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Pin to quick picksFaron Pharma Regulatory News (FARN)

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Update on INTEREST Phase III Study from IDMC

8 May 2017 07:00

RNS Number : 3975E
Faron Pharmaceuticals Oy
08 May 2017
 

Faron Pharmaceuticals Oy

("Faron" or the "Company")

 

Update on INTEREST Phase III Study for Traumakine® 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® 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 identied 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 reect 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
 
 
UPDARMMTMBJMTPR
Date   Source Headline
4th Oct 20197:20 amRNSNotice of EGM
2nd Oct 20197:00 amRNSUpdate on Traumakine drug substance manufacturing
30th Sep 20197:00 amRNSMATINS poster presentation at ESMO Congress
25th Sep 20199:13 amRNSHoldings in Company
23rd Sep 20197:08 amRNSInterim results
2nd Sep 20197:00 amRNSMATINS study selected for ESMO 2019
27th Aug 20197:00 amRNSResult of Open Offer and Further Subscription
19th Aug 20199:33 amRNSHolding(s) in Company
16th Aug 20197:00 amRNSNotice of Interim Results
6th Aug 20191:53 pmRNSIssue of Equity
5th Aug 20197:00 amRNSSubscription and Open Offer
12th Jul 20197:00 amRNSMATINS study update
5th Jul 20199:00 amRNSPrice Monitoring Extension
4th Jul 20194:40 pmRNSSecond Price Monitoring Extn
4th Jul 20194:35 pmRNSPrice Monitoring Extension
4th Jul 20192:00 pmRNSPrice Monitoring Extension
4th Jul 20199:31 amRNSHoldings in Company
1st Jul 201912:10 pmRNSGrant of options
26th Jun 20197:00 amRNSPhase II INFORAAA study update
14th Jun 20197:00 amRNSFinal results from YODA study
28th May 201912:27 pmRNSResults of AGM
24th May 20199:32 amRNSAGM update, Board & management changes
22nd May 201912:51 pmRNSGrant of Options
21st May 20199:21 amRNSHolding(s) in Company
16th May 20199:16 amRNSHolding(s) in Company
14th May 20197:01 amRNSHoldings in Company
14th May 20197:00 amRNSShare Subscription and Issue of Equity
7th May 20197:05 amRNSNotice of AGM
7th May 20197:00 amRNSFinal Results for the year ended 31 December 2018
2nd May 20195:20 pmRNSStatement regarding Price Movement
2nd May 20192:05 pmRNSSecond Price Monitoring Extn
2nd May 20192:00 pmRNSPrice Monitoring Extension
29th Apr 20197:00 amRNSResults from the Japanese Phase III study
25th Apr 20194:09 pmRNSHolding(s) in Company
12th Apr 20191:20 pmRNSHolding(s) in Company
11th Apr 20197:00 amRNSFirst expansion cohort for MATINS trial part 2
10th Apr 201911:41 amRNSHolding(s) in Company
5th Apr 20197:00 amRNSNotice of Results
2nd Apr 20199:23 amRNSHoldings in Company
29th Mar 20197:00 amRNSHolding(s) in Company
28th Mar 201912:54 pmRNSResults of the Placing and Subscription
26th Mar 20193:31 pmRNSResult of Placing and Issue Price
26th Mar 20197:00 amRNSProposed Placing to raise approximately EUR 3m
21st Feb 20197:00 amRNSMATINS study update
13th Feb 20198:57 amRNSNew data published by Clinical Cancer Research
19th Dec 20187:00 amRNSTraumakine update - YODA results
14th Dec 201811:20 amRNSFirst patient dosed in phase I/II MATINS study
11th Dec 20184:26 pmRNSHolding(s) in Company
5th Dec 20187:00 amRNSPatient subgroup identified from INTEREST trial
3rd Dec 20187:00 amRNSFaron receives CTA approval for Clevegen

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