Cardiac arrest may damage the brain as well as the heart. Many studies show Xenon, an inert and non-toxic gas, may increase survival.

MONTVILLE, NEW JERSEY, USA, March 9, 2022 /EINPresswire.com/ -- XENEX^® is literally a last gasp product. It is being developed to treat patients resuscitated after cardiac arrest but who remain comatose. This condition is so dire that the only currently approved treatment is to cool the patient’s body, hoping to preserve the brain.

Xenon, an inert gas with no known toxicity and given through a proprietary ventilator, has been shown in hundreds of preclinical studies and a successful phase 2 clinical trial to have the potential to help protect the brain and the heart during the critical first 24 hours.

Invero Pharma has recently procured additional exclusive data rights from the Turku University Hospital (TUH) in Finland for its pioneering work on xenon gas. Researchers at TUH were the first to demonstrate the neuroprotective effects of xenon in humans. TUH data from a Phase 2 Study in cardiac arrest patients includes exclusive rights to a proprietary protocol, analysis, and unpublished findings, which serve as the basis for Invero Pharma’s active IND and Pivotal Phase 3 Xenon for Cardiac Arrest Neuroprotection (XeCAN) Trial, approved under an FDA Special Protocol Agreement (SPA). Based primarily on the TUH findings, the FDA and EMA have agreed to a single well-controlled pivotal study required for approval of Invero Pharma’s XENEX^® (xenon) inhalation, which has Orphan Status for neuroprotection in post-cardiac patients by both agencies. The FDA has also granted XENEX^® Fast Track status.

Timo Laitio, MD, PhD, TUH, the principal investigator said, “The Phase 2 clinical trial 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 the Phase 2 studies are replicated and translated into clinical outcome benefit in the Phase 3.”

Doug Stefanelli, Invero Pharma CEO, commented, “We are pleased to partner with Turku to further expand on their extraordinarily positive findings, as we enter the final Phase 3 study phase. The new Invero-TUH agreement also includes exclusive rights to future xenon work by the investigators, including a Phase 2 subarachnoid hemorrhagic (SAH) stroke study planned to begin the second half of 2022.”

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 inhalation as a neuroprotective agent following hypoxic-ischemic events, i.e. cardiac arrest and stroke. Invero is a joint venture between JMB Capital and Invero Health.

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^® 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.
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Douglas Stefanelli
Invero Pharma LLC
+1 862-800-7788
dstefanelli@inveropharma.com
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