HASBROUCK HEIGHTS, N.J., Sept. 20, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report that the Independent Data Monitoring Committee for the Company's Phase 2 study of NX-1207 for low risk localized prostate cancer (NX03-0040) has reported a positive interim safety analysis of clinical data from the first group of patients to receive either a high or low dose of NX-1207 for treatment of their localized prostate cancer. The Independent Data Monitoring Committee is an arm's length independent body mandated to conduct periodic interim safety reviews during the study. The Committee has the authority to recommend changes to the study or to halt the study in the event of unacceptable drug toxicity. The Committee's interim safety analysis found no evidence of such toxicity and accordingly the study is continuing.
The NX03-0040 study tests both low and high doses of NX-1207 for their effect on low grade localized prostate cancer. The NX-1207 dose is administered directly into the area of the prostate where the cancer was detected. The procedure is performed by a urologist in an office setting, does not require anaesthesia, sedation, or catheterization, takes only a few minutes and involves minimal discomfort to the patient. Patients in the study are randomly allocated to either low or high dose NX-1207 or to active surveillance (no treatment). Patients undergoing active surveillance in the trial also have the opportunity to receive NX-1207 after their trial active surveillance participation is completed.
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.