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Clinical Trial Leading to Better Brain Oxygenation for Acute Ischemic Stroke Patients

 

During an ischemic stroke, quickly restoring blood flow in the blocked artery is key to both survival and a better outcome. The mortality rate for stroke has declined in recent decades in the U.S., thanks to growing awareness of the need for emergency care, improved treatment options and better management of risk factors. And physicians at Baptist Health Miami Neuroscience Institute hope to see even better outcomes for stroke patients in the future, thanks to the work they are doing to develop neuroprotective treatments specifically aimed at increasing oxygen flow in the brain following a stroke.

Italo Linfante, M.D.

Italo Linfante, M.D.

“Neuroprotection is a broad term,” says Italo Linfante, M.D., medical director of interventional neuroradiology at the Institute. “Neurons are dependent upon oxygen to live, so what we are particularly excited about are investigational medications that work to improve oxygenation and blood circulation to the brain.”

Dr. Linfante led the multi-institutional Hemera-1 clinical trial (NCT04677777). The trial studied the use of polyethylene glycol (PEG)ylated bovine carboxyhemoglobin, also known as PP-007. A carbon monoxide releasing and oxygen transfer molecule, PP-007 was proved safe in the Phase 1 study. The promising results led to its fast-track designation by the FDA and an extension trial.

“We can administer the IV medication before we give clot-busting drugs or perform a mechanical thrombectomy or we can choose to give PP-007 at the time of the procedure or even after. It opens collateral vessels, delivers oxygen to hypoxic neurons and reduces inflammation in patients with acute ischemic stroke,” he says. “In addition, we noted that the medication had a lasting effect of 24 hours, which is remarkable. We have had very good results with our patients, and, although it is a small group of patients, we are hopeful that we will have similar results as we move into larger studies.”

At the Live International Neuroradiology, Neurology and Neurosurgery Course (LINNC) Americas 2024 seminar in Miami and the 2025 International Stroke Conference in Los Angeles, Dr. Linfante shared results from the initial study, which will be published soon. He is now heading a global Phase 3 study of the medication, designed to determine if there are additional and longer-lasting patient benefits when two doses of the drug are given.

Every 40 seconds in the U.S., someone has a stroke, and one in six cardiovascular deaths is due to stroke, according to the Centers for Disease Control and Prevention. Ischemic strokes are the most common type of stroke, accounting for approximately 87 percent of all strokes.

In addition to immediate emergency treatment, outcomes are best when care occurs at experienced centers with dedicated stroke teams. The programs at Baptist Health Baptist Hospital and Boca Raton Regional Hospital, also part of Baptist Health, are designated as Comprehensive Stroke Centers by the American Heart Association/American Stroke Association and can treat the most-complex cases.

For more information about stroke care at Miami Neuroscience Institute, visit Stroke Care & Services | Baptist Health.


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