IntelGenx Receives Health Canada Authorization to Proceed with New Amendment for Montelukast VersaFilm® Phase 2a Trial
- Ongoing BUENA Trial to Continue at Increased Daily Dose -
SAINT LAURENT, Quebec, Jan. 15, 2020 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that Health Canada has issued a No Objection Letter in response to IntelGenx’s amended Clinical Trial Application (“CTA”) for the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”).
“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.”
IntelGenx’s amended CTA was based on additional efficacy testing of Montelukast in an AD mouse model, conducted in collaboration with Prof. Dr. Ludwig Aigner’s group at the Paracelsus Medical University in Salzburg. As reported in the manuscript entitled, Montelukast dose-dependently improves cognitive outcome in the 5xFAD mouse model of Alzheimer’s Disease1, overall results demonstrated that the treatment effect was dose-dependent, with higher doses of Montelukast significantly increasing the mice’s cognition in two behavioural tests. These results are supported by a case report2 confirming that Montelukast, when given at higher doses, significantly improves cognition in patients suffering from memory impairment and dementia.
1 Michael J. Rabl R., Poupardin R. , Tevini J., Felder T., Paiement N., Zerbe H., Hutter-Paier B. , Aigner L.
2 Rozin, S.I., Case Series Using Montelukast in Patients with Memory Loss and Dementia. Open Neurol J, 2017. 11: p. 7-10.
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer significant benefits to patients and physicians for many therapeutic conditions.
IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
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Source: IntelGenx Technologies Corp.
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Andre Godin, CPA, CA
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