Nymox releases positive trial data of prostatic drug

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). 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. For the purposes of the comparison, positive response was defined as a 10 point benign prostatic hyperplasia (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). 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. This treatment benefit compares favorably to the mean symptom score improvement typically found after three 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 data also showed that NX-1207 can markedly reduce the incidence of nighttime urination (nocturia), a particularly bothersome symptom associated with 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. This improvement was statistically significant (p<.001).