Nymox Announces Completion of Patient Enrollment in Final Pivotal U.S. Phase 3 BPH Study
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 7 1/2 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.
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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Nymox Pharmaceutical Corporation
Posted: May 2013