Nymox Pharmaceutical reports positive data from Phase II BPH studies
NYMX | Quote | Chart | News | PowerRating -- Nymox Pharmaceutical has reported new positive clinical trial data from responder analysis of the company's pooled multi-center US Phase II studies of NX-1207, indicating durable early responder benefits from the company's drug treatment for benign prostatic hyperplasia or BPH.
The study concerned patients who reported a six point or better improvement in BPH symptom score improvement within a month of treatment.
At follow-up (14 months on average post-treatment), proportionally there were over 4.3 times as many NX-1207 early responders who had maintained a six point or better improvement in symptom score and who did not require further BPH treatment of any kind as compared to placebo controls.
Results were statistically significant (p less than 0.001) and the data was obtained from all available and eligible patients assessed at up to 19 months post-treatment.
The mean improvement in symptom score at three months for all patients who received a single 2.5mg dose of NX-1207 (the dose being used in the ongoing US Phase III trials of NX-1207) was 10.5 points; the median improvement was 10 points. 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 and five alpha reductase inhibitors (in the three to five point range).
Patients treated with NX-1207 did not report any of the sexual side effects or the low blood pressure side effects associated with the approved drugs. Unlike currently approved BPH medications, NX-1207 treatment does not require the patient to take pills daily for the rest of his life, said Nymox.
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