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For Immediate Release: Nymox Releases Positive New Clinical Trial Data on Response Rates to Company’s Prostate Drug NX-1207
HASBROUCK HEIGHTS, NJ (April 1, 2008) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced today the release of positive new clinical trial data from the Company’s latest multi-center U.S. Phase 2 study of NX-1207, Nymox’s innovative drug treatment for benign prostatic hyperplasia (BPH). In the study’s Intent-to-Treat group at 3 months, more than four times as many positive responses to treatment were documented in subjects randomized to the NX-1207 therapeutic dose as compared to subjects randomized to the comparator finasteride (finasteride is an approved drug for BPH). For the purposes of the comparison, positive response was defined as a 10 point BPH Symptom Score improvement, which in the study corresponded to a 45% average decline in the severity of BPH symptoms. This difference in response rate between NX-1207 and the comparator was statistically significant (p<.001). In the study, mean improvement in the NX-1207 Intent-to-Treat group was 9.71 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 (in the 5 point range) and 5 alpha reductase inhibitors (in the 3 point range). Patients treated with NX-1207 did not report any of the sexual side effects associated with the use of 5 alpha reductase inhibitors and alpha blockers, nor any of the low blood pressure side effects associated with alpha blockers. The Company reported data that showed that 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 41% mean reduction in nocturia symptom score 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. In the NX-1207 studies, 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 have been no significant side effects from NX-1207 in the trials to date.
Overall, subjects in the most recent 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 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. More information about Nym, email: 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.
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