The independent commission has given a positive recommendation based on evaluation of the data in the company’s current pivotal phase II trial of NX-1207 in benign prostatic hyperplasia (BPH).
The independent data monitoring committee has examined unblinded trial results and reached a favorable conclusion, recommending continuation of the trial.
Dr Paul Averback, CEO of Nymox, said: “We are excited by the overall near-term prospects of NX-1207, and look forward to the trial’s completion. There is considerable and growing interest in Nymox’s new BPH drug.”
NX-1207 has completed two earlier phase I and II trials where the drug produced on average over 23% prostate shrinkage in one month with minimal side effects.
Overall there have been no sexual side effects, and a better side effect profile compared to existing drugs.
The symptomatic improvement in earlier trials reached 10 points on the BPH Symptom Score, which is far superior to available drugs, and compares to invasive and surgical treatments.
According to Nymox, BPH afflicts approximately half of men over the age of 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.