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Nymox Announces Positive Results From Completed Phase 2 BPH Drug Trial

Posted on: Tuesday, 19 September 2006, 09:01 CDT

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) today announced positive efficacy and safety results from its recently completed Phase 2 trial of NX-1207 for benign prostatic hyperplasia (BPH). 43 clinical trial sites across the U.S. and 175 subjects participated in the double-blind, placebo controlled trial.

Overall, patients treated with NX-1207 showed a total pooled mean improvement of 9.35 points in the primary outcome endpoint of AUA Symptom Score values, which reached statistical significance when compared with the placebo control (p=.017). The mean improvements in AUA Symptom Score for each of the 3 doses used in the trial ranged from 8.10 to 11.03 points with statistical significance measures of p=.015 to 0.17.

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.

The treated subjects also showed an overall significant reduction in mean prostate volume (secondary outcome) of 11.7% (6.84 grams; p=.02).

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. Serious adverse events occurred in 5.1% of all placebo patients, and in 0% of the NX-1207 treated group.

Further details on the trial results will be presented at a later date.

Paul Averback MD, CEO of Nymox said, "Nymox is carefully moving this drug ahead as rapidly as possible. This placebo-controlled blinded 43 site U.S. clinical trial demonstrates a striking degree of improvement in BPH patients given NX-1207, and confirms the promising results from the earlier Phase 1 and Phase 2 completed studies."

Dr. Averback added, "In relation to the performance of this new drug, we have certainly seen enthusiasm from investigators and participants in the clinical study."

The double-blind, placebo-controlled, randomized, parallel group, 3 dose range study was designed to test safety and efficacy after 3 months in patients with BPH. Patients were enrolled who had AUA Symptom Score values of, greater than or equal to 15 points and prostate volumes of, greater than or equal to 40 grams. The study was conducted across 43 centers in the U.S. 175 subjects were enrolled in the trial. Patients were assessed by medical and symptom evaluation, prostate volume studies, uroflow measurements, laboratory and safety parameters at baseline and repeatedly over the course of 3 months. Outcome variables were based on analysis after 3 months.

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: 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.

Source: Business Wire

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