IGC Completes its Phase 1 Clinical Trial on Alzheimer’s Patients, Reports Safety and Tolerability
September 07 2021 - 7:30PM
Business Wire
(NYSE American: IGC), India Globalization Capital, Inc. (“IGC”,
or the “Company”), today announces the completion of its Phase 1
clinical trial on IGC’s cannabis-based investigational new drug,
IGC-AD1, for patients suffering from Alzheimer’s disease. As
previously disclosed, IGC submitted IGC-AD1 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 from the FDA on July 30, 2020.
The primary end point of this Phase 1 trial was safety and
tolerability. Based on this study, and subject to FDA concurrence,
generally, the cannabis-based investigational drug IGC-AD1 was safe
and well-tolerated by the Alzheimer’s trial participants. The
safety and tolerability data has been filed with the FDA in IGC’s
Annual Report.
The trial was conducted on 12 participants suffering from
Alzheimer’s disease. The participants represent a frail geriatric
population with multiple comorbidities and mild to moderate
Alzheimer’s disease. Each participant had a caregiver that helped
manage the daily reporting. For this Phase 1 trial, the average age
of participants was 80.9 years, with an average weight of 141.2
pounds with 66.7% being women and 33.3% being men.
The trial’s secondary end points, including pharmacokinetics,
genotyping, neuropsychiatric inventory, and measurement of suicide
severity have also been completed. We expect to report this data as
it becomes available and after submission to the FDA. At this
stage, there can be no assurance as to the results that this
secondary data will show or that it will meet any of our
expectations.
To IGC’s knowledge, this is the first human clinical trial using
low doses of natural Tetrahydrocannabinol (“THC”) in combination
with another molecule, on Alzheimer’s patients. THC is a
psychoactive member of the cannabinoid class of natural products
produced by the Cannabis sativa plant. IGC hopes that, with future
successful results from appropriate further trials subject to FDA
approval, 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, Twitter @IGCIR.
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 or additional clinical trials; 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, and Quarterly Report
on Form 10-Q, filed with the SEC on August 11, 2020 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/20210907005938/en/
Claudia Grimaldi info@igcinc.us/Phone: 301-983-0998
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