India Globalization Capital (IGC) Completes Cohort 1 of its Phase 1 THC-Based Clinical Trial on Alzheimer’s Patients
May 14 2021 - 6:01AM
Business Wire
India Globalization Capital, Inc. (“IGC” or the “Company”) (NYSE
American: IGC) announces today that it has completed Cohort 1 of
its Phase 1 clinical trial testing the IGC’s tetrahydrocannabinol
(“THC”)-based formulation, IGC-AD1, intended to alleviate the
symptoms of participants suffering from Alzheimer’s disease. As
previously disclosed, IGC’s Investigational New Drug, IGC-AD1, a
THC-based formulation, was submitted 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
trial from the FDA on July 30, 2020.
As part of the clinical trial process, an independent Data and
Safety Monitoring Committee (“DSMC”) monitors patient safety data
and other factors. A DSMC consists of industry experts with no
affiliation to the trial sponsor, which in this case is IGC Pharma,
LLC, a subsidiary of IGC. The DSMC typically recommends that a
trial continue or terminate based on the committee’s evaluation of
trial safety data. The DSMC for IGC’s trial, having reviewed Cohort
1 data on Alzheimer’s participants, has recommended progressing to
Cohort 2.
IGC’s Phase 1 study is a placebo-controlled Multiple Ascending
Dose (MAD) study on individuals suffering from Alzheimer’s disease.
This study is also evaluating the pharmacokinetics and genotyping
of CYP2C9 polymorphisms to determine impact on THC metabolism. For
example, the study includes evaluating whether individuals with a
particular polymorphism of the CYP2C9 gene impacts the metabolism
of THC, as compared to other individuals. The Company hopes that
this data on pharmacogenetics can eventually inform IGC on
effective dosing for patients with a specific CYP2C9 polymorphism,
and better predict outcomes such as the impact of its THC-based
investigational new drug IGC-AD1 or its interactions with other
medications.
For Cohort 1, we administered one dose of IGC-AD1 per day. In
Cohort 2, we plan to escalate to two doses per day. Alzheimer’s
participants are monitored daily for safety, and for certain
behavioral changes using, among others, the Neuropsychiatric
Inventory (NPI) scale. The Phase 1 trial is currently anticipated
to conclude during the second quarter of the Company’s fiscal year
(July through September 2021).
According to the Alzheimer’s Association, Alzheimer’s disease
impacts about 44 million individuals worldwide. To IGC’s knowledge,
this is the first human 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. IGC
is encouraged by the progress of the Phase 1 trial on participants
suffering from Alzheimer’s disease as it moves into Cohort 2 to
continue testing the safety of IGC-AD1.
A Phase 1 trial is the first step of a human trial in a
multi-step process designed to obtain regulatory approval for the
marketing 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 U.S. Securities and Exchange Commission (“SEC”)
on June 14, 2020.
About IGC:
India Globalization Capital, Inc. (IGC) engages in 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, 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 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
July 13, 2020 and June 14, 2019 and its Quarterly Reports on Form
10-Q filed with 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 release will
occur.
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version on businesswire.com: https://www.businesswire.com/news/home/20210514005124/en/
Claudia Grimaldi info@igcinc.us Phone: 301-983-0998
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