October 8, 2008
Nymox Updates NX-1207 Product Development Activities
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) provided today an update on development activities for the Company's NX-1207 drug for the treatment of benign prostatic hyperplasia (BPH) or enlarged prostate, a common affliction of older men. The drug has the potential to have major impact on current management of BPH.
Presentations of clinical study data at annual regional meetings of urologists in the U.S. in the last month were well-received and further presentations are scheduled in the coming month. There is significant interest from many major pharmaceutical companies to license and market NX-1207 and the Company is carefully reviewing its options for future marketing arrangements for the drug. NX-1207 has entered its Phase 3 development program, the last stage before filing with the FDA for approval for commercial distribution and sale. The Company has received a large number of communications from patients and doctors throughout the U.S. and internationally, interested in participating in clinical trials and wanting to learn more about the drug. Investigative site recruitment activities are proceeding well.Brian Doyle, Director of Nymox Business Development, said "It is particularly encouraging to see the response to the NX-1207 studies from urologists and patients. It speaks to the tremendous need for a simple and effective treatment for BPH".
There is an increased awareness of the need for an effective treatment for BPH. In August 2008, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) released its Prostate Research Strategic Plan calling for further research into BPH. The report noted that BPH is one of the most commonly diagnosed diseases in the male U.S. population with a large portion of any primary care physician's or urologist's practice consisting of BPH management. The condition affects men of all races and ethnic groups and can progress in severity over time. If left untreated, BPH can lead to significant consequences, such as acute urinary retention, incontinence, and urinary tract infection. The report 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.
NX-1207 involves a new targeted approach to the treatment of BPH. The drug is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs and the injection takes only a few minutes and involves little or no pain or discomfort. In multicenter U.S. clinical trials to date NX-1207 has been found to produce improvements in BPH symptom score that are approximately double that reported for currently approved BPH drugs without the sexual and blood pressure and other side effects that are associated with those drugs.
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. 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.