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Nymox Pharmaceutical (NYMX) Announces Completion Of Second Pivotal Phase 3 NX-1207 Trial For BPH


5/8/2014 9:11:35 AM

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HASBROUCK HEIGHTS, N.J., May 8, 2014 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that the last enrolled patient has completed participation in the Company's pivotal Phase 3 clinical trial, NX02-0018. The NX02-0018 trial is the second of two pivotal prospective double blind placebo-controlled U.S. clinical trials being conducted to evaluate NX-1207 2.5 mg for the treatment of benign prostatic hyperplasia (BPH), a common affliction of older men. The first pivotal Phase 3 trial of NX-1207 for BPH, NX02-0017, has already completed patient participation. Both trials will be unblinded once data verification and auditing activities have been completed.

NX-1207 is a novel patented drug developed by Nymox for the treatment of BPH and localized prostate cancer. The drug is administered by a urologist in an office setting directly into the zone of the prostate to be treated. The procedure takes only a few minutes, does not require sedation, anesthesia or catheterization, and involves little or no pain or discomfort.

NX-1207 had previously successfully completed a series of blinded controlled multi-center U.S. clinical trials for BPH where a single 2.5 mg dose of NX-1207 was found to produce at 90 days an average improvement in standardized symptom score about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs. Follow-up studies showed evidence of long lasting benefit with a significant proportion of men who received a single dose reporting maintained improvement in BPH symptoms without other treatments for up to 5 years or more.

The Company recently announced top line results of its two dose (2.5 mg or 15 mg) blinded prospective controlled Phase 2 study of NX-1207 for the treatment of localized low-risk prostate cancer, NX03-0040. Results indicated an overall benefit in terms of reduced cancer progression in patients treated with a single injection of NX-1207 into the area of the prostate where cancer was found as compared to active surveillance (no treatment) controls. Follow-up analysis after up to 22 months found that for patients with upgraded biopsies in the treated area, those treated with NX-1207 required 85% less radiation and surgery treatments compared to controls. Consistent with earlier clinical trial experience with NX-1207, there were no significant safety issues or side effects associated with either the high dose (15 mg) or low dose (2.5 mg) of the drug in this study.

BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life 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.

CONTACT: For Further Information Contact:
Brian Doyle
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com

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