POTOMAC, Maryland – (COMMERCIAL THREAD) – India Globalization Capital, Inc. (“IGC”) (NYSE American: IGC) today announced that it has completed Cohort 2 of its Phase 1 clinical trial of IGC’s new investigational drug based on tetrahydrocannabinol (“THC”), IGC-AD1, for relieving symptoms in people with Alzheimer’s disease. As previously reported, IGC has submitted IGC-AD1 to the United States Food and Drug Administration (“FDA”) under Section 505 (i) of the Federal Food, Drug and Cosmetic Act. IGC received approval to proceed with the trial from the FDA on July 30, 2020.
As previously announced, for Cohort 1, we administered one dose of the new investigational drug IGC-AD1 per day to trial participants. We increased the dosage to two doses of IGC-AD1 per day in cohort 2, which ran from early February 2021 to mid-May 2021. The Data and Safety Monitoring Committee (“DSMC”) for the IGC clinical trial, after reviewing the data obtained by cohort 1 and cohort 2, recommended switching to cohort 3, which consists of administering three doses per day. Participants are monitored daily for safety and certain behavioral changes using, among others, the Neuropsychiatric Inventory Scale (NPI) and the Columbia-Suicide Severity Rating Scale (C-SSRS). The Phase 1 clinical trial in patients with Alzheimer’s disease is currently scheduled to end between July and September 2021.
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, in patients with the disease. ‘Alzheimer’s. IGC is pleased to move to Cohort 3 of its Phase 1 clinical trial in participants with Alzheimer’s disease to continue testing the safety of IGC-AD1 at higher doses.
According to the World Health Organization, Alzheimer’s disease is expected to affect approximately 50 million people worldwide by 2030. IGC-AD1 is intended to help relieve symptoms in people living with Alzheimer’s disease , who may experience restlessness, restlessness, anxiety, irritability, listlessness, disinhibition, delusions, hallucinations, and changes in sleep or appetite, among other symptoms. As the disease progresses, individuals can experience memory loss and dementia. This Phase 1 trial is currently testing IGC-AD1 for safety. Based on the results of this first phase of clinical trials and pending appropriate FDA approvals, IGC intends to continue further efficacy trials at a later date.
A Phase 1 clinical trial is the first step in a human clinical trial in a multi-step process designed to gain regulatory approval for the commercialization of a new pharmaceutical drug. This multi-step process for obtaining FDA approval is described in IGC’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (“SEC”) on July 13, 2020.
About the IGC:
India Globalization Capital, Inc. (IGC) is dedicated to the development of cannabinoid-based therapies for indications such as Alzheimer’s disease, Parkinson’s disease and pain. It operates in two lines of business, infrastructure and life sciences, and is headquartered in Potomac, Maryland.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, some of which are beyond the control of ‘IGC. Actual results could differ materially from these forward-looking statements due, among other factors, to the failure or inability of the Company to commercialize one or more of its products or technologies, including the new drug or the new formulation of research described in this release, or failure to obtain FDA approval for the new investigational drug; human clinical trial test results which may not be favorable or as expected; less favorable general economic conditions than expected, in particular due to the ongoing COVID-19 pandemic; the general position of the FDA on cannabis and hemp products; and other factors, many of which are discussed in documents filed by IGC with the SEC. IGC incorporates by reference the human trial disclosures and risk factors identified in its annual reports on Form 10-K filed with the SEC on July 13, 2020 and June 14, 2019 and its quarterly reports on Form 10-Q filed with the SEC. of the SEC on August 19, 2020, November 20, 2020 and February 12, 2021, as if fully incorporated and restated herein. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this press release will materialize.