IGC Announces Issuance of Second Patent for the Treatment of Alzheimer’s Using THC

Rhea-AI Summary

India Globalization Capital (IGC) announced that the USPTO has granted a second patent (#11,446,276) for treating Alzheimer’s disease with extreme low dose THC. The original application was initiated by the University of South Florida in 2015, and IGC has developed IGC-AD1 based on this research. Early testing indicates IGC-AD1 may alleviate key Alzheimer’s symptoms, prompting a Phase 2 protocol filing with the FDA for further efficacy testing. Currently, no pharmacological treatments for agitation in Alzheimer’s patients exist, presenting a significant market opportunity for IGC.

Positive

• Second patent granted for Alzheimer's treatment, enhancing IGC's intellectual property portfolio.
• IGC-AD1 shows promise in early tests to improve memory and alleviate agitation in Alzheimer’s patients.
• Phase 2 protocol filed with FDA for further clinical testing of IGC-AD1, indicating progress in drug development.

Negative

• No FDA-approved treatments for agitation in Alzheimer’s, highlighting market uncertainty.
• Significant risks associated with drug development and regulatory approval processes.

POTOMAC, Md.--(BUSINESS WIRE)-- India Globalization Capital, Inc. (“IGC” or the “Company”) (NYSE American: IGC) announced today that the United States Patent and Trademark Office (“USPTO”) issued a second patent (#11,446,276) for the treatment of Alzheimer’s disease entitled “Extreme low dose THC as a therapeutic and prophylactic agent for Alzheimer’s disease.”

The original patent application was initiated by the University of South Florida (“USF”) and filed on July 30, 2015. On May 25, 2017, IGC entered into an exclusive license agreement with USF with respect to the patent application and the associated research conducted on Alzheimer’s disease. On January 9, 2020, the patent application was modified by the Company. Separately, on July 22, 2021, IGC announced the grant of the first patent (11,065,225) for some of that research and work. This new patent is for a continuation of that work.

The Company’s subsidiary, IGC Pharma, used some of the research to develop an oral formulation, IGC-AD1. Based on the USF research on Alzheimer’s cell lines, subject to further testing and clinical trials, testing indicates that on a dose dependent manner, the active agents in IGC-AD1 may ameliorate Aß plaque and decrease ptau, a phosphorylated protein responsible for tangles in neurons. Plaques and tangles are key hallmarks of Alzheimer’s disease. Further, testing in an Alzheimer’s mouse model showed that it improved memory as demonstrated in a Morris Water Maze test.

Based on these promising results, we initiated a Phase 1 study on safety and tolerability and in that study discovered that IGC-AD1 at specific dosing regimens had the potential to modify agitation and other neuropsychiatric symptoms in patients with Alzheimer’s dementia. Encouraged by this, our short term focus shifted to further testing IGC-AD1 as a therapeutic for treating neuropsychiatric synmptoms in Alzheimer’s, more specifically agitation. The Company recently filed a Phase 2 protocol with the U.S. Food and Drug Administration (“FDA”) for further clinical testing of the efficacy of IGC-AD1 on agitation in mild to severe Alzheimer’s.

Currently, there are no FDA approved pharmacological treatments for agitation in dementia from Alzheimer’s and about 70% of Alzheimer’s patients suffer from agitation/aggressiveness. The Company is hopeful that, subject to further trials and FDA approval, IGC-AD1 can provide relief for some of the over 55 million Alzheimer’s patients worldwide.

About IGC:

IGC has two segments: Life Sciences and Infrastructure. The Company is based in Maryland, U.S.A.

Forward-looking Statements: This press release contains forward-looking statements. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required; general economic conditions that are less favorable than expected, including as a result of the ongoing COVID-19 pandemic; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC’s SEC filings. IGC incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on June 23, 2022, and Quarterly Report on Form10-Q, filed with SEC on August 5, 2022, 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 release will occur.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220921005448/en/

Claudia Grimaldi (301-983-0998)

Source: India Globalization Capital, Inc.

FAQ

What is the recent patent granted to IGC for?

IGC was granted a second patent for the treatment of Alzheimer's disease using extreme low dose THC.

What is IGC-AD1?

IGC-AD1 is an oral formulation developed by IGC Pharma based on research from the University of South Florida for Alzheimer's treatment.

What clinical trials is IGC currently conducting?

IGC has initiated a Phase 1 study on safety and tolerability of IGC-AD1 and filed a Phase 2 protocol with the FDA for efficacy testing.

How does IGC-AD1 impact Alzheimer's patients?

Early testing suggests IGC-AD1 may reduce Aß plaques, decrease p-tau levels, and alleviate agitation in patients with Alzheimer's dementia.

What challenges does IGC face with its Alzheimer's treatment?

IGC faces regulatory challenges and the need for FDA approval for IGC-AD1, as well as the absence of existing pharmacological treatments for agitation in Alzheimer's.