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HASBROUCK HEIGHTS, N.J., May 3, 2013 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today completion of patient enrollment in the Company's final pivotal U.S. Phase 3 NX02-0018 Study of NX-1207 for BPH. This study is now closed to further enrollment. Top-line results from the large Phase 3 Study are expected in early 2014.
Paul Averback MD, CEO of Nymox said, "Our drug development programs for NX-1207 include 6 large important studies in the U.S. and Europe, and other clinical and non-clinical research activities. Final completion of enrollment in this last major pivotal U.S. study is an important milestone in the NX-1207 development pathway. We look forward to reporting further news."
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. The drug has successfully completed a series of blinded controlled multi-center U.S. clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs. Follow-up studies have shown evidence of long lasting benefit with a significant proportion of men who received a single dose reporting maintained improvement in BPH symptoms without other treatments for up to 7½ years. NX-1207 is injected by a urologist in an office setting and involves little or no pain or discomfort. Phase 3 trial activities of NX-1207 for BPH have begun in Europe sponsored by Recordati S.p.A., the company's European licensing partner.
NX-1207 is also being evaluated for the treatment of low risk localized prostate cancer where NX-1207 is administered directly into the area of the prostate where the cancer was detected. A U.S. Phase 2 study (NX03-0040) for that indication is in progress.