FDA Approves Initiation of IGC’s Cannabinoid Trial on Alzheimer’s Patients
August 11 2020 - 5:03PM
Business Wire
IGC Announces FDA Removal of Clinical Hold
for Multiple Ascending Dose Study of IGC-AD1, Targeting Patients
Suffering from Alzheimer’s-related Dementia
India Globalization Capital (“IGC” or the “Company”) (NYSE
American: IGC) announced today that on July 30, 2020, the U.S. Food
and Drug Administration (FDA) notified IGC that it has authorized
the Company to initiate a Phase 1 human trial study for the
Company’s investigational cannabinoid formulation for the treatment
of patients suffering from mild to severe dementia due to
Alzheimer’s disease. After the completion of administrative tasks,
the Company plans to begin enrolling patients suffering from
Alzheimer’s-related dementia for a 12-subject safety Multiple
Ascending Dose (MAD) Study. The Company believes that the FDA’s
approval of the initiation of the Phase 1 trial is a significant
next step in IGC’s efforts to develop a potential therapy for
treating patients suffering from a devastating disease.
As previously announced, in 2017, the Company acquired exclusive
rights to a patent filing by the University of South Florida (USF)
entitled “THC as a Potential Therapeutic Agent for Alzheimer’s
Disease,” that uses ultra-low doses of cannabinoids combined with
other compounds to create a formulation that is intended to assist
in the treatment of Alzheimer’s disease. The Company subsequently
refiled the patent and filed an additional patent on the
formulation that it intended to use as a treatment for
Alzheimer’s.
In 2018, the Company announced data indicating potential
improvement in memory of transgenic mice suffering from
Alzheimer’s. In 2018, the Company also announced data indicating
the formulation’s potential efficacy on reducing plaques and
tangles in Alzheimer’s cell lines. Plaques and tangles are
hallmarks of Alzheimer’s.
In late 2018, the Company held a pre-Investigational New Drug
Application (INDA) submission meeting with the FDA. In 2019, the
Company received permission from the Institutional Review Board
(IRB) of Puerto Rico to conduct a trial. And, later in 2019, the
Company filed an INDA for a 100-person double blind
placebo-controlled trial on patients suffering from Alzheimer’s
disease.
According to the Alzheimer’s institute about 5.5 million
individuals suffer from Alzheimer’s in the United States and about
44 million suffer from the disease worldwide. Currently, there is
no cure for Alzheimer’s disease.
“Our strategy with IGC-AD1 is to initially conduct trials that
establish the efficacy of IGC-AD1 on the Behavioral and
Psychological Symptoms of Dementia (BPSD). Patients with moderate
Alzheimer’s suffer from BPSD that includes among other symptoms
delusions, agitation, aggression, depression, anxiety, apathy, and
sleep disorder. Eventually, we expect to evaluate the efficacy of
IGC-AD1 on plaques and tangles, the hallmarks of Alzheimer’s
disease. We are excited with the progress made and that the FDA
will allow the Company to initiate trial testing on human subjects
using natural organic cannabis extracts. We believe that this a
first human trail of this sort,” said Ram Mukunda, CEO of IGC.
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 a number
of 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,
worsening of the COVID-19 outbreak in China, the U.S., and other
parts of the world, the prolonged continuation of travel
restrictions related to the outbreak, continued disruption of the
Hong Kong economy, competitive conditions in the industries in
which IGC operates, failure to meet operational goals and/or
revenue and profit targets for products in various stages of
production and commercialization, failure to commercialize one or
more of the products or technologies of IGC, including any products
or patented formulations identified herein, or the failure or
inability to pay patent maintenance fees, unexpected trial results
or trial results that do not support the efficacy of our
formulation, potential rejection of any patent application even
when the Company is in compliance with USPTO requirements, any
changes in federal, state, or local law applicable to our
businesses and the locations where we operate, general economic,
political, and health and welfare conditions that are less
favorable than expected, the FDA’s general position regarding
hemp-based and related products in particular, the FDA’s decision
to deny approval of further trials, or investigative new drug
application, and other factors, many of which are discussed in our
SEC filings. Precautions including social distancing, travel
restrictions, among others, surrounding the Covid-19 pandemic could
lead to delays and a more expensive trial. The Risk Factors
identified in the Company’s annual report, filed on Form 10-K with
the SEC on July 13, 2020, and in the Company’s quarterly reports,
filed on Form 10-Q with the SEC on November 5, 2019 and February
10, 2020, are incorporated herein by reference. In light of these
risks and uncertainties, there can be no assurance that the
forward-looking information contained in this release will in fact
occur.
About IGC: IGC has two lines of business: infrastructure
and life sciences, including hemp-derived medical
cannabis/industrial hemp. The company is based in Maryland, U.S.A.
Our website: www.igcpharma.com, www.igcinc.us. Twitter @IGCIR
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Claudia Grimaldi 301-983-0998
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