Invero Pharma Secures Exclusive Xenon Clinical Supply Agreement

3/1/23, 4:16 PM Invero Pharma Secures Exclusive Xenon Clinical Supply Agreement https://www.einpresswire.com/article_print/611182567/invero-pharma-secures-exclusive-xenon-clinical-supply-agreement 1/2 — Timo Laitio, MD, PHD The Phase 2 demonstrated that xenon lessens significantly both myocardial and white matter ischemic injury.” Invero Pharma Secures Exclusive Xenon Clinical Supply Agreement A life-saving Orphan Drug for cardiac arrest patients which has been awarded FDA Fast-Track status is moving forward to phase 3 development after key agreement. MONTVILLE, NEW JERSEY, USA, January 17, 2023 /EINPresswire.com/ -- Invero Pharma2, LLC announces it has entered an exclusive supply agreement with Linde3 to provide xenon gas, the active ingredient in Invero’s XENEX® (xenon gas for inhalation), for Invero’s pivotal Phase 3 trial, known as Xenon for Cardiac Arrest Neuroprotection1 (XeCAN). XENEX® is an investigational therapy, the safety and efficacy, of which, has not yet been established. The population to be studied is post-cardiac arrest patients in both the US and Europe, with the goal of significantly improving survivability and functional neurological outcomes in resuscitated patients. In the United States alone, over 550,000 cardiac arrests are estimated to occur each year, with about two thirds occurring out of hospital (OHCA). An effective initial emergency response, including quickly administration of CPR, AED availability, and advanced EMT resuscitation measures are critical to achieve survival prior to hospital admission. Sadly, only an estimated 20% of OHCA patients survive to be treated in the hospital, and only 50% of these patients survive to discharge. Although the survival rate of patients suffering cardiac arrest in a hospital is higher due to the timeliness of resuscitative treatment, the mortality rate is still extremely high The current standard of care in the hospital consists of treating the patient with oxygen and cooling the body, generally with targeted temperature management (TTM) for 24 to 48 hours in the ICU. XENEX, when added to in-hospital standard of care, has been shown to prevent brain and heart tissue damage leading to improved survival rates in a Phase 2 clinical trial (JAMA, 2016). Timo Laitio, MD, PhD, Associate Prof. Anesthesiology & Intensive Care, University of Turku, and lead investigator of the Phase 2 trial commented, “The Phase 2 demonstrated that xenon lessens significantly both myocardial and white matter ischemic injury. Therefore, xenon will likely be the new standard of care if the results of Phase 2 are replicated and translated into clinical outcome benefit in the Phase 3.” Graham Nichol, MD, MPH, Professor of Medicine and Emergency Medicine, University of Washington, a renowned expert in resuscitation and the head of the Resuscitation Outcomes Consortium commented, “There is an unmet need for treatments to reduce death and disability after out of hospital cardiac arrest. Xenon gas reduces cell injury and cell death after restoration of blood flow. A pilot study showed that xenon is neuroprotective. A large trial that shows xenon improves clinical outcomes after cardiac arrest would address this unmet need.” Eric Weisholtz, Vice President, Healthcare of Linde commented “Gases have long played an important role in patient treatment and recovery, not least medical oxygen through the covid pandemic. Linde is one of only a few industrial gas companies worldwide, that produces xenon, an extremely rare gas, at the purity and volume necessary for this type of clinical research. We are proud to work with Invero Pharma to support this significant clinical trial.” Doug Stefanelli, Invero Pharma President and CEO commented, “Cardiac arrest awareness has never been greater after witnessing the devastating event that occurred earlier this month on Monday Night Football, when Buffalo Bills’ Damar Hamlin’s heart stopped after making a tackle on the football field. In union with the entire country, we share in the joy that Damar has been released from the hospital and is on the road to recovery. Our thoughts and prayers remain with Damar, his family and friends, and the entire Bills organization as he continues improving through rehabilitation. This makes our partnership with Linde to address this important unmet medical need all the more meaningful. We are pleased about our supply relationship with Linde, a global leader in industrial, specialty and medical gas production and distribution, to supply xenon for our post cardiac arrest trial. We look forward to working together with Linde to initiate the XeCAN trial and expanding our working relationship from research to commercialization. It is critical to bring this potentially lifesaving technology to cardiac arrest patients around the world.” About Linde - Linde is a leading global industrial gases and engineering company with 2021 sales of $31 billion (€26 billion). We live our mission of making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful and helping to sustain and protect our planet. The company serves a variety of end markets including chemicals & energy, food & beverage, electronics, healthcare, manufacturing, metals and mining. Linde's industrial gases are used in countless applications, from life-saving oxygen for hospitals to high-purity & specialty gases for electronics manufacturing, hydrogen for clean fuels and much more. Linde also delivers state-of-the-art gas processing solutions to support customer expansion, efficiency improvements and emissions reductions. 3/1/23, 4:16 PM Invero Pharma Secures Exclusive Xenon Clinical Supply Agreement https://www.einpresswire.com/article_print/611182567/invero-pharma-secures-exclusive-xenon-clinical-supply-agreement 2/2 For more information about the company and its products and services, please visit www.linde.com About Invero Pharma - Invero Pharma is a biopharmaceutical company currently exploring prospective partnerships and investments to advance its Phase 3 program for XENEX® (xenon gas for inhalation) as a neuroprotective agent for post cardiac arrest patients, as well as pursuing Phase 2 studies in stroke and TBI (Traumatic Brain Injury). Invero is a joint venture between Invero Health, LLC and JMB Capital Partners Lending, LLC. About XENEX® (xenon gas for inhalation) - XENEX® is a late-stage neuroprotective agent with a unique multi-modal mechanism of action that has been demonstrated to have organ sparing properties in post-cardiac arrest patients. XENEX® is an investigational therapy, the safety and efficacy, of which, has not yet been established. XENEX® has received Orphan Designation by both the FDA and EMA, as well as an agreement on a single pivotal Phase 3 trial with an FDA Special Protocol Assessment and EMA equivalent in place. XENEX® has also been awarded FDA Fast Track status. For more information about Invero Pharma and XENEX®, please visit www.inveropharma.com Matthew Napoletano Invero Pharma LLC [email protected] 1 https://link.springer.com/article/10.1007/s00134-021-06548-2 2 https://www.inveropharma.com 3 http://www.linde.com © 1995-2023 Newsmatics Inc. All Right Reserved. 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