Health Canada has issued a No Objection Letter in response to IntelGenx’s amended application for its ongoing trial in patients with mild to moderate Alzheimer’s Disease.
IntelGenx (TSXV:IGX,OTCQX:IGXT) announced that Health Canada has issued a No Objection Letter in response to IntelGenx’s amended Clinical Trial Application for its ongoing Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.
As quoted in the press release:
“We are delighted with Health Canada providing the authorization for IntelGenx to proceed with our amended protocol, which enables us to continue the BUENA trial at an increased daily dose,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “We are looking forward to continuing enrollment at our Canadian sites under this amended protocol, which is based on preclinical data demonstrating Montelukast VersaFilm’s increased efficacy at higher doses. In addition, we continue to evaluate the trial’s expansion to the United States via a potential Investigational New Drug Application filing with the U.S. Food and Drug Administration.”