Guardion Health Sciences Initiates Placebo-Controlled Clinical Trial Involving Proprietary GlaucoCetin® Product
May 03 2021 - 08:10AM
Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the
“Company”), a clinical nutrition and diagnostics company that
develops clinically supported nutrition, medical foods, supplements
and medical devices, announced the initiation of a
placebo-controlled clinical trial to study the impact on visual
function, as measured by visual field sensitivity, in patients with
glaucoma after a 12-week regimen of GlaucoCetin®.
GlaucoCetin is the Company’s proprietary medical
food designed to provide support for mitochondrial activity in
optic nerve cells. Mitochondrial dysfunction and loss of activity
is now thought to be a key factor for vision loss from glaucoma, as
well as other common debilitating eye diseases.
The 12-week double-blind study will evaluate 100
patients randomized to receive either GlaucoCetin or a placebo at a
1:1 ratio. Patients will be recruited based on two additional
subgroups: those with central vision loss and those with peripheral
vision loss. In addition to the primary endpoint of visual field
testing, secondary end points include evaluating changes in quality
of life, electrophysiology, contrast sensitivity and blood levels
of antioxidants, particularly glutathione. Contrast sensitivity is
being evaluated using proprietary testing technology from
VectorVision, a wholly owned subsidiary of the Company.
“This study, which we are proud to have
initiated with one of the leading university-based eye research
centers on the East Coast, supports our overall strategy of
evaluating the efficacy of our medical foods through rigorously
designed clinical studies that demonstrate patient benefits in the
real-world,” commented David Evans, Ph.D., Guardion’s Chief Science
Officer.
About Guardion Health
Sciences
Guardion Health Sciences, Inc. (Nasdaq: GHSI),
is a clinical nutrition and diagnostics company. Guardion offers a
portfolio of science-based, clinically supported nutritional
supplements, medical foods, and diagnostic products that support
healthcare professionals, their patients, and consumers in
achieving health goals. Guardion’s commercial and developmental
initiatives are supported by equally impressive scientific and
medical advisory boards, led by seasoned business executives and
physicians with many years of experience. This combination of
expertise and scientific knowledge forms the foundation of
Guardion’s growing position within the eye care industry and the
clinical nutrition marketplace. Information and risk factors with
respect to Guardion and its business, including its ability to
successfully develop and commercialize its proprietary products and
technologies, may be obtained in the Company’s filings with the
U.S. Securities and Exchange Commission (the “SEC”) at
www.sec.gov.
Forward-Looking Statement
Disclaimer
With the exception of the historical information
contained in this news release, the matters described herein may
contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. Statements
preceded by, followed by or that otherwise include the words
“believes,” “expects,” “anticipates,” “intends,” “projects,”
“estimates,” “plans” and similar expressions or future or
conditional verbs such as “will,” “should,” “would,” “may” and
“could” are generally forward-looking in nature and not historical
facts, although not all forward-looking statements include the
foregoing. These statements involve unknown risks and uncertainties
that may individually or materially impact the matters discussed
herein for a variety of reasons that are outside the control of the
Company, including, but are not limited to, the Company’s ability
to raise sufficient financing to implement its business plan, the
integration of a new management team, the impact of the COVID-19
pandemic on the Company’s business, operations and the economy in
general, the Company’s ability to successfully develop and
commercialize its proprietary products and technologies, and the
Company’s ability to maintain compliance with Nasdaq’s listing
requirements. Readers are cautioned not to place undue reliance on
these forward-looking statements, as actual results could differ
materially from those described in the forward-looking statements
contained herein. Readers are urged to read the risk factors set
forth in the Company’s filings with the SEC, which are available at
the SEC’s website (www.sec.gov). The Company disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor Relations Contact:CORE
IRScott Arnold516-222-2560scotta@coreir.com
Media Relations Contact:Jules
AbrahamDirector of Public RelationsCORE
IR917-885-7378julesa@coreir.com
Guardion Health Sciences (NASDAQ:GHSI)
Historical Stock Chart
From Feb 2024 to Mar 2024
Guardion Health Sciences (NASDAQ:GHSI)
Historical Stock Chart
From Mar 2023 to Mar 2024