Nymox Releases Further Results from Latest U.S. Study of NX-1207 for Benign Prostatic Hyperplasia
New Study Data Shows Less Interruption of Sleep from BPH For Men Given Nymox Drug
HASBROUCK HEIGHTS, NJ (March 11, 2008) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced today that results from the Company’s new multi-center U.S. Phase 2 study showed evidence that the Company’s proprietary drug NX-1207 can markedly reduce the incidence of nighttime urination (nocturia), a particularly bothersome symptom associated with benign prostatic hyperplasia (BPH). After 90 days, subjects treated with a therapeutic dose of NX-1207 had a mean % reduction in nocturia symptom score of 41% versus 4% for subjects treated with finasteride, an approved BPH treatment. This improvement was statistically significant (p<.001).
Having to repeatedly get up in the night to urinate is a common symptom of BPH that can cause chronic sleep loss and, in turn, lead to fatigue, memory deficits, mood changes including depression, and increased risk of long term medical problems. The nocturia symptom score is a component of the standard AUA BPH Symptom Score used to assess the severity of BPH symptoms and to evaluate BPH treatments.
In the study, subjects received a one-time single dose of NX-1207 administered by intraprostatic injection by a urologist in an office setting. The entire procedure lasted on average 5-10 minutes, with the injection taking 1-2 minutes, and did not require anesthesia or catheterization. There were no significant side effects from NX-1207 in the trial.
Overall, subjects in the study’s Intent-to-Treat group who received 2.5 mg of NX-1207 reported a mean improvement in total AUA BPH Symptom Score of 9.71 points after 90 days as compared to the mean improvement of 4.13 points for subjects randomized to finasteride, an approved drug treatment for BPH. This difference was statistically significant (p=0.001). The AUA BPH Symptom Score measures self-assessed severity of BPH symptoms in 7 areas: 1) sensation 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). Published studies of currently approved drugs for BPH show AUA BPH Symptom Score improvement typically in the 3.5 to 5 point range.
The full results from the study will be released at peer-review medical meetings later in 2008.
The Company previously completed three other U.S. trials and 5 follow-up studies for NX-1207. In a Phase 2 double-blind, placebo controlled, randomized multi-center U.S. Study NX02-0014, patients treated with NX-1207 showed after 3 months a statistically significant mean improvement of 9.35 points in BPH Symptom Score values and a statistically significant reduction in mean prostate volume. A recently completed blinded placebo-controlled follow-up study assessed treatment outcomes for 103 subjects from this Phase 2 study 16 to 27 months after a single treatment with NX-1207 or placebo. The study results showed evidence of durable benefit from NX-1207 treatment. At the time of follow-up, 52% of patients treated with NX-1207 were not on BPH medication and had not required surgical intervention for their BPH since their initial treatment with NX-1207; these patients had a mean improvement of 10.2 points in AUA BPH Symptom Score values.
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. 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 cause acute urinary retention requiring immediate medical attention.
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.
Posted: March 2008