IGC Announces IRB Approval of its IGC-AD1 for a Phase-2 study
September 19 2019 - 7:00AM
Business Wire
India Globalization Capital, Inc. (NYSE: IGC) announced today
that the Institutional Review Board (“IRB”), in Puerto Rico,
approved its protocol for a double-blind, placebo-controlled,
efficacy, safety and tolerability study of its proprietary
formulation IGC-AD1 on behavior and functionality in subjects with
dementia from Alzheimer’s disease.
“With this important approval, our Company can implement a
50-person double-blind placebo-controlled trial that we hope begins
to prove the efficacy of micro-doses of cannabis in combination
with other natural compounds on the behavior of patients suffering
from Alzheimer’s. We expect to measure improvements in
neuropsychiatric symptoms (“NPI”) such as delusions,
agitation/aggression, dysphoria, anxiety, sleep disorder,
disinhibition, irritability, apathy and eating abnormalities, among
others,” stated Ram Mukunda, CEO.
In 2017, IGC acquired a patent filing from the University of
South Florida (USF) that showed that micro-doses of cannabis in
combination with other natural compounds are beneficial to
Alzheimer’s cell lines and to memory in transgenic mice. Our
product Hyalolex™, modeled after IGC-AD1 and currently available in
more than 40 dispensaries in Puerto Rico is based on this
research.
Regarding the IRB approval for a Phase-2 study, Mr. Mukunda
added, “Our Company will now prepare and file an Investigational
New Drug Application (”INDA”) with the FDA in support of the
protocol. Given that there is no cure or effective treatment for
Alzheimer’s we are hopeful that the FDA will grant the INDA, but
there can be no guarantee”. The University of Puerto Rico Medical
Sciences Campus maintains IRB panels that is responsible for
approving research protocols on human subjects.
About IGC
IGC has two lines of business: i) infrastructure and ii) plant
and cannabinoid-based products. The company is based in Maryland,
U.S.A. Our websites: 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 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, competitive
conditions in the industries in which IGC operates, the results and
implementation of the Phase-2 study, failure to commercialize one
or more of the technologies of IGC, general economic conditions
that are less favorable than expected, the Federal Food and Drug
Administration’s (FDA) general position regarding cannabis-based
products and our products in particular, and other factors, many of
which are discussed in our SEC filings. In light of these risks and
uncertainties, there can be no assurance that the forward-looking
information contained in this press release will in fact occur.
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Claudia Grimaldi (301) 983-0998
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