July 10, 2008
BPH: A Major Challenge for Men’s Healthcare
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) has developed an innovative new treatment for BPH, NX-1207, which has now entered Phase 3, the final stage of drug testing before applying for FDA approval.
Every day across the U.S., millions of men cope with the symptoms of an enlarged prostate (BPH or benign prostatic hyperplasia). The symptoms include problems with urination such as having to urinate more frequently and having to get up repeatedly during the night. The long-term complications of BPH can be serious and may require emergency care, hospitalization, and surgery. BPH is the fourth most commonly diagnosed ailment of men 50 years of age or older. By age 60, more than 50% of men are affected by BPH; by age 85 up to 90%. The burden of BPH is expected to grow as the population ages and more and more men enter their 50s and 60s.
NX-1207 successfully completed Phase 2 trials in the U.S. prior to entering Phase 3. In two multi-center Phase 2 U.S. prospective blinded randomized trials, men treated with NX-1207 had a statistically significant improvement in BPH symptoms 3 months after a single NX-1207 treatment with no reported serious drug-related side effects, including no significant sexual side effects. The aggregated mean improvement in the AUA BPH Symptom Score for the therapeutic dose of NX-1207 (2.5 mg) was 10.3 points or a 44% improvement in Symptom Score. This improvement compares favorably to the 3.5 to 5 point improvement in Symptom Score reported for the currently approved BPH drugs. Unlike NX-1207, these drugs must be taken on an ongoing daily basis and have been associated with bothersome sexual side effects and with problems such as dizziness and weakness.
NX-1207 is injected directly into the prostate in a single procedure performed by a urologist in an office setting. The procedure takes a few minutes, and does not require anesthesia or catheterization.
Results of 6 follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment for over 4 years from the date of single 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 Score reduction, which represents a 47% improvement in symptoms from before treatment.
BPH treatment represents a growing market with more than 100 million men worldwide being estimated to suffer from BPH symptoms. The disorder is a common affliction of older men and is associated with growth in prostate size as men age. BPH causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems, and can cause acute urinary retention requiring immediate medical attention.
More information about Nymox is available at www.nymox.com, email: [email protected], 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. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.