A new treatment for patients with acute respiratory distress
syndrome has seen mortality rates plummet by about 80 per cent.
The results come from a phase II trial led by Dr Geoff Bellingan
at UCL Clinical Physiology and medical director at University
College London Hospitals.
Acute lung injury (ALI) and its more severe form, acute
respiratory distress syndrome (ARDS), are major causes of death in
intensive care units.
It is estimated that approximately 300,000 to 400,000 people
suffer from ARDS in Western countries each year and the mortality
rate remains high, around 35-45 per cent, despite modern day
care.
At the moment there is no effective drug treatment for the
syndrome, so patients tend to be treated with mechanical
ventilation and optimisation and support of vital functions.
Major causes of ARDS include direct lung injury such as lung
infection (pneumonia), aspiration pneumonia or indirect injuries
such as severe sepsis, major multiple trauma or pancreatitis.
But a clinical study to test the new drug developed by Faron
Pharmaceuticals Limited, demonstrated an astonishing 81 per cent
reduction in mortality in ARDS patients, with a mortality of only
8.1 per cent in patients treated with Traumakine, compared to the
32.2 per cent mortality seen in the control group of ARDS
patients.
All other measured parameters, including length of mechanical
ventilation needed, length of ICU stay and support of vital
functions also clearly benefited from the treatment.
The trial was conducted in eight intensive care units around the
UK and was led by a team of scientists and clinicians which
included UCL professor of intensive care medicine Hugh Montgomery
and UCL/UCLH intensive care clinical lead David Howell.
The results are published together with the molecular studies of
Professor Sirpa Jalkanen from Finland's University of Turku.
"Pulmonary vascular leakage occurs early in ALI/ARDS, and
mortality remains high. An effective pharmacotherapy is desperately
needed," said Dr Bellingan.
"Traumakine has been shown to reduce capillary leak and we were
very happy to see this translate into a benefit in ARDS patients as
predicted. The drug promotes the formation of a local
anti-inflammatory molecule and improves the amount of oxygen
entering the blood stream from the air," he said.
Meanwhile Dr Bellingan said he and his team were looking forward
to starting further clinical investigations.
Faron has been granted orphan drug status for the treatment of
ALI/ARDS with FP-1201-lyo (Traumakine®) by the European Commission
and European Medicines Agency (EMA) and is waiting for EMA advice
to start phase III studies.
"We are very pleased to receive the FPCLI001 trial results and
related information published in this prestigious journal", said
Faron's CEO Markku Jalkanen.
"We hope that this publication promotes our efforts to attract
active intensive care sites and clinicians to join our next step,
the pan-European phase III pivotal trial starting in 2014," said
Professor Jalkanen.
In addition to its high rate of mortality, ARDS is also a major
economic burden to hospitals and health care budgets.
It is estimated that due to a long ICU and hospital stay, the
cost of every saved life from ARDS is approximately £43,000. With a
new efficient pharmacotherapy, hospital stays are likely to become
shorter and the costs will likely diminish significantly.
The paper, The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73
expression and on acute respiratory distress syndrome mortality: an
open-label study, is published in The Lancet
Respiratory Medicine.