HASBROUCK HEIGHTS, N.J., July 15, 2014 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today the closing of enrollment for Study NX02-0022, the Company's second re-injection Phase 3 clinical trial of the safety and efficacy of NX-1207 for the treatment of enlarged prostate (benign prostatic hyperplasia or BPH). The NX02-0022 study enrolled patients who had previously participated in an earlier NX-1207 BPH study, and in the new trial these men received a second open-label injection of NX-1207. The study used a new lyophilized formulation of NX-1207 that has longer stability stored at room temperature.
An interim analysis of the new efficacy data from the NX02-0022 study will be reported within the next few weeks.
In the first reported NX-1207 reinjection NX02-0020 study, mean overall symptomatic improvement in the AUA BPH Symptom Score in treated patients was 7.6 points (p<.001). Each patient had received either one or two injections of NX-1207 with the mean duration from the initial injection to the final assessment of 26 months.
NX-1207 is currently being assessed in 5 Phase 3 and one Phase 2 clinical trials. Data verification and auditing procedures are in progress for the Company's U.S. clinical trials NX02-0017 and NX02-0018 which have completed enrollment and patient participation. Unblinding and top line analysis of efficacy and safety data will be conducted and reported once these procedures have been concluded. In Europe, patient recruitment is ongoing at investigational sites in European countries in a large pivotal Phase 3 blinded comparator controlled clinical trial under the sponsorship of the Company's European licensing partner, Recordati S.p.A.
BPH is one of the most commonly diagnosed diseases of middle aged and elderly men. The condition can have a significant negative impact on a man's health and quality of life and can lead to urinary retention, incontinence and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and over 25% of men over the age of 40 suffer from moderate to severe urinary symptoms and associated problems 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.
CONTACT: Brian Doyle Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.comSource:Nymox Pharmaceutical Corporation