HASBROUCK HEIGHTS, N.J., Jan. 28, 2014 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) today provided updates on pivotal Phase 3 development activities for NX-1207, the Company's Phase 3 drug for benign prostatic hyperplasia (BPH), a common affliction of older men. NX-1207 is also in development in Phase 2 for localized prostate cancer. The Company's two large pivotal prospective double blind placebo-controlled U.S. clinical trials (NX02-0017 and NX02-0018) have completed enrollment. One open label safety study (NX02-0020) of subjects who have received a second injection of NX-1207 has completed enrollment and 6 month data has been reported previously. A second open label reinjection study (NX02-0022) is in progress. In Europe, patient recruitment is ongoing at investigational sites in five major European countries in a Phase 3 blinded comparator-controlled clinical trial under the sponsorship of the Company's European licensing partner, Recordati S.p.A.
Patient participation in the NX02-0017 U.S. pivotal Phase 3 BPH study is completed. Patient participation in the second U.S. pivotal trial, NX02-0018, will be completed in Q2 2014. Upon completion of patient participation and blinded data verification and monitoring procedures and auditing activities, unblinding and data analyses of the two pivotal studies will commence at the appropriate time in Q2 2014 with top line results being reported expeditiously when available.
NX-1207 is being evaluated in a large U.S. Phase 2 study of localized low-grade prostate cancer (NX03-0040), involving approximately 150 subjects. Recruitment for the study is now closed and results from the study are expected end of Q1 or early Q2 2014.
BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life and can lead to acute urinary retention, incontinence and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.
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.
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