India Globalization Capital, Inc. (NYSEAMERICAN:IGC) is the biggest gainers in the pre-market session on Wednesday after the company issued Alzheimer’s drug trial update.
Major Trigger:
IGC Completes the Final Cohort of Its Phase 1 Clinical Trial on Alzheimer’s Patients
Key Highlights:
- IGC announces today it has completed Cohort 3 of its Phase 1 clinical trial on IGC’s tetrahydrocannabinol (“THC”)-based investigational new drug, IGC-AD1, intended to alleviate the symptoms of individuals suffering from Alzheimer’s disease. As previously disclosed, IGC submitted IGC-AD1, its investigational drug candidate for Alzheimer’s, to the U.S. Food and Drug Administration (“FDA”) under Section 505(i) of the Federal Food, Drug, and Cosmetic Act.
- IGC received approval to proceed with the Phase 1 trial, on Alzheimer’s patients, from the FDA on July 30, 2020. Cohort 3 is the final cohort in IGC’s Alzheimer’s Phase 1 trial. The Data and Safety Monitoring Committee (“DSMC”) for IGC’s clinical trial will review the data from Cohort 3, and IGC will report its findings from all three Cohorts to the FDA.
- As previously announced, for Cohort 1, we administered one dose of the investigational new drug IGC-AD1 per day to Alzheimer’s patients, which we increased to two doses in Cohort 2 for the same Alzheimer’s patients, and to three doses in Cohort 3. This Phase 1 trial focuses on the safety and tolerability of IGC-AD1 on patients suffering from mild to severe Alzheimer’s.
- To IGC’s knowledge, this is the first human clinical trial using low doses of natural THC, a psychoactive member of the cannabinoid class of natural products produced by the Cannabis sativa plant, on Alzheimer’s patients. We are motivated by the potential that, with future successful results from appropriate further trials, IGC-AD1 could contribute to relief for some of the 50 million people around the world expected to be impacted by Alzheimer’s disease by 2030 (WHO, 2020).
Market Reaction
As of 8:40, IGC is soared 33% to $1.97. So far more than 1.04 million shares have exchanged hands.
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