HASBROUCK HEIGHTS, N.J., June 11, 2014 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to announce new clinical data supporting the positive safety profile of NX-1207, the Company's lead compound in late Phase 3 testing for prostate enlargement (BPH or benign prostate hyperplasia). Recent pharmacokinetic studies using a newly developed highly sensitive blood test for NX-1207 have shown that the drug is undetectable in the blood post-injection, providing strong evidence that the drug, once injected into the prostate, remains confined to the prostate and thus unable to affect other organs such as the liver, kidneys, heart, or testes. These results are consistent with the pharmacological profile of the drug and with the extensive body of safety data from the more than 1,000 men treated with the drug to date demonstrating the absence of any significant drug-related side effects.
In addition, men treated with NX-1207 have not displayed any signs of an allergic or other immune reaction to the drug either on first injection or repeat injection. Extensive clinical immunogenicity testing of men in the Company's pivotal Phase 3 trials (NX02-0017 and NX02-0018) and Phase 3 repeat injection safety studies (NX02-0020 and NX02-0022) have found no evidence of anti-drug antibody formation after exposure to the drug. The Company will present more detailed scientific data from these studies at upcoming medical conferences.
Currently approved drugs for BPH can produce significant sexual side effects such as impotence, decreased libido, ejaculation disorders, and male breast enlargement. In the clinical trials to date, NX-1207 has not shown to produce these sexual effects. Some approved BPH drugs, including combination drug therapies, are also associated with an increased risk of high-grade prostate cancer. By contrast, the area of the prostate targeted with NX-1207 treatment showed less prostate cancer progression with less radiation and surgery due to cancer progression as compared to controls in the recent NX03-0040 Phase 2 localized prostate cancer trial.
Nymox recently announced the completion of its second pivotal Phase 3 trial of NX-1207 for BPH, NX02-0018, and top-line results for its Phase 2 trial of NX-1207 for localized low risk prostate cancer, NX03-0040.
NX-1207 is a novel patented drug developed by Nymox that 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 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.
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: [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. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
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