HASBROUCK HEIGHTS, N.J., April 21, 2009 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that NX02-0017, the first Phase 3 U.S. clinical trial for NX-1207, the Company's investigational drug for BPH, has been given Investigational Review Board approval to begin. Screening and enrollment of patients will formally begin in the next 2 weeks. The Company will undertake 2 pivotal Phase 3 U.S. clinical trials for NX-1207, with a total of 1000 patients. The protocol and patient materials have been officially approved by the Investigational Review Board. Currently there are agreements with 60 investigational sites in the U.S. The Company expects the number of clinical trial sites to be increased to up to 100 investigational sites. The most experienced BPH clinical research centers and many of the largest urology practices in the U.S. will be participating.
The Phase 3 trials for NX-1207 will test the safety and efficacy of the drug treatment of BPH as compared to placebo. Efficacy will be determined by symptomatic improvement, using the American Urological Association BPH Symptom Index, which measures the severity of the irritative and obstructive urinary symptoms of BPH, including frequency, urgency, intermittency, hesitancy, sensation of incomplete voiding, weak stream, and nocturia. The trials will also investigate the drug's effect on prostate volume, urinary maximum flow rate, and several other pertinent measurements.
Blinded clinical trials to date have shown that men treated with NX-1207 reported statistically significant improvement in BPH symptoms 3 months after a single NX-1207 treatment with no reported serious drug-related side effects, including no (0%) significant sexual side effects. In two multi-center Phase 2 U.S. prospective randomized blinded clinical trials, the aggregated mean improvement in the BPH Symptom Score for 2.5 mg NX-1207 was 10.3 points or a 44% improvement in Symptom Index.
Currently approved drugs for BPH provide on average 3 to 5 points improvement, and must be taken daily for the rest of the patient's life. Currently approved drugs have many side effects such as impotence, loss of libido, retrograde ejaculation, dizziness, and weakness.
Results of 7 follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment for up to 5 years from the date of treatment. The Company recently announced statistically significant improvement compared to placebo in a 22 to 33 month follow-up study of 93 patients treated with NX-1207 at 17 U.S. clinical trial sites. Results in that study showed that patients at follow-up without any other treatment for BPH had a mean of 11.3 points BPH Symptom Index reduction, which represents a 47% improvement in symptoms from before treatment.
BPH is one of the most commonly diagnosed diseases in the male U.S. population. The condition can seriously impact the health and quality of life of men 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.
More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.
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.