Nymox Announces Positive Results in New 2 Year Blinded, Placebo Controlled Study of NX-1207 for Benign Prostatic Hyperplasia
The study assessed symptom scores and treatment outcome 2 years (range 16-27 months) after a single treatment with NX-1207 or placebo. At the time of follow-up, 52% of patients treated with NX-1207 were not on BPH medication and had not required surgical intervention for their BPH since their initial treatment with NX-1207; these patients had a mean improvement of 10.2 points in AUA BPH Symptom Score values, the widely accepted scale used to assess the efficacy of BPH treatments. Currently approved drugs for BPH result in a 3.5 to 5 point improvement in AUA BPH Symptom Score, and must be taken on an ongoing daily basis.
For patients with prostate size <70 grams, the results showed that a statistically significant percentage of patients initially treated once with NX-1207 were not on BPH medication and had not required surgical intervention as compared to patients who received placebo. In this important population, (which corresponds to the group for comparison with other drugs), the results showed that 60% of patients who received NX-1207 required no other BPH treatment, and had maintained an improvement of 11.3 points in BPH Symptom Score (p<.05 versus placebo).
There have been no significant sexual side effects from NX-1207.
Paul Averback MD, CEO of Nymox said, "This blinded clinical study demonstrates a striking degree of long-term improvement in BPH patients given a single treatment of NX-1207, and further confirms the promising results from the earlier completed U.S. clinical trials. The durability of BPH symptom improvement from NX-1207 treatment is of special interest to potential marketing partners for NX-1207."
The Company previously completed three U.S. trials for NX-1207, including a Phase 2 double-blind, placebo controlled, randomized multi-site U.S. study, which showed positive efficacy and safety results for NX-1207 after 3 months in patients with BPH. Overall, patients treated with NX-1207 showed after 3 months a mean improvement of 9.35 points in AUA Symptom Score values, the standard scale used to evaluate BPH drugs and treatments. This improvement compares favorably to the 3.5 to 5 points reported in published studies of currently approved drugs for BPH and reached statistical significance when compared to placebo. Subjects treated with NX-1207 also showed an overall significant reduction in mean prostate volume. The results of the trial demonstrated the excellent safety and side effect profile of NX-1207. Subjects treated with NX-1207 had no serious side effects. In particular, patients given NX-1207 had no (0%) significant sexual side effects.
The AUA Symptom Score is a standardized measurement of BPH symptoms and includes data on 1) sensations of incomplete emptying of the bladder; 2) need to urinate frequently; 3) stopping and starting during urination; 4) urgent need to urinate; 5) weakness of urinary stream; 6) need to push or strain during urination; and 7) urination during sleep (nocturia). Published studies of currently approved drugs for BPH show AUA Symptom Score improvement in the 3.5 to 5 point range.
BPH afflicts approximately half of men over age 50 and close to 90% of men by age 80. The disorder causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems.
More information about Nymox is available at www.nymox.com, email: email@example.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. 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.
Nymox Pharmaceutical Corporation
Roy Wolvin, 1-800-93NYMOX
Posted: November 2007