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Pin to quick picksFaron Pharma Regulatory News (FARN)

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Traumakine Data Presented at MHSR Symposium

13 Sep 2022 07:00

RNS Number : 1787Z
Faron Pharmaceuticals Oy
13 September 2022
 

Faron Pharmaceuticals Ltd.

("Faron" or "Company")

 

Traumakine Data on Multi-Organ Dysfunction and Limb Salvage to be Presented at the Military Health System Research Symposium

 

· Data further highlights promise of intravenous interferon beta-1a therapy as potential therapeutic for emergency and trauma patients, especially when given early on

· Primates treated with Traumakine at the time of major inflammation due to ischemia showed lower levels of muscle and liver damage markers indicating total body protection

· Full restoration of limb function seen with no evidence of muscle atrophy or degeneration

· Results align with previously conducted INFORAAA clinical trial where Traumakine showed systemic protection in the form of survival benefit and kidney protection in a setting of multi-organ failure

 

Press release, September 13, 2022, at 02:00 AM (EDT) / 07:00 AM (BST) / 09:00 AM (EEST)

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that data from the preclinical Salvage, Preservation, and Advanced Resuscitation through Endothelial Stabilization (SPARES) study will be presented at the Military Health System Research Symposium (MHSRS) being held in Orlando, Florida, from September 12 - 15, 2022. The data (Abstract ID: MHSRS-22-06010) will be featured in the "Multi-Organ Dysfunction in Prolonged Field Care Scenarios" breakout session today from 10:00 AM - 12:00 PM EDT.

 

The SPARES study was a preclinical study, conducted on non-human primates (a representative model for humans), to understand the potential effects of Traumakine, Faron's investigational intravenous interferon beta-1a therapy, on limb salvage and preventing multiple organ dysfunction in prolonged field care scenarios where blood flow to a significantly wounded limb is closed for rescue and transportation. The study was coordinated in conjunction with investigators from Wake Forest Health, Duquesne University, the 59th Medical Wing of the US Air Force and with funding from the US Department of Defense.

 

Traumakine works by up-regulating CD73, a key organ protective endothelial enzyme that reduces inflammation and prevents vascular leakage. The study results showed a reduction in blood markers of muscle, liver, and kidney damage among animals treated with Traumakine. Repeated muscle biopsies in those animals showed a marked absence of immune cell infiltration, preservation of integrity of muscle bundles, no evidence of fibre atrophy or contraction bands in histopathology. The animals experienced significantly better recovery compared to control animals that were not treated. The study investigators believe this is likely to translate well into a human setting.

 

The results provide further evidence to support the systemic protective effect of intravenous administration of interferon beta, which was previously reported in Faron's INFORAAA study (Hakovirta et al 2022), a human clinical trial to prevent multiple organ dysfunction. In the INFORAAA study patients who responded to Traumakine had 100% survival at Day 90 compared to 66% survival among non-responders. Systemic organ protection, such as lower levels of kidney damage, was also seen in responders.

 

"Results of the SPARES study showed that following treatment with Traumakine, there was no evidence of muscle atrophy or degeneration at 28 days, reaffirming my excitement in the potential of intravenous interferon beta to counteract widespread inflammation and decreased blood flow that, together, can result in limb loss and multi-organ dysfunction syndrome," said Principal Investigator, Professor Vijay S. Gorantla, M.D., Ph.D., Professor of Surgery at Wake Forest Institute for Regenerative Medicine and President of the International Society of Vascularized Composite Allotransplantation. "This promising evidence supports further trials with Traumakine to understand its potential military application and in human surgical procedures where ischemic organs are often seen."

 

"Once again we are reminded of the importance of the key endothelial enzyme CD73, and this data demonstrates the potential patient benefit within major ischemic and inflammatory settings," said Juho Jalkanen, M.D., Ph.D. MSc, Chief Operating Officer of Faron. "The presentation of these data at such a prestigious conference within the military community underscores how Traumakine holds the promise to be an important 'golden hour' therapeutic within combat scenarios where there remains a serious unmet need."

 

The MHSRS is the US Department of Defense's foremost scientific meeting and the premier military or civilian meeting focused specifically on the unique medical needs of the war fighter. It provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related health care initiatives falling under the topic areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Medical Simulation and Information Sciences, Military Infectious Diseases, and the Radiation Health Effects.

 

Poster presentations will be added to the "Investor" section on Faron's website at https://www.faron.com/investors.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6069

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalized patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma. Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Forward Looking Statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should", "expect", "hope", "seek", ''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 reflect 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 and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, 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 or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. 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 Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
 
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NRAEAXNAFLFAEFA
Date   Source Headline
21st Mar 20187:00 amRNSNotice of Full Year Results
6th Mar 201812:54 pmRNSHolding(s) in Company
5th Mar 201810:12 amRNSHolding(s) in Company
2nd Mar 20181:30 pmRNSHolding(s) in Company
2nd Mar 20181:25 pmRNSHolding(s) in Company
1st Mar 201812:42 pmRNSHoldings in Company
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26th Feb 20181:37 pmRNSIssue of Equity
21st Feb 20183:31 pmRNSResults of Placing & Issue of Equity
21st Feb 20187:00 amRNSFaron hosts R&D Day today in London
16th Feb 20187:00 amRNSProposed Placing to raise up to £15m
5th Feb 20187:00 amRNSSecond Traumakine manufacturing site established
1st Feb 20187:00 amRNSFaron Announces Clevegen Grant of European Patent
29th Jan 20187:00 amRNSFDA grants Fast Track Designation for Traumakine®
24th Jan 20187:00 amRNSFDA approval of Faron's Traumakine® IND
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14th Dec 20177:00 amRNSFaron announces R&D Day in February 2018
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1st Dec 20177:01 amRNSAppointment of Chief Commercial Officer
24th Nov 201710:23 amRNSHolding(s) in Company
21st Nov 20177:00 amRNSGrant of options
20th Nov 20177:00 amRNSChange of Adviser
16th Oct 20179:00 amRNSHolding(s) in Company
13th Oct 20179:00 amRNSDirector/PDMR Shareholding
11th Oct 20172:00 pmRNSIssue of Equity & PDMR Shareholding
9th Oct 20174:30 pmRNSResult of Placing & Subscription & Issue of Equity
5th Oct 20177:00 amRNSProposed Placing and Subscription
2nd Oct 20177:00 amRNSTraumakine Receives PIM Designation from MHRA
11th Sep 20173:19 pmRNSDirectors Dealings
6th Sep 20177:00 amRNSInterim Results
4th Sep 20177:00 amRNSFDA advises Faron to proceed directly to BLA
4th Aug 20177:00 amRNSUpdate on INTEREST Phase III Study from IDMC
28th Jul 20179:34 amRNSHolding(s) in Company
10th Jul 20174:51 pmRNSHolding(s) in Company
10th Jul 20177:00 amRNSNotice of Results
16th Jun 20172:43 pmRNSDirector/PDMR Shareholding
1st Jun 20177:00 amRNSExercise of Warrants and Options
30th May 20172:06 pmRNSHoldings in Company
22nd May 201711:31 amRNSDirector/PDMR Shareholding
22nd May 20177:00 amRNSDirector/PDMR Shareholding
18th May 20179:20 amRNSDirector/PDMR Shareholding
16th May 201712:00 pmRNSResult of AGM
8th May 20174:40 pmRNSSecond Price Monitoring Extn
8th May 20174:35 pmRNSPrice Monitoring Extension
8th May 20177:00 amRNSUpdate on INTEREST Phase III Study from IDMC
27th Apr 20175:57 pmRNSExercise of Warrants
26th Apr 201712:32 pmRNSDirector's dealings
21st Apr 20175:56 pmRNSDirector/PDMR Shareholding

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