POTOMAC: India Globalization Capital announced that on July 30, 2020, the U.S. Food and Drug Administration (FDA) notified IGC that it has authorized the Company to initiate a Phase 1 human trial study for the Company’s investigational cannabinoid formulation for the treatment of patients suffering from mild to severe dementia due to Alzheimer’s disease.

After the completion of administrative tasks, the Company plans to begin enrolling patients suffering from Alzheimer’s-related dementia for a 12-subject safety Multiple Ascending Dose (MAD) Study. The Company believes that the FDA’s approval of the initiation of the Phase 1 trial is a significant next step in IGC’s efforts to develop a potential therapy for treating patients suffering from a devastating disease.

As previously announced, in 2017, the Company acquired exclusive rights to a patent filing by the University of South Florida (USF) entitled “THC as a Potential Therapeutic Agent for Alzheimer’s Disease,” that uses ultra-low doses of cannabinoids combined with other compounds to create a formulation that is intended to assist in the treatment of Alzheimer’s disease. The Company subsequently refiled the patent and filed an additional patent on the formulation that it intended to use as a treatment for Alzheimer’s.

In 2018, the Company announced data indicating potential improvement in memory of transgenic mice suffering from Alzheimer’s. In 2018, the Company also announced data indicating the formulation’s potential efficacy on reducing plaques and tangles in Alzheimer’s cell lines. Plaques and tangles are hallmarks of Alzheimer’s.

In late 2018, the Company held a pre-Investigational New Drug Application (INDA) submission meeting with the FDA. In 2019, the Company received permission from the Institutional Review Board (IRB) of Puerto Rico to conduct a trial. And, later in 2019, the Company filed an INDA for a 100-person double blind placebo-controlled trial on patients suffering from Alzheimer’s disease.

According to the Alzheimer’s institute about 5.5 million individuals suffer from Alzheimer’s in the United States and about 44 million suffer from the disease worldwide. Currently, there is no cure for Alzheimer’s disease.

“Our strategy with IGC-AD1 is to initially conduct trials that establish the efficacy of IGC-AD1 on the Behavioral and Psychological Symptoms of Dementia (BPSD). Patients with moderate Alzheimer’s suffer from BPSD that includes among other symptoms delusions, agitation, aggression, depression, anxiety, apathy, and sleep disorder. Eventually, we expect to evaluate the efficacy of IGC-AD1 on plaques and tangles, the hallmarks of Alzheimer’s disease. We are excited with the progress made and that the FDA will allow the Company to initiate trial testing on human subjects using natural organic cannabis extracts. We believe that this a first human trail of this sort,” said Ram Mukunda, CEO of IGC.