Faron Pharmaceuticals Oy INFORAAA trial receives recommendation from IDMC (7197Z)
December 19 2017 - 2:00AM
UK Regulatory
TIDMFARN
RNS Number : 7197Z
Faron Pharmaceuticals Oy
19 December 2017
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Study update: Traumakine(R) Phase II/III INFORAAA trial for
Multi-Organ Failure receives recommendation from IDMC
First recommendation received from the IDMC to continue study as
planned
TURKU - FINLAND, 19 December 2017 - Faron Pharmaceuticals Ltd
("Faron") (AIM: FARN), the clinical stage biopharmaceutical
company, announces that it has received the first recommendation
from the Independent Data Monitoring Committee (IDMC) of the
INFORAAA study to continue the trial as planned using Faron's
wholly owned lead product, Traumakine(R) . The study currently has
six open sites in Finland, two in Lithuania and one in Estonia. The
first sites in the UK will open in the beginning of 2018. The
INFORAAA study aims to treat a total of 160 post-operative Ruptured
Abdominal Aorta Aneurysm (RAAA) patients and the interim results
are expected in H2 2018.
The Phase II/III INFORAAA clinical trial of Traumakine for the
treatment of Multi-Organ Failure (MOF) and mortality prevention in
surgically operated RAAA patients is based on a similar treatment
regimen to the regimen used in patients in the Company's recently
completed Phase III INTEREST trial for Acute Respiratory Distress
Syndrome (ARDS). The high mortality rate of RAAA, which accounts
for 4-5 deaths per 100,000 population (Karthikesalingam et al.,
2014), requires new treatments to prevent post-operative
reperfusion injury, the principal cause leading to the death of
RAAA patients, who demonstrate a 30-50% mortality rate
post-operatively. RAAA accounts for 13-14/100,000 hospital
admissions annually (Anjum et al., 2012), and is Faron's second
indication for Traumakine in clinical evaluation.
Patients with RAAA frequently experience Systemic Inflammatory
Response Syndrome (SIRS), despite successful open surgical repair,
which can especially affect the heart, lungs, kidneys, and
intestines. The death of approximately 80% of the operated RAAA
patients is caused by MOF, similar to patients with Acute
Respiratory Distress Syndrome (ARDS). The Directors of Faron
consider that data seen to date support the rationale for extending
the use of Traumakine in similar conditions to potentially treat
single, and multiple, organ failures. Data demonstrated during the
Traumakine Phase I/II study showed a reduced need for haemodialysis
(an indication of improved kidney function) among the ARDS patients
dosed with Traumakine.
Separately, in Faron's Phase III INTEREST trial of Traumakine,
the Company recently completed recruiting patients being studied
for the treatment of moderate to severe ARDS. Top-line data from
the INTEREST trial is due in H1 2018. In September 2017 Faron
received advice from US FDA to proceed directly to BLA submission
following completion of EU and Japanese Phase III studies. In
October 2017, Faron received notification from the United Kingdom's
Medicines and Healthcare Products Regulatory Agency (MHRA) that
Traumakine was granted Promising Innovative Medicines (PIM)
designation. There is currently no approved pharmaceutical
treatment for ARDS.
Dr Markku Jalkanen, CEO of Faron, said: "This is another piece
of good news for Faron during a highly successful year and we are
now focused on demonstrating that our wholly-owned lead product,
Traumakine, has applicability in RAAA patients as well as in the
ARDS indication. RAAA patients go through a serious surgical
procedure which currently often results in major organ failure.
This study is designed to demonstrate that major organs including
the kidney, liver and GI-tract could recover if patients are dosed
with Traumakine. 2018 is well set to be a pivotal year for Faron
given our Phase III INTEREST read out in H1 and we look forward to
the coming months with great confidence."
About Ruptured Abdominal Aortic Aneurysm (RAAA)
Ruptured Abdominal Aortic Aneurysm (RAAA) is a surgical
emergency with an overall mortality of 70 to 80%. It requires
immediate surgery and aortic repair. Approximately half of the
deaths of RAAA patients are due to not reaching the hospital in
time, and despite immediate surgery and intensive care treatment,
the second half dies in hospital within 30 days post-operatively,
mostly due to multi-organ failure. The cause of high post-operative
mortality is mainly due to prolonged hypotension/hypoxia from the
ruptured aorta and the aftermath of restoring blood flow:
reperfusion, vascular leakage and failure of vital organs.
Currently there are an estimated 40,000 US and European patients
per annum eligible for the treatment.
For more information please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Philippa Gardner, 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
Panmure Gordon (UK) Limited, Nomad and Broker
Freddy Crossley (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
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 and in 2017 received advice from US FDA to proceed directly
to BLA submission following completion of EU and Japanese Phase III
studies. 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 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.faron.com
This information is provided by RNS
The company news service from the London Stock Exchange
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