HASBROUCK HEIGHTS, N.J., April 20, 2015 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today long-term clinical trial results from the Company's NX-1207 Phase 2 prostate cancer study NX03-0040. The new results demonstrate statistically significant (p=.0067) better outcomes at up to 2.8 years for NX-1207 treated patients compared to controls. Trial participants included 146 patients with low grade localized prostate cancer at 44 U.S. investigational sites.
A controlled comparison was conducted of patients who required and received radiation and surgery treatments for their cancer based on blinded post-treatment upgraded evaluations of their pre-treatment initially positive lower grade cancers. The study found that after up to 2.8 years for NX-1207 single-injection treated patients there was a 68.2% reduction compared to controls in the proportion of patients who had upgraded blinded biopsy results in the treated area and went on to require and receive radiation therapy and/or prostatectomy (surgery) (p=.0067). The new study also found that all instances of surgery or radiation, including elective cases without upgrades, were decreased by 62.7% (p=.0035) in NX-1207 patients compared to the randomized control group.
Long-term clinical outcome is a highly important measure of drug treatment efficacy. Patients were randomized to one of two doses of NX-1207 (2.5 mg or 15 mg) or to active surveillance (control). The drug was injected into the area of the prostate where the cancer was detected and repeat biopsies, serial PSA measurements and long-term follow-up were performed on all patients treated and controls.
Paul Averback MD, CEO of Nymox said "These new results show the potential of NX-1207 to offer men with the most common form of low-grade prostate cancer a significant tangible benefit in terms of avoidance of radiation and/or surgery and the related risks, discomforts, and permanent side effects. The results show a significant positive effect from a single painless injection which is very exciting."
To date, NX-1207 has had an excellent safety profile. NX-1207 has shown safety in 9 clinical trials (BPH and prostate cancer) including repeat injection studies. The drug does not lead to immune responses such as antibody formation which can cause significant drug toxicity and/or limit usage to single treatments due to drug neutralizing effects.
One of the major problems with current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, or brachytherapy) is the relatively high incidence of reported sexual dysfunction post-treatment. In 9 studies, NX-1207 treatment has been shown to have no significant adverse effect post-treatment on sexual function or testosterone levels.
Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of newly diagnosed prostate cancers are initially considered low risk.
For more information please contact info@nymox.com or 800-936-9669.
This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Development of drug products involves substantial risks and actual results may differ materially from expectations. Factors that could cause actual results or events to differ materially from those projected in forward-looking statements are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.