TIDMFARN
RNS Number : 3975E
Faron Pharmaceuticals Oy
08 May 2017
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Update on INTEREST Phase III Study for Traumakine(R) in ARDS
from IDMC
TURKU - FINLAND, 08 May, 2017 - Faron Pharmaceuticals Ltd
("Faron") (LON: FARN), the clinical stage biopharmaceutical
company, announces that it has received an expected report dated
4th May 2017 from the Independent Data Monitoring Committee (IDMC)
on the INTEREST Phase III study for the treatment of patients with
moderate to severe Acute Respiratory Distress Syndrome (ARDS) with
its lead product Traumakine.
At this fourth meeting the IDMC has recommended to Faron that
the trial should continue as planned with no changes, consistent
with the recommendation received from IDMC as a result of three
previous meetings. The IDMC also informed Faron that they will
provide the next advanced recommendation after reviewing the data
at 240 recruited patients. The Company expects this to take place
during the third quarter of 2017.
ARDS is a severe orphan disease with a reported mortality rate
of approximately 30-45%, for which there is currently no approved
pharmacological treatment. It is characterised by widespread
capillary leakage and inflammation in the lungs, most often as a
result of pneumonia (e.g. following a pandemic influenza), sepsis,
or significant trauma with around 300,000 annual cases in Europe
and US.
The INTEREST trial is a Phase III double-blind, randomised,
parallel-group comparison of efficacy and safety of Traumakine
(FP-1201-lyo) and placebo in the treatment of patients with
moderate to severe ARDS. The study, designed to include up to 300
patients, is currently being conducted in 60 hospital intensive
care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain
and UK. The primary efficacy endpoint in the INTEREST trial is the
all-cause mortality rate at day 28, the only accepted primary end
point for marketing approval by EMA. The INTEREST trial protocol is
targeting a 50% reduction in all cause mortality at day 28 between
placebo and treatment arm (from 30% to 15%).
Dr Markku Jalkanen, Chief Executive Officer of Faron
Pharmaceuticals, commented: "We were again very delighted to learn
that the IDMC gave us another recommendation to continue the
INTEREST study as planned. We are looking forward to their next
recommendation in Q3 2017, which we hope to confirm our plans for
the future of the product and for ARDS patients."
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulation (EU) No. 596/2014. Upon the publication of this
announcement, this inside information is now considered to be in
the public domain.
- END -
For more information, please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faronpharmaceuticals.com
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson
Phone: +44 207 213 0880
Panmure Gordon (UK) Limited, Joint Broker
Freddy Crossley, Duncan Monteith (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
Whitman Howard Limited, Nominated Broker (UK)
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company
developing novel treatments for medical conditions with significant
unmet needs. The Company currently has a pipeline focusing on acute
organ traumas, vascular damage and cancer immunotherapy. The
Company's lead candidate Traumakine, to prevent vascular leakage
and organ failures, is currently the only treatment for Acute
Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical
trials. There is currently no approved pharmaceutical treatment for
ARDS. An additional European Phase II Traumakine trial is underway
for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's
second candidate Clevegen(R) is a ground breaking pre-clinical
anti-Clever-1 antibody. Clevegen has the ability to switch immune
suppression to immune activation in various conditions, with
potential across oncology, infectious disease and vaccine
development. This novel macrophage-directed immuno-oncology switch
called Tumour Immunity Enabling Technology ("TIET") may be used
alone or in combination with other immune checkpoint molecules for
the treatment of cancer patients. Faron is based in Turku, Finland.
Further information is available at
www.faronpharmaceuticals.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
identi ed by their use of terms and phrases such as "believe",
"could", "should", "expect", "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 re ect 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 discussed in the forward looking
statements including 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, reliance on key personnel,
uninsured and underinsured losses and other factors, many of which
are beyond the control of the Company. 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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