HASBROUCK HEIGHTS, N.J., Sept. 26, 2013 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that enrollment in the company's NX03-0040 US Phase 2 clinical trial of NX-1207 for localized prostate cancer is nearing completion with over 80% patients now enrolled. Based on current screening and enrollment rates, the company anticipates that enrollment will be completed in the near future. Initial top line study results are expected to be available approximately 2 months after completion of enrollment.
The NX03-0040 study involves 150 patients with low grade localized prostate cancer who are randomized to low or high dose NX-1207 or to control (active surveillance with no drug or surgical or radiation treatment). Patients undergoing active surveillance in the trial also have the opportunity to receive NX-1207 after completion of their active surveillance portion of the trial.
The NX03-0040 study assesses the safety and efficacy of NX-1207 in eradicating or shrinking low grade localized prostate cancer tumors by multiple clinical and laboratory measurements and blinded prostate biopsies at 6 weeks after treatment. Initial top-line results from trial NX03-0040 will be available soon after completion of the post-treatment biopsy assessment of the last patient randomized to drug.
Safety assessments of patients treated to date have been positive with no serious or unexpected adverse effects related to the drug, based on ongoing monitoring and safety committee reviews.
In the study, NX-1207 is administered directly into the area of the prostate where the cancer was detected. The drug treatment is performed by a urologist in an office setting, and does not require anaesthesia, sedation, or catheterization. Treatment takes only a few minutes and involves minimal discomfort to the patient.
About 1 in 6 men will be diagnosed with prostate cancer during their lifetime. Most cases of prostate cancer are detected via prostate-specific antigen (PSA) screening and are usually found as localized tumors. Surgical removal of the prostate (radical prostatectomy) and radiation therapy with or without androgen deprivation therapy are the most common active treatment options for localized prostate cancer but have significant short- and long- term adverse effects, including impotence, urinary dysfunction, and other complications.
NX-1207 is also in Phase 3 clinical trials in the U.S. and Europe for the treatment of benign prostatic hyperplasia (BPH), one of the most commonly diagnosed conditions in older men.
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. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
CONTACT: Brian Doyle Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.comSource:Nymox Pharmaceutical Corporation