HASBROUCK HEIGHTS, N.J., Nov. 11, 2013 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) reported a favorable update and recent Safety Monitoring Committee review of safety data for the Company's NX02-0022 reinjection study for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The most recent Safety Monitoring Committee meeting found no significant safety concerns to date. Enrollment in this study at participating investigational sites across the U.S. has passed the 50% accrual level.
Trial NX02-0022 is an open label study of the safety and efficacy of NX-1207 reinjection for the treatment of BPH. The study is open to subjects who had previously participated in an NX-1207 BPH study. All patients are given an intraprostatic injection of NX-1207 2.5 mg. The first of two NX-1207 reinjection studies (NX02-0020) was successfully completed in January 2013. Patients with BPH in the earlier NX02-0020 reinjection study received one or two injections of NX-1207 into the prostate. Mean overall improvement in the 192 treated men was 7.6 points in their AUA BPH Symptom Scores (p < .001). The mean duration from the initial injection to the final assessment was 26 months.
Ongoing testing of NX-1207 has not shown any evidence of the drug eliciting an immune reaction in men treated with intraprostatic injections of NX-1207. Extensive clinical immunogenicity testing of men in the Company's pivotal Phase 3 trials (NX02-0017 and NX02-0018) and Phase 3 repeat injection safety studies including the current Study NX02-0022 and the earlier Study NX02-0020 have shown no evidence of antidrug antibody formation. Safety monitoring reviews of the NX-1207 trials to date have shown no evidence of any allergic reaction to the drug either on first injection or repeat injection.
NX-1207 for the treatment of BPH is in Phase 3 development in the U.S. In the EU a multi-center pivotal Phase 3 study is being conducted under the sponsorship of the Company's European licensing partner, Recordati S.p.A. Enrollment has been completed for the two large U.S. pivotal Phase 3 studies (NX02-0017 and NX02-0018) and the first U.S. reinjection study (NX02-0020) has been successfully completed.
NX-1207 is also being evaluated in a U.S. Phase 2 study (NX03-0040) for the treatment of localized low-risk prostate cancer.This study is nearing completion.
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, anesthesia 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. Previous clinical trials found that a single administration of NX-1207 2.5 mg produced on average improvements in the standardized BPH symptom score (8-10 points at 90 days) that were approximately double that reported for currently approved BPH drugs (3-5 points). Follow-up studies have shown durable clinically significant benefit for up to 7 ½ years after a single treatment.
BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life and can lead to acute urinary retention, incontinence and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years 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.
For Further Information Contact: Brian Doyle Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.com