Discovery Scientists Receive NIH Funding for Spinal Cord Injury Therapy

A group of Miller School scientists has received a $1.6 million small business award from the National Institute of Neurological Disorders and Stroke, a unit of the National Institutes of Health, to support development and clinical trials of a novel anti-inflammatory antibody treatment for human spinal cord injury.

Robert W. Keane, Ph.D., professor of physiology and biophysics, leads the team, which includes three researchers from The Miami Project to Cure Paralysis — Helen M. Bramlett, Ph.D., associate professor of neurological surgery; Juan Pablo de Rivero Vaccari, Ph.D., research assistant professor of neurological surgery; and W. Dalton Dietrich, Ph.D., Scientific Director, Kinetic Concepts Distinguished Chair in Neurosurgery, Senior Associate Dean for Discovery Science and professor of neurological surgery, neurology, and cell biology and anatomy.

The therapy is delivered in the form of an antibody that targets and neutralizes the inflammation that is the innate immune response to injury, and which is believed to represent a clinically relevant secondary insult. The antibody has been shown to be effective in several experimental neurological conditions, including spinal cord injury (SCI), stroke and traumatic brain injury.

“This overall approach is novel in that it targets inflammasome activation in brain cells and reduces the production of potentially toxic factors that can lead to secondary cell death and subsequent functional deficits,” said Keane. “Because there are no current FDA-approved therapies to treat SCI, this new therapeutic approach may hold great promise for the thousands of individuals who sustain an SCI each year.”

The scientists formed a company, InflamaCORE LLC, in 2009 to commercialize their discoveries. On December 3, 2013, it received a U.S. patent entitled “Modulating Inflammasome Activity and Inflammation in the Central Nervous System.” The company, with UM as collaborator and subcontractor, then submitted a Small Business Technology Transfer (STTR) Program application for the funding.

“The University wants to foster interaction with start-up companies and spur innovation,” said Keane. “We’re proud to collaborate in its first STTR application. This critical funding from NIH will allow for the humanization of the antibody and subsequent testing in a translational model of SCI.”

Norma Kenyon, Ph.D., the School’s Chief Innovation Officer and the University’s Vice Provost for Innovation, said, “The U Innovation team is very enthusiastic about and highly supportive of the efforts of Dr. Keane and his collaborators. We are excited about the science, as well as the therapeutic and commercial potential of the antibodies. The success of Dr. Keane and his colleagues demonstrates the real potential for obtaining funding to pursue translation of basic science discoveries.”

Based on the safety and toxicity findings obtained with the humanized antibody, an Investigational New Drug application will be submitted to the FDA for permission to begin human clinical trials.

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