Nymox Releases Positive New Clinical Trial Data on Durability of Benefits for Early Responders to Company?s BPH Drug NX-1207
HASBROUCK HEIGHTS, NJ (November 23, 2009) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced today the release of positive new clinical trial data from responder analysis of the Company’s pooled multicenter U.S. Phase 2 studies of NX-1207, indicating durable early responder benefits from Nymox’s innovative drug treatment for benign prostatic hyperplasia (BPH). The study concerned patients who reported a 6 point or better improvement in BPH Symptom Score improvement within a month of treatment (early responders). At follow-up (14 months on average post-treatment), proportionally there were over 4.3 times as many NX-1207 early responders who had maintained a 6 point or better improvement in symptom score and who did not require further BPH treatment of any kind as compared to placebo controls.
Results were statistically significant (p<.001) and the data was obtained from all available and eligible patients assessed at up to 19 months post treatment.
The mean improvement in symptom score at 3 months for all patients who received a single 2.5 mg dose of NX-1207 (the dose being used in the ongoing U.S. Phase 3 trials of NX-1207) was 10.5 points; the median improvement was 10 points. This treatment benefit compares favorably to the mean symptom score improvement typically found after 3 months for currently approved BPH medications such as alpha blockers and 5 alpha reductase inhibitors (in the 3 to 5 point range). Patients treated with NX-1207 did not report any of the sexual side effects or the low blood pressure side effects associated with the approved drugs. Unlike currently approved BPH medications, NX-1207 treatment does not require the patient to take pills daily for the rest of his life.
NX-1207 is a novel drug developed by Nymox which is in Phase 3 development for the treatment of BPH. The drug has successfully completed a series of blinded controlled multi-center U.S. clinical trials where it has been found to produce improvements that are about 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.
BPH treatment represents a growing market with more than 100 million men worldwide being estimated to suffer from BPH symptoms. 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 lead to other complications.
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.
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Posted: November 2009