines or outcomes of any submission and that no forward looking statements will be made.
It said that the full results of the its Phase 3 US trials were recently published in World Journal of Urology, which is the Official Journal of the Urological Research Society and is also the Official Journal of the International Society of Urology.
The article’s lead author was Dr. Neal Shore, along with 16 co-authors consisting of prominent clinical trial urologist-investigators from across the US. The peer review article is entitled “Fexapotide Triflutate: Results of Long-Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement”.
Summary of reported results of U.S. studies of Fexapotide Triflutate for BPH
Fexapotide Triflutate (NX-1207) is an office-based pro-apoptotic protein injectable for BPH and for low grade localized prostate cancer. The drug mechanism of action is to lead to programmed natural cell death (apoptosis) selectively in prostate glands when injected intraprostatically by the transrectal route. Adjacent tissues and structures (such as nerves, bladder, rectum, urethra and periprostatic tissues) are unaffected by Fexapotide. To date, over 1700 men have been injected by the transrectal route with Fexapotide or placebo in U.S. trials. There have been no significant safety events attributed to the molecule in over a decade of studies.