IGC Completes the Final Cohort of Its Phase 1 Clinical Trial on Alzheimer’s Patients
June 23 2021 - 6:50PM
Business Wire
India Globalization Capital, Inc. (“IGC” or the “Company”) (NYSE
American: 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. Daily, we monitored and
recorded certain solicited adverse events, such as somnolence,
falls, dizziness, asthenia, suicidal ideation, hypotension,
hypertension, psychiatric symptoms, seizures, paradoxical nausea
and vomiting. We also monitored unsolicited adverse events such as
urinary tract infections and other abnormalities. All adverse
events were tabulated and measured using a severity scale and
compared against trial halting rules.
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).
About IGC:
India Globalization Capital, Inc. (IGC) engages in the
development of cannabinoid-based therapies for indications such as
Alzheimer's disease and pain. It operates in two lines of business,
Infrastructure and Life Sciences and is headquartered in Potomac,
MD. www.igcinc.us www.igcpharma.com
Forward-Looking Statements:
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,
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 investigational new drug or formulation
described in this release, or failure to obtain FDA approval for
the investigational new drug; testing results from human clinical
trials that may not be favorable or as anticipated; 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 Reports on Form 10-K filed with
the SEC on June 14, 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
release will occur.
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version on businesswire.com: https://www.businesswire.com/news/home/20210623005964/en/
Claudia Grimaldi info@igcinc.us Phone: 301-983-0998
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