TIDMFARN
RNS Number : 9297L
Faron Pharmaceuticals Oy
18 January 2021
Faron Pharmaceuticals Oy
("Faron" or the "Company")
US Department of Defense (DoD) to support TRAUMAKINE
development
- The DoD grants $6.1 million for the HIBISCUS study
- Faron and the US Air Force to explore Traumakine's wider
potential to prevent multi-organ failure after ischemia and
reperfusion
Company announcement, 18 January 2021 at 9.00 AM (EET)
Inside information
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company, today
announces that the US Department of Defense ("DoD") has selected
the HIBISCUS Study to receive $6.1 million of funding from the
Coronavirus Aid, Relief, and Economic Security (CARES) Act. The
Phase II/III HIBISCUS trial will assess Traumakine, Faron's IV IFN
beta-1a, for the treatment of hospitalized COVID-19 patients in the
US.
The $6.1 million funding support for HIBISCUS requires final
contracting between Faron and DoD's designated military unit, the
59(th) Medical Wing of the US Air Force, and is under preparation.
Faron has already established a working relationship with the
59(th) Medical Wing and US Army Institute of Surgical Research to
explore the use of Traumakine for organ protection in combat wounds
leading to multi-organ failure from ischemia and reperfusion.
Dr. Markku Jalkanen, Faron's CEO, said: "IFN beta-1a has
previously demonstrated a compelling argument as the body's first
line of defence against viral infection. Deficiency of either IFN
beta or the activation of its receptor (IFNAR) have been associated
with severe COVID-19 and poor outcome. This validation from the DoD
represents important progress for both our science and intravenous
IFN beta as a potential treatment for severe COVID-19 patients. We
look forward to working with the DoD, 59(th) Medical Wing of the
Air Force, University of Colorado Medical School Anschutz Campus
and Harvard to fight COVID-19 and protect central organs."
Traumakine also continues to be investigated in the ongoing
global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive
Platform Trial for Community-Acquired Pneumonia) trial, which is
evaluating potential treatments for community-acquired pneumonia,
including in COVID-19 patients, and is currently ongoing across
more than 200 sites and 19 countries.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone. +44 207 213 0880
Panmure Gordon (UK) Limited, Broker
Rupert Dearden
Phone: +44 207 886 2500
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 55 38 990
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Stern Investor Relations
Julie Seidel
Phone: +1 212 362 1200
Email: julie.seidel@sternir.com
About Faron Pharmaceuticals Ltd
Faron (AIM: FARN, First North: FARON) is a clinical stage
biopharmaceutical company developing novel treatments for medical
conditions with significant unmet needs. The Company currently has
a pipeline based on the receptors involved in regulation of immune
response in oncology and organ damage. Clevegen (bexmarilimab), its
investigative precision immunotherapy, is a novel anti-Clever-1
antibody with the ability to switch immune suppression to immune
activation in various conditions, with potential across oncology,
infectious disease and vaccine development. Currently in phase I/II
clinical development as a novel macrophage checkpoint immunotherapy
for patients with untreatable solid tumours, Clevegen has potential
as a single-agent therapy or in combination with other standard
treatments including immune checkpoint molecules. Traumakine, the
Company's pipeline candidate to prevent vascular leakage and organ
failures is currently being tested in several Phase III studies
around the world against COVID-19. Traumakine is intravenous IFN
beta-1a, which is a strong anti-viral and anti-inflammatory agent.
Faron is based in Turku, Finland. Further information is available
at www.faron.com
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identified by their use of terms and phrases such as "believe",
"could", "should", "expect", "hope", "seek", "envisage",
"estimate", "intend", "may", "plan", "potentially", "will" or the
negative of those, variations or comparable expressions, including
references to assumptions. These forward-looking statements are not
based on historical facts but rather on the Directors' current
expectations and assumptions regarding the Company's future growth,
results of operations, performance, future capital and other
expenditures (including the amount, nature and sources of funding
thereof), competitive advantages, business prospects and
opportunities. Such forward looking statements reflect the
Directors' current beliefs and assumptions and are based on
information currently available to the Directors.
A number of factors could cause actual results to differ
materially from the results and expectations discussed in the
forward-looking statements, many of which are beyond the control of
the Company. In particular, the early data from initial patients in
the MATINS trial may not be replicated in larger patient numbers
and the outcome of clinical trials may not be favourable or
clinical trials over and above those currently planned may be
required before the Company is able to apply for marketing approval
for a product. In addition, other factors which could cause actual
results to differ materially include the ability of the Company to
successfully licence its programmes within the anticipated
timeframe or at all, risks associated with vulnerability to general
economic and business conditions, competition, environmental and
other regulatory changes, actions by governmental authorities, the
availability of capital markets or other sources of funding,
reliance on key personnel, uninsured and underinsured losses and
other factors. Although any forward-looking statements contained in
this announcement are based upon what the Directors believe to be
reasonable assumptions, the Company cannot assure investors that
actual results will be consistent with such forward looking
statements. Accordingly, readers are cautioned not to place undue
reliance on forward looking statements. Subject to any continuing
obligations under applicable law or any relevant AIM Rule
requirements, in providing this information the Company does not
undertake any obligation to publicly update or revise any of the
forward-looking statements or to advise of any change in events,
conditions or circumstances on which any such statement is
based.
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