Traumakine Data Presented at MHSR Symposium
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:
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Faron Pharmaceuticals
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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.
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