Nymox Announces New Positive Long-Term 39-45 Month Follow-Up Results From NX02-0016 U.S. Study of NX-1207 for BPH
New Study Results Indicate Durable Clinical Response to New
Therapy for Enlarged Prostate Currently in Phase 3
HASBROUCK HEIGHTS, NJ (April 13, 2011) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to report positive new results from the 39-45 month follow-up study of patients treated with NX-1207 in Study NX02-0016. The initial study, completed in the U.S. in 2007, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days and 6 months post-treatment with NX-1207 2.5 mg. The new study assessed American Urological Association BPH Symptom Index scores in blinded subjects without additional NX-1207 treatment after 39-45 months. There were no significant drug safety problems reported by any subjects in the study initially as well as in the new long-term follow-up.
Patients in the new study were followed and have remained blinded as to treatment subsequent to their participation in Nymox’s U.S. Study NX02-0016. The initial study was undertaken in 2007 at 32 U.S. sites and enrolled 85 subjects. The new study includes results from all currently available patients. The new study found that 54% of available patients who received NX-1207 2.5 mg had required no further medical or surgical treatments for their BPH at any time in the long-term follow-up period. Patients who received NX-1207 2.5 mg without any other subsequent treatment for their BPH had a mean improvement at 39-45 months of 11.5 points in their symptom scores. In the control group only one subject had not required
any additional BPH treatments. The NX-1207 2.5 mg cohort’s level of improvement reached statistical significance. 58% of the NX-1207 2.5 mg subjects and controls were available for the follow-up study. Additional data from this new long-term study will be released at a later date.
In the initial study’s Intent-to-Treat cohort after 90 days, the tested therapeutic dose of NX-1207 had a mean BPH Symptom Score improvement of 9.71 points, which was markedly better than the improvement shown by control groups (p<.001). 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 side effects associated with those drugs, which can include sexual problems (such as impotence, loss of libido, and retrograde ejaculation), blood pressure changes and other adverse reactions. Results of follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment for up to 7½ years from the date of treatment.
NX-1207 is a novel patented drug developed by Nymox which is currently in Phase 3 trials. NX-1207 is injected by a urologist in an office setting and involves little or no pain or discomfort. For more information about the NX-1207 Phase 3 clinical trials please go to www.clinicaltrials.gov or contact Nymox at firstname.lastname@example.org.
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.
More information about Nymox is available at www.nymox.com, email: email@example.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.
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Nymox Pharmaceutical Corporation
Posted: April 2011