REG - Faron Pharma. Oy - Scientific Reports Publishes INFORAAA Results

Faron Pharmaceuticals OyAnnouncement

03/02/2022 10:40

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RNS Number : 6200A  Faron Pharmaceuticals Oy  03 February 2022

Faron Pharmaceuticals Ltd

("Faron")

 

Scientific Reports Publishes INFORAAA Results Showing Traumakine-Induced
Up-Regulation of CD73

Prevents Death After Emergency Open Aortic Surgery

 

·      Induction of CD73 molecule prevents death after emergency open
aortic surgery

·      Up-regulation of CD73 was associated with 100% survival compared to expected mortality between 30-40%

 

 

Company announcement, February 3, 2022 at 05:40 AM (EST) / 10:40 AM (GMT) /
12:40 PM (EET)

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Ltd (AIM: FARN, First
North: FARON), a clinical stage biopharmaceutical company focused on building
the future of immunotherapy by harnessing the power of the immune system to
tackle cancer and inflammation, today announces that the multidisciplinary
journal Scientific Reports from the Nature Publishing Group published research
highlighting results from Faron's Phase II INFORAAA clinical trial. The paper,
titled "Induction of CD73 prevents death after emergency open aortic surgery
for a ruptured abdominal aortic aneurysm: a randomized, double-blind,
placebo-controlled study" (6bc2c5da-75ff-4538-9bf8-ab69f809318c) is available
online at: www.nature.com/articles/s41598-022-05771-1
(http://www.nature.com/articles/s41598-022-05771-1) .

 

The INFORAAA study examined the effect of Traumakine (Intravenous Interferon
beta-1a; IFN beta-1a) on mortality of surgically operated ruptured abdominal
aorta aneurysm (RAAA) patients. These patients are at high risk of
ischemia-reperfusion injury, which is tissue damage caused when blood supply
returns to tissue after a period of oxygen depletion. Ischemia-reperfusion
injury leads to systemic inflammation and multi-organ failure, which is the
main cause of death for operated RAAA patients with expected mortality between
30-40%. Traumakine works by up-regulating CD73, a key organ protective
endothelial enzyme that reduces inflammation and prevents vascular leakage.

 

Twenty-nine patients were enrolled in the treatment arm of the INFORAAA study
and 11 were enrolled in the control (placebo) arm. Patients in the treatment
arm received Traumakine once a day for six days following surgery. Mortality
was compared to the placebo arm for a period of 30 days after surgery.
Analysis showed that up-regulation of CD73 was associated with 100% survival.
As previously reported, approximately one-third of patients in the treatment
arm were treated concomitantly with corticosteroids, which abolished a CD73
response in these patients.

 

"The study clearly showed that intravenous interferon beta-1a can induce CD73
when not used with steroids or in the presence of IFN beta neutralizing
antibodies, and that patients who had high levels of CD73 survived this
complicated and invasive surgery," said Professor Maarit Venermo, M.D., Ph.D.,
Head of Vascular Surgery at Helsinki University Hospital, Secretary General of
the European Society of Vascular Surgery, and one of the coordinating
investigators of the INFORAAA trial. "In the absence of any drugs approved for
this condition, as well as complications seen in major surgery, these exciting
clinical findings warrant further research to test this drug for the
prevention of acute organ injuries."

 

Traumakine is an investigational therapy developed by Faron for the potential
treatment of acute respiratory distress syndrome (ARDS), acute kidney injury,
cardiac protection, ischemia reperfusion injury and other systemic
inflammatory conditions. It is currently being investigated in the Phase
II/III HIBISCUS trial as a first-line treatment for hospitalized COVID-19
patients. Additionally, investigations at the Wake Forest Institution of
Regenerative Medicine by Professor Vijay S. Gorantla in association with the
US Department of Defense, and ongoing work by Academician Sirpa Jalkanen,
founder of Faron Pharmaceuticals, at the University of Turku continue to
highlight the potential benefit of intravenous Interferon beta 1-a's mode of
action. Their research is focussed on the multiple applications of Interferon
for systemic inflammatory conditions and translating this into the clinic.

 

"I continue to be excited by the potential of IV Interferon beta-1a for the
induction of CD73," said Professor Vijay S. Gorontla, M.D., Ph.D., Professor
of Surgery at Wake Forest University and President of the International
Society of Vascularized Composite Allotransplantation (a complicated
transplant where multiple tissue types are transplanted at the same time,
including bones, skin, vessels, and/or tendons). "CD73 is critical in removal
of proinflammatory cytokines in the inflammatory process and I see it having
great potential in transplantation and other conditions involving significant
cytokine release, such as major operations and polytrauma."

 

"These results highlight, once again, the importance of CD73 in organ
protection and the ability it has to benefit patients undergoing major
surgery," said Juho Jalkanen, M.D., Ph.D., Chief Operating Officer of Faron.
"We are pleased that the data was published and remain excited by the
potential of Traumakine across multiple indications where there continues to
be significant unmet medical need and no approved drug treatments."

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com (mailto:Eric.vanzanten@faron.com)

Investor.relations@faron.com

+1 (610) 529-6219

 

Investor Contact

Stern Investor Relations

Julie Seidel

julie.seidel@sternir.com (mailto:Julie.seidel@sternir.com)

Phone: +1 (212) 362-1200

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 (0) 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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 caused by dysfunction of our immune system. The Company currently
has a pipeline based on the receptors involved in regulation of immune
response in oncology, organ damage and bone marrow regeneration. Bexmarilimab,
a novel anti-Clever-1 humanized antibody, is its investigative precision
immunotherapy with the potential to provide permanent immune stimulation for
difficult-to-treat cancers through targeting myeloid function. Currently in
Phase I/II clinical development as a potential therapy for patients with
untreatable solid tumors, bexmarilimab has potential as a single-agent therapy
or in combination with other standard treatments including immune checkpoint
molecules. Traumakine is an investigational intravenous (IV) interferon
beta-1a therapy for the treatment of acute respiratory distress syndrome
(ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is
currently being evaluated in global trials as a potential treatment for
hospitalized patients with COVID-19 and with the 59th Medical Wing of the US
Air Force and the US Department of Defense for the prevention of multiple
organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by
a major trauma. Faron is headquartered in Turku, Finland with additional
offices in Zürich, Switzerland and US operations in Boston, Massachusetts.
Further information is available at www.faron.com (http://www.faron.com) .

 

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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