Seven months ago, May 10, DMX announces Phase I/II Penecure clinical trial go ahead.
The new antifungal protocol was developed in consultation with regulatory officials at the U.S. Food and Drug Administration. Mimi Brennan, Dimethaid’s director of regulatory affairs said the 7-month, double-blinded, Phase I/II trial will focus on dose-ranging and safety, although investigators will follow patients long enough to allow picking up initial efficacy trends.
I am wondering why clinical is seven months duration? I know competitor products are 7 months treatment. Wouldn't Penecure have a quicker effect with its more effective transport?
Perhaps the seven months includes, enrollment qualification, treatment period, feed back sessions, follow up. Then the analysis is probably another period of time. Just looking for clarity.
Penecure’s first clinical trial will enrol approximately 90 patients at four Ontario sites. Candidates, between the ages of 18 and 85, must have a clinical diagnosis of distal subungual onychomycosis in at least one greater toenail and be in otherwise good health. Penecure has already passed a proof-of-concept study conducted at the University of California, as well as laboratory dose-ranging and accelerated stability studies. The treatment uses the same technology that underlies Pennsaid®, the country’s first prescription anti-arthritic lotion. |
