Algernon Receives Positive Feedback from U.S. FDA for Ifenprodil
COVID-19 Human Trial; Appoints U.S. Ambassador (Rtd) Howard Gutman
to Advisory Board
VANCOUVER, British Columbia, Canada -- April 13, 2020 --
InvestorsHub NewsWire -- Algernon Pharmaceuticals
Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company”
or “Algernon”) a clinical stage pharmaceutical
development company, is pleased to announce that it has received
positive feedback from the U.S. Food and Drug Administration (FDA)
regarding the Company’s plans to conduct a phase 2 COVID-19
clinical trial using its repurposed drug NP-120 (Ifenprodil).
Based on the feedback, the Company plans to
submit, as soon as possible, an Investigational New Drug (IND)
application to the FDA, to conduct a Phase 2 clinical trial with
Ifenprodil, as a therapy for patients who experience respiratory
complications as a result of contracting COVID-19.
“We are very pleased with the expedited response
we received from the FDA on our pre-IND application,” said
Christopher J. Moreau CEO of Algernon. “This is the first time
Ifenprodil has been presented to the FDA in a formal process and
their response was very encouraging.”
The Company is also pleased to announce the
appointment of U.S. Ambassador (Rtd) Howard Gutman,
former United States Ambassador to Belgium, to the
Company’s newly created Business Advisory Board.
Ambassador (Rtd) Gutman acted, during his
distinguished career over the past three decades, as a leading
American and international lawyer, and served in a number of
high-profile appointments for the government of the United
States, including Ambassador to Belgium, and Special Assistant
to the Director of the FBI for Counter-Intelligence and
Counter-Terrorism. During his legal career he served as a
United States Supreme Court and federal appellate court law clerk
prior to entering private practice in Washington, DC., where
in addition to legal practice, he served as advisor to candidates
for President, Governor and the U.S. Senate.
“Ambassador (Rtd) Gutman is an accomplished
diplomat spanning decades of experience in both private and public
sectors, and is also a widely-featured commentator, guest speaker
and media guest,” said Moreau. “He brings a wealth of knowledge and
expertise to his advisory position, which will help prepare
Algernon as we advance into the next stage of development.”
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is
an N-methyl-D-aspartate (NMDA) receptor antagonist
specifically targeting the NMDA-type subunit 2B (Glu2NB).
Ifenprodil prevents glutamate signalling. The NMDA receptor is
found on many tissues including lung cells and T-cells.
The Company believes NP-120 (Ifenprodil) can
reduce the infiltration of neutrophils and T-cells into the lungs
where they can each release glutamate and cytokines respectively.
The latter can result in the highly problematic cytokine storm that
contributes to the loss of lung function and ultimately death as
has been reported in COVID-19 infected patients.
Additional Information:
The Company also announces the launch of a new shareholder
communications initiative designed to improve visibility into the
Company’s current and planned operations. The Company has retained
South Florida based Midam Ventures LLC (Midam) to assist in the
execution of this initiative.
The Company has retained Midam for a period beginning April 8, 2020
and ending on June 30, 2020. For services provided to the
Company, Midam has been paid a total cash fee of US $250K. No
additional shares, options and or warrants were paid to Midam.
This new shareholder communications initiative is comprehensive and
will include text, image & video content disseminated by Midam
with the Company retaining full editorial control. Online traffic
will be strategically driven to approved content. The program will
also include updates to the Company’s website and social media
initiatives and strategy.
The Company also announces that it has granted, effective April 13,
2020, an aggregate of 4,550,000 stock options (each an
"Option") to certain directors, officers, and
consultants of the Company in accordance with the Company's stock
option plan. Each Option is exercisable into one Share at a price
of CDN$0.29 per Share until April 13, 2025. The options have vested
immediately and are subject to a 4-month hold.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that
investigates safe, already approved drugs for new disease
applications, moving them efficiently and safely into new human
trials, developing new formulations and seeking new regulatory
approvals in global markets. Algernon specifically investigates
compounds that have never been approved in the U.S. or Europe to
avoid off label prescription writing.
Algernon has filed new intellectual property rights globally for
NP-120 (Ifenprodil) for the treatment of respiratory diseases and
is working to develop a proprietary injectable and slow release
formulation.
The Company cautions that it is in
the early stages of clinical research and
development and is not making any express or implied claims that
NP-120 Ifenprodil is an effective treatment for the
COVID-19 virus at this time.
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.
The CSE does not accept
responsibility for the adequacy or accuracy of this
release.
Neither the Canadian Securities
Exchange nor its Market Regulator (as that term is defined in the
policies of the Canadian Securities Exchange) accepts
responsibility for the adequacy or accuracy of this release. The
Canadian Securities Exchange has not in any way passed upon the
merits of the proposed transaction and has neither approved nor
disapproved the contents of this press release.
CAUTIONARY DISCLAIMER STATEMENT: No
Securities Exchange has reviewed nor accepts responsibility for the
adequacy or accuracy of the content of this news release. This news
release contains forward-looking statements relating to product
development, licensing, commercialization and regulatory compliance
issues and other statements that are not historical facts.
Forward-looking statements are often identified by terms such as
“will”, “may”, “should”, “anticipate”, “expects” and similar
expressions. All statements other than statements of historical
fact, included in this release are forward-looking statements that
involve risks and uncertainties. There can be no assurance that
such statements will prove to be accurate and actual results and
future events could differ materially from those anticipated in
such statements. Important factors that could cause actual results
to differ materially from the Company’s expectations include the
failure to satisfy the conditions of the relevant securities
exchange(s) and other risks detailed from time to time in the
filings made by the Company with securities regulations. The reader
is cautioned that assumptions used in the preparation of any
forward-looking information may prove to be incorrect. Events or
circumstances may cause actual results to differ materially from
those predicted, as a result of numerous known and unknown risks,
uncertainties, and other factors, many of which are beyond the
control of the Company. The reader is cautioned not to place undue
reliance on any forward-looking information. Such information,
although considered reasonable by management at the time of
preparation, may prove to be incorrect and actual results may
differ materially from those anticipated. Forward-looking
statements contained in this news release are expressly qualified
by this cautionary statement. The forward-looking statements
contained in this news release are made as of the date of this news
release and the Company will update or revise publicly any of the
included forward-looking statements as expressly required by
applicable law.
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