Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced successful new trial data from the long-term recurrent injection group from the Phase III study for fexapotide. It is the firm’s lead compound in late phase advancement for enlarged prostate and for localized prostate cancer.
The objective of the trial was to decide the clinical benefit and safety fexapotide can offer to men who were administered a second injection of fexapotide for BPH. In the latest trial long-term results were decided in 344 subjects who were offered a single repeat fexapotide regimen after preliminary blinded treatment with placebo or fexapotide.
Subjects were followed for an average 4.2 years after preliminary treatment. All regimen failures were covered in the assessment. Data have now proven that there had been long-term statistically considerable symptomatic improvement compared to Phase III subjects who obtained placebo alone. Repeat injection was established to be safe with no considerable drug related side effects or toxicities found in the trial.
The experts speak
Dr. Paul Averback MD, who is the CEO of Nymox said that this trial data in reinjected patients show that fexapotide results in clinically important long-term symptomatic enhancements in BPH subjects. This is achieved with minimal treatment, and in absence of the bothersome and worrisome toxicities of conservative BPH regimens such as increased cancer risk and retrograde ejaculation.
The earlier announced Phase III trials have proven that fexapotide minimizes the long-term requirement for surgery by nearly 82-95% as against approved conservative BPH regimen. Data suggests that fexapotide shows considerable effectiveness against prostate cancer when used as a therapeutic. In addition, it has shown to mitigate the prostate cancer risk when fexapotide is utilized to cure BPH. This is against some conventional BPH regimen in routine clinical application which on contrary intensifies prostate cancer risk.
Nymox’s lead candidate fexapotide has been in advancement for more than a decade. It has been assessed by expert clinical study investigative teams in more than 70 eminent clinical trial centers in the U.S. The company expects to release further results and analyses when available in the imminent future. It will issue the data of the fexapotide clinical studies in peer review medical journals and in presentations at urological and medical meetings.
