Nymox Pharmaceutical has received the investigational review board’s approval to begin NX02-0017, the first Phase III US clinical trial for NX-1207, the company’s investigational drug for benign prostatic hyperplasia. Screening and enrollment of patients will formally begin in the next two weeks.
The company will undertake two pivotal Phase III US clinical trials for NX-1207, with a total of 1,000 patients. The protocol and patient materials have been officially approved by the investigational review board. Currently there are agreements with 60 investigational sites in the US. The company expects the number of clinical trial sites to be increased to up to 100 investigational sites.
The Phase III trials for NX-1207 will test the safety and efficacy of the drug treatment of benign prostatic hyperplasia (BPH) as compared to placebo. Efficacy will be determined by symptomatic improvement, using the American Urological Association BPH Symptom Index, which measures the severity of the irritative and obstructive urinary symptoms of BPH, including frequency, urgency, intermittency, hesitancy, sensation of incomplete voiding, weak stream, and nocturia.
The trials will also investigate the drug’s effect on prostate volume, urinary maximum flow rate, and several other pertinent measurements, the company added.