Faron Pharmaceuticals Oy First patient recruited in Japanese Ph III trial (2342N)
24 October 2016 - 5:00PM
UK Regulatory
TIDMFARN
RNS Number : 2342N
Faron Pharmaceuticals Oy
24 October 2016
Faron Pharmaceuticals Oy
("Faron" or the "Company")
First Traumakine(R) Phase III patient in Japan recruited for the
treatment of acute respiratory distress syndrome
and
Update on Pan-European Phase III Traumakine trial
TURKU - FINLAND, 24 October 2016 - Faron Pharmaceuticals Ltd
("Faron") (LON: FARN), the clinical stage biopharmaceutical
company, is pleased to announce that its Japanese licensing partner
Maruishi Pharmaceutical Co., Ltd. ("Maruishi") has recruited the
first patient in the Japanese Phase III pivotal clinical trial for
the treatment of acute respiratory distress syndrome ("ARDS") with
FP-1201-lyo (also known as Traumakine(R)).
Faron has also recently received the second IDMC (Independent
Data Monitoring Committee) recommendation to continue the INTEREST
pan-European Phase III trial with Traumakine without any
modifications.
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. An earlier Phase I/II trial conducted in the
UK and published in The Lancet Respiratory Medicine, (Bellingan et
al. 2014: 2: 98-107), showed a decline in the odds of all-cause
mortality at day 28 of 81%. A Japanese Phase II trial was completed
with comparable mortality results and no observed severe adverse
events as announced in January 2016.
The Japanese Phase III clinical trial (JapicCTI-163320) is a
double-blinded, randomised, parallel-group comparison of efficacy
and safety of FP-1201-lyo against placebo in the treatment of
maximum 120 patients with moderate to severe ARDS. The initiation
of the Japanese study means that the Pan-European and Japanese
Phase III trials combined aim to treat maximum 420 moderate to
severe ARDS patients with results expected to become available in
2017-2018.
Dr Markku Jalkanen, CEO of Faron said: "We are delighted that
patient recruitment for the Japanese Phase III trial has commenced
as this trial will significantly increase the total number of
patients in Traumakine pivotal studies. It was also encouraging to
receive the second IDMC recommendation for the INTEREST
pan-European Phase III trial continuation demonstrating the studies
are progressing in line with protocol expectations and design."
The information contained within this announcement constitutes
inside information stipulated under the Market Abuse Regulation
(EU) No. 596/2014.
For more information please contact:
Faron Pharmaceuticals Ltd
Katja Wallenlind
Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com
Hume Brophy, PR
Mary Clark, Eva Haas, Hollie Vile
Phone: +44 207 862 6390
E-mail: faron@humebrophy.com
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson, Rebecca Anderson
Phone: +44 207 148 7900
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
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
About Faron Pharmaceuticals Ltd
Faron 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, cancer immunotherapy and vascular damage. The pipeline is
built on Faron's scientific knowledge and control of the
endothelial barrier, the membrane of cells lining blood and
lymphatic vessels to separate blood content from tissues. The
Company's lead candidate Traumakine(R) is in development for the
treatment of Acute Respiratory Distress Syndrome ("ARDS"), a rare,
severe, life-threatening medical condition characterised by
widespread inflammation in the lungs. Traumakine is currently in
pan-European (INTEREST) and Japanese pivotal Phase III studies.
Additionally, Faron is developing Clevegen(R) a ground breaking
pre-clinical anti-Clever-1 antibody. Clevegen has the ability to
convert the immune environment around a tumour from being immune
suppressive to immune stimulating. This novel macrophage-directed
immuno-oncology approach is called Tumour Immunity Enabling
Technology ("TIET") and can be used alone or in combination with
other immune checkpoint molecules for the treatment of cancer
patients. New application opportunities related to TIET cover
chronic infections and inefficient vaccination. Based in Turku,
Finland, Faron Pharmaceuticals is listed on AIM under the ticker
'FARN'. Further information is available at
www.faronpharmaceuticals.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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