Nymox's NX-1207 For The Treatment Of Benign Prostatic Hyperplasia In Phase 3 Program

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 24 Sep 2008 - 7:00 PDT

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Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to announce that results from the most recently completed clinical studies of NX-1207, the Company's investigational drug for the treatment of benign prostatic hyperplasia (BPH), will be presented on Thursday, September 25 at the 82nd Annual Meeting of the North Central Section of the American Urological Association being held in Chicago. Neil D. Shore, MD, FACS, of Myrtle Beach, SC will make the podium presentation.

NX-1207 has entered Phase 3 development, having successfully completed a series of multi-center U.S. clinical trials where it has been found to produce improvements that are approximately double that reported for currently approved BPH drugs. NX-1207 is administered by a urologist in an office procedure that takes only a few minutes and involves little or no pain or discomfort. Patients notice improvement as early as a week or two after treatment. Follow-up studies have shown that many men showed continued benefit from a single NX-1207 treatment for 2 years or more. NX-1207 treatment does not require the patient to take pills daily for the rest of his life, like currently approved BPH medications.

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 Primary Endpoint of BPH Symptom Score for 2.5 mg NX-1207 was 10.3 points or a 44% improvement in Symptom Score.

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 up to 4½ 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 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, affecting approximately half of men over age 50 and close to 90% of men by age 80, 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 http://www.nymox.com.

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