Faron Pharmaceuticals Ltd.
(“Faron” or the “Company”)
Faron Announces Traumakine Research Collaboration and DoD Grant
Press release, 13 August 2024 at 7:00 a.m. BST / 9:00 a.m. EEST
TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company with its lead immune oncology program bexmarilimab, also pursuing induction of CD73 for organ protection, announces it has joined a research consortium that has received a Department of Defense (DoD) Grant to investigate the use of intravenous interferon beta (TraumakineÒ) for the prevention of ischemia-reperfusion injury in battlefield victims when using a lifesaving torniquet for the prevention of excessive blood loss. The Study is named Resuscitation by Endothelial Stabilization and Targeted Oxygen Rescue (RESTOR) Platform for Battlefield Applications. Participating institutions are Duquesne University School of Pharmacy and Wake Forest Medical University Health Sciences.
As previously investigated under another DoD grant by the same team, TraumakineÒ was highly effective for limb salvage and prevention of systemic inflammation and organ damage when given at the time of placing the torniquet, but not when given later. In the current setting TraumakineÒ will be investigated when given as a preventative treatment prior to placing the torniquet, simulating a situation where operational units going into a mission would be pre-treated with TraumakineÒ before going into combat where injury could result in the need for a torniquet. The aim of TraumakineÒ in this setting would be to improve survival and limb salvage by attenuating ischemia-reperfusion injury if a torniquet was needed.
If the results of these upcoming pre-clinical experiments are positive, this could open an avenue for approval without extensive human clinical studies. In conditions where controlled clinical studies cannot be conducted, a drug could be approved by using pre-clinical studies simulating the intended use. As a widely used and well tolerated drug with a large amount of human exposure, interferon beta could potentially qualify as such a drug. Previous examples of such approvals also relate to defense, where the investigational drug cannot be tested in humans in the desired indication, but is proven to be safe in man while the efficacy is proven based on the mode of action and pre-clinical studies.
“We are very pleased to see the DoD’s continued support to this research group and the TraumakineÒ program. From our learnings from previous clinical trials with TraumakineÒ, we envision that the best outcomes with intravenous interferon beta can be achieved when the drug is used for the prevention, and not necessarily treatment, of systemic inflammation and organ damage. RESTOR is a pilot study to test TraumakineÒ in this preventative setting, and paid by the DoD, but if positive, it could bolster Traumakine’sÒ path to market in this setting, and the Company should consider investing further into the program or find a partner for it.” said Dr. Juho Jalkanen, Chief Executive Officer of Faron.
For more information on research collaboration, please visit: Duquesne Receives New $1.5 Million Grant to Expand Transplantation Research
https://otp.tools.investis.com/clients/uk/faron2/rns/regulatory-story.aspx?cid=2223&newsid=1853682
