IGC Expanding Clinical Trials Of THC Based Drug Following Approval From Health Canada

India Globalization Capital, Inc. IGC has received a no objection letter from Health Canada for approval of its trial, “A phase 2, multi-center, double-blind, randomized, placebo-controlled trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease.” The no objection letter provides the acknowledgement of IGC-AD1’s drug candidacy and the authority to proceed with phase 2 trials in Canada.

Ram Mukunda, CEO of IGC, stated, “We are pleased to have received this no objection letter from Health Canada, which allows us to begin phase 2 trials on our drug formulation IGC-AD1 at sites throughout Canada. We already have one testing site signed up in Canada, bringing our total number of sites to three, and we are currently in negotiations for several more sites in Florida, Maryland and Montreal. This will also allow us to recruit a diverse population that reflects the demographics of the disease. Receiving this approval is a milestone in our progress towards gaining FDA approval and increases the number of patients with Alzheimer’s that we can enroll. We now have access to several additional locations, including the USA, for our team to safely and efficiently test the efficacy of IGC-AD1 for the treatment of agitation in dementia due to Alzheimer’s disease.”

IGC-AD1 relies on low doses of THC, a psychoactive cannabinoid, and another compound as active agents in trials for Alzheimer’s. The formulation recently commenced phase 2 of clinical trials required by the FDA and demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating a key protein that is responsible for Aβ plaques – a key hallmark of the disease.

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