HASBROUCK HEIGHTS, N.J., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) today announced that recruitment is being closed for the Company's Phase 2 study of NX-1207 for low risk localized prostate cancer (NX03-0040) and that enrollment will be formally completed shortly. Initial top line study results are expected to be available approximately 6-8 weeks after completion of enrollment.
The NX03-0040 study involves approximately 150 patients with low grade localized prostate cancer who are randomized to low or high single 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 a single injection 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.
The American Cancer Society estimates that in 2012 more than 240,000 men in the United States will be newly diagnosed with prostate cancer and more than 28,000 men will die from the disease. Most cases are detected via prostate-specific antigen (PSA) screening and usually found to have 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 late stage Phase 3 development in the U.S. for the treatment of benign prostatic hyperplasia (BPH), a common condition of older men associated with growth in prostate size as men age. NX-1207 is in Phase development in Europe sponsored by Recordati S.p.A., the company's European licensing partner for the NX-1207 BPH indication.
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: For Further Information Contact: Brian Doyle Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.comSource:Nymox Pharmaceutical Corporation