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news.Nymox Pharmaceutical, a biopharmaceutical company, has announced the Nexus-1 and Nexus-2 Phase III clinical trials for NX-1207, the company's new drug for benign prostatic hyperplasia.
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The Nexus-1 and Nexus-2 trials are the company’s pivotal Phase III North American clinical studies for NX-1207. It is anticipated that the trials will enroll over 800 subjects and involve 50-100 investigational sites. Currently the company is in the process of site recruitment at over 60 locations throughout the US.
In blinded US Phase II clinical trials to date, NX-1207 has proven to be both safe and efficacious in the treatment of BPH, a common affliction of older men. A single administration of NX-1207 2.5mg produced on average improvements in the standardized BPH symptom score that were approximately double that reported for currently approved BPH drugs.
Men treated with NX-1207 reported an improvement in their BPH symptoms one or two weeks after a single NX-1207 treatment. After three months, the average improvement in BPH symptom score was 10.3 points (44% improvement from baseline). This improvement was statistically significant as compared to controls, the company said.