New longer term follow-up results from Nymox' phase I-II testing of NX-1207, the company's investigational new drug for benign prostatic hyperplasia, have shown statistically significant improvement and no safety issues, encouraging the market to boost company shares up by 11%.
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The trial data indicated that at 18-23 months’ follow-up, there was symptomatic improvement and no safety problems in individuals treated with NX-1207. The symptomatic improvement was determined to be statistical significance.
“These are exciting results,” said Dr Paul Averback, CEO of Nymox, “NX-1207 now has shown statistical significance in clinical improvement measures at up to 23 months. The potential for long term improvement in benign prostatic hyperplasia (BPH) from NX-1207 now has phase II data to support it.”
Dr Averback added, “We will be providing further clinical details on these findings at a later date. We are also anticipating other new trial data later in 2005 from the large currently ongoing multicenter trial of NX-1207.”
Patients in the trial of NX-1207 who were available for follow-up were administered AUA Symptom Score evaluations after periods of 18-23 months post treatment. The mean AUA score in patients treated with NX-1207 showed a 9.3 point improvement compared to controls. This reached statistical significance and exceeded results from the phase I-2 30 day study of NX-1207 reported by Nymox earlier in 2004.
In the latter study there was a 6.9 point improvement in AUA score. Subjects followed up after one year also showed a statistically significant improvement of 8.8 points compared to controls.
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.