Clinical Trials

A stroke treatment develop by researcher Byron Ford at the University of California, Riverside, has moved toward clinical trials. The treatment focuses on neuregulins, a family of naturally occurring proteins that has shown promise for treating stroke, a leading cause of death in the United States and the major cause of long-term disability.
During stroke, blood supply to the brain is interrupted. Most often, an artery to the brain gets block by a clot or a blood vessel ruptures. With no blood and therefore no oxygen or nutrients reaching the brain; so cells in the brain begin to die locally, at the “core,” within a couple of hours.

The core cells burst

Subsequently, the core cells burst and release their components into the surrounding area; which then experiences a dramatic inflammatory response. This area, called the ischemic penumbra, dies over the course of several hours or days. Neuregulin-1, or NRG-1, one of four proteins in the neuregulin family, prevents this inflammation and cell death.
Cells in the core die by getting overexcite and exploding,” said Ford; so a professor of biomedical sciences at the UCR School of Medicine, whose company, Brain-Gen, has patents for the use of NRG-1 to treat stroke. Cells in the ischemic penumbra die by committing suicide. This happens, we believe, to prevent the whole brain from dying. An analogy: imagine a grenade is flung into a crowded theater, and a few people throw themselves on the grenade.

They will die, but due to their sacrifice, others may very likely be spared. Brain-Gen is co-own by his brother Gregory Ford, a neuroscientist. Byron Ford explaine that Zensun Biotech, a Shanghai-base Chinese company with which Brain Gen has recently partnered, has patents to use a particular form of neuregulin, called Neucardin, to treat heart failure.

Zensun Biotech does not have patents, however, for Neucardin’s use in clinical trials for stroke. Brain-Gen test Neucardin and found it works for stroke in animal models. The two companies have sign an agreement to collaboratively move Neucardin toward clinical trials for stroke and to form a joint venture.

Clinical trials for heart failure

To our advantage, Zensun has already complete phase I and phase II clinical trials for heart failure; also show that Neucardin is safe and improves heart function in patients,” Ford said. “A stroke is like a heart attack in the brain. If the FDA says we can cross reference Zensun’s data for approval to treat stroke, this would greatly expedite matters as we apply to become part of the NIH StrokeNet.
Each year, nearly 800,000 Americans have a stroke, of which about 140,000 die. The “Stroke Belt,” an area in the southeastern United States and Mississippi Valley, has the highest rate of stroke mortality in the country. Currently, the only FDA-approve drug to treat stroke is tissue plasminogen activator, or t-PA, which melts the clot.
It has no effect on brain cells, however, and can use only within a three hour window from the witness time of stroke onset; so beyond which t-PA damages blood vessels and causes bleeding. Further, only 3%-5% of stroke patients qualify for t-PA due to the limited time window and access to primary stroke centers. In contrast, Neucardin can be given to a patient; which is more than 12 hours after a stroke and has show to be safe in patients.
Ford proposes that Neucardin be administer intravascularly to the patient along with t-PA to offer protection to the brain and potentially block t-PA’s negative effects that lead to bleeding in the brain. Neucardin can possibly be deliver in an ambulatory setting due to its relatively safe profile. It can be given to the patient even before it has been determined if a stroke took place.