HASBROUCK HEIGHTS, N.J., April 23, 2013 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to announce that the first patient has been enrolled in the Company's Study NX02-0022. The NX02-0022 Study is designed as an open label study of the safety and efficacy of NX-1207 reinjection for the treatment of prostate enlargement (benign prostatic hyperplasia or BPH). The new study will enroll 100-200 subjects who had previously participated in an NX-1207 BPH study and will involve a second treatment of intraprostatic NX-1207 2.5 mg.
The new study will also use a lyophilized formulation of NX-1207 that can be stored at room temperature. The new formulation is also being used in the Company's Phase 2 NX03-0040 prostate cancer study which is in progress.
The use of NX-1207 for the treatment of moderate to severe BPH is being evaluated in five Phase 3 trials. In addition to the large U.S. pivotal Phase 3 studies (studies NX02-0017 and NX02-0018), the new drug is being tested in two Phase 3 multi-center reinjection studies (studies NX02-0020 and NX02-0022) and a multi-center Phase 3 study in Europe (in collaboration with Nymox's European partner, Recordati S.p.A.). Two of these studies (NX02-0017 and NX02-0020) have completed enrollment and a third (NX02-0018) is nearing completion.
NX-1207 is also being evaluated in a U.S. Phase 2 study (NX03-0040) for the treatment of localized low-risk prostate cancer.
NX-1207 is a novel patented drug developed by Nymox. NX-1207 is injected by a urologist under ultrasound guidance directly into the area of the prostate to be treated in an in-clinic procedure that takes only a few minutes and does not require catheterization, anesthetics or sedation. Studies to date have shown that intraprostatic NX-1207 treatment is well-tolerated by patients, does not impair sexual function, and has not shown any drug-related significant side effects.
In completed blinded multi-center U.S. clinical trials of NX-1207 for the treatment of BPH, a single injection 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.
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.
Brian Doyle Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.com