Nymox Reports Significant Long-Term Improvement in BPH Symptoms After NX-1207 Treatment in New Multi-Center U.S. Study
HASBROUCK HEIGHTS, NJ (May 28, 2008) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) today announced significant long-term improvement in symptoms of benign prostatic hyperplasia (BPH) in men treated with the Company’s investigational drug NX-1207 in a newly completed clinical study.
The controlled study assessed BPH symptoms and treatment outcomes 22 to 33 months after a single treatment with NX-1207 or placebo in 93 consecutive unselected patients at 17 clinical trial sites across the U.S. The follow-up study was designed to assess the durability of the beneficial treatment effect of NX-1207 which is a key factor for patients and urologists and for payor acceptance of the drug. The study measured how much of the symptomatic improvement persisted in men who were initially responders to the drug in the trial.
Compared to baseline, individuals on no other treatment for BPH who received NX-1207 22-33 months previously showed statistically significant improvement at 3 therapeutic dose levels of NX-1207: 10 mg (p=.019), 5 mg (p=.0029), and 2.5 mg (p=.0068). Control patients who had received placebo showed no statistically significant difference from baseline. Low dose NX-1207 (.125 mg) has been shown in a separate blinded clinical trial not to have statistically significant effect on BPH symptoms.
Results in the new study also showed that patients at follow-up without any other treatment for BPH had a mean of 11.3 points BPH Symptom Score reduction, which represents a 47% improvement in symptoms from before treatment. These responders at 22 to 33 months follow-up maintained an average 92% of their initial 90 day improvement after a single NX-1207 treatment.
Paul Averback MD, CEO of Nymox said, “The results of this controlled clinical study indicate significant improvement in symptoms for BPH patients 2½ years after being given a single treatment of NX-1207, further confirming results from previously completed trials. Based on feedback from urologists and from patients with BPH, we believe that a single 5 minute procedure will be highly preferable for the majority of men, especially when compared to the alternatives with their unwanted side effects”.
Currently approved drugs for BPH result in a 3.5 to 5 point improvement in AUA BPH Symptom Score, and must be taken on an ongoing daily basis. These approved drugs have the drawbacks of bothersome sexual side effects and other associated problems such as dizziness and weakness. There have been no significant sexual side effects from NX-1207.
In the initial trial, patients given NX-1207 had a 9.35 point mean BPH Symptom Score improvement at 90 days, which was significantly better than placebo (p=.017). The improvement in NX-1207 treated patients at follow-up has now been demonstrated also to be statistically significant.
The Company previously completed four U.S. trials for NX-1207, including the Phase 2 double-blind, placebo controlled, randomized multi-site 2006 U.S. study. A recent Phase 2 study completed in 2008 showed 9.7 points improvement in patients given NX-1207. Individuals treated with NX-1207 have also shown an overall statistically significant reduction in mean prostate volume. Patients treated with NX-1207 have had no serious side effects.
The AUA Symptom Score is a standardized measurement of BPH symptoms and includes data on 1) sensations of incomplete emptying of the bladder; 2) need to urinate frequently; 3) stopping and starting during urination; 4) urgent need to urinate; 5) weakness of urinary stream; 6) need to push or strain during urination; and 7) urination during sleep (nocturia).
BPH afflicts approximately half of men over age 50 and close to 90% of men by age 80. The disorder causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems.
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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Nymox Pharmaceutical Corporation
Posted: May 2008