HASBROUCK HEIGHTS, N.J., Nov. 19, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that recruitment will begin for NX02-0022, an open-label study of NX-1207, the Company's Phase 3 drug for benign prostatic hyperplasia (BPH). The study will enroll approximately 100-200 subjects who have already participated in previous studies of NX-1207. The study will assess the safety and efficacy of repeat injection of the drug. Eligible subjects will be enrolled from approximately 70 U.S. clinical trial sites.
The study will run concurrently with the large pivotal Phase 3 studies of NX-1207 which are ongoing. NX02-0022 is expected to be concluded before the pivotal studies are completed. For each enrolled subject in the new trial, participation will last 180 days.
Earlier this year, Nymox completed enrollment of Study NX02-0020, in which 200 subjects who had previously participated in U.S. studies of NX-1207 were given a second injection of NX-1207. There have been no safety problems associated to date with Study NX02-0020. Results from Study NX02-0020 are expected to be announced in the near future.
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. NX-1207 is also in U.S. Phase 2 studies for prostate cancer. 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. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
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