Nymox NX-1207 Prostate Cancer Trial Receives Second Positive Interim Safety Review From Independent Data Monitoring Committee
HASBROUCK HEIGHTS, N.J., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) today announced 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 second positive analysis of safety data from the clinical trial. The Independent Data Monitoring Committee assessed patients to date who have received high dose 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 at pre-determined stages 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.
NX-1207 is 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. Phase 3 trial activities of NX-1207 for BPH have recently begun in Europe sponsored by Recordati S.p.A., the company's European licensing partner. In the BPH studies to date, a single dose of NX-1207 has been found to produce symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs.
BPH causes progressive difficulties with urination, such as nocturia, urge to void frequently, acute urinary retention and other problems. The condition can seriously impact the health and quality of life of middle aged and older men. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and a high proportion of men as they age suffer from moderate to severe urinary problems and symptoms associated with BPH.
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. 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: Roy Wolvin
Nymox Pharmaceutical Corporation