India Globalization Capital, Inc. IGC shares are advancing strongly after the company unveiled plans to start an early-stage clinical trial for its cannabinoid, or CBD, formulation.
What Happened: Maryland-based Indian Globalization Fund, which operates two business lines, namely infrastructure and life sciences, said late Tuesday the FDA had notified July 30 that it could go ahead with a Phase 1 trial to evaluate its investigational CBD formulation for the treatment of patients suffering from mild-to-severe dementia due to Alzheimer's disease.
The company said it plans to begin enrolling patients for a 12-subject safety Multiple Ascending Dose study.
In 2017, the company acquired rights to a patent filing by the University of South Florida related to a formulation consisting of ultra-low doses of CBDs combined with other compounds that will likely assist in the treatment of Alzheimer's disease.
Following a patent refiling and an additional patent filing, and animal studies, the company held a Pre-IND meeting with the FDA in late 2018. In 2019, the company filed an INDA for a 100-person double blind placebo-controlled trial in Alzheimer's patients.
Why It's Important: Alzheimer's disease doesn't have an approved treatment option currently, although there are therapies for alleviating symptoms of the disease.
About 5.5 million individuals suffer from Alzheimer's in the U.S. and about 44 million suffer from the disease worldwide, Indian Globalization Fund said, citing data from the Alzheimer's institute.
What's Next? The company said it plans to initially conduct trials to establish efficacy of the formulation, codenamed IGC-AD1, on the Behavioral and Psychological Symptoms of Dementia. Eventually, the company plans to evaluate the efficacy of IGC-AD1 on plaques and tangles, characteristics of Alzheimer's.
Shares of India Globalization Fund were spiking higher by 59% to $1.02.
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