Update On IGC’s Phase 1 Clinical Trial on Alzheimer’s Patients
February 22 2021 - 8:00AM
Business Wire
India Globalization Capital, Inc. (“IGC” or the “Company”) (NYSE
American: IGC) is pleased to announce the progress of its
tetrahydrocannabinol (THC)-based phase 1 clinical trial, which was
approved to proceed by the U.S. Food and Drug Administration
(“FDA”) on July 30, 2020, as previously disclosed.
On February 11, 2021, the Company completed administering the
first of three levels of dosing of IGC-AD1, the Company’s
cannabinoid-based investigational new drug, on the first five of
twelve patients suffering from Alzheimer’s disease. The Company
continues to enroll the remaining patients.
Enrolling patients and commencing the trial involves obtaining
Informed Consent, conducting neurological exams, and conducting
initial blood tests, among others, to identify inclusion and
exclusion criteria to ensure that patients meet the enrollment
requirements.
Once enrolled, patients undergo additional blood draws to assess
variations of the gene CYP2C9. Follow-up blood draws continue
thereafter at specific time intervals to assess the amount of
formulation in the patient’s system and the amount of time it takes
patients to metabolize the active ingredients (pharmacokinetics) in
IGC-AD1.
Through this data, we hope to map variations of CYP2C9 to the
metabolization of the active ingredients in IGC-AD1, including THC
(pharmacogenetics). For example, we hope to learn how fast, or how
slow, an elderly patient with Alzheimer’s and a specific variation
of CYP2C9 metabolizes THC, the psychoactive component of cannabis.
This is an important insight into drug interaction, as the gene
CYP2C9 makes an enzyme that metabolizes THC as well as about 100
medications, including a broad spectrum of medicines prescribed for
pain, cholesterol, and seizures, among others.
“While it has taken a long time to get to this trial, with many
hurdles crossed along the way, including restrictions due to the
Covid-19 pandemic, we are excited to have begun administering
IGC-AD1, which uses a plant-derived cannabinoid, in an active
trial. While others have focused on CBD (cannabidiol), the
non-psychoactive component of cannabis, our trial is focused on
THC, the psychoactive component. There is no known cure for
Alzheimer’s disease, but we believe that THC, in combination with
other drugs, may help with the management of Alzheimer’s patients,
improve patient lifestyle, and bring a certain degree of relief for
their caregivers,” said Ram Mukunda, CEO of IGC.
A Phase 1 trial is the first 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 detail in the Company’s annual report
on Form 10-K for the Fiscal Year 2019, filed with the U.S.
Securities and Exchange Commission (“SEC”) on June 14, 2019. Our
Phase 1 study is a placebo-controlled study. IGC-AD1 will be
administered for three 14-day periods, called cohorts, with the
dose-escalated as low, medium, and high for each cohort. The
participants are monitored daily, and data is collected to
determine safety based on solicited and unsolicited adverse events.
We are also monitoring changes in certain behavioral aspects of
patients to better inform on designs for the anticipated next phase
of trials that will test efficacy on specific symptoms. The Phase 1
trial is conducted and managed by IGC’s subsidiary, IGC Pharma
LLC.
The trial is listed on
https://www.clinicaltrials.gov/ct2/show/NCT04749563?term=IGC+Pharma&draw=2&rank=1
About IGC:
IGC operates two lines of business: (i) infrastructure and (ii)
life sciences. The Company is based in Potomac, Maryland, U.S.A.
social media: 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; 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 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/20210222005481/en/
Claudia Grimaldi info@igcinc.us / Phone: 301-983-0998
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