Two-drug combo may improve traumatic brain injury therapy – The San Diego Union-Tribune

Traumatic brain injury is in great need of better therapies. Its victims are often young, including athletes and those in the military.

Bruce Chandler May, a physician from Santa Barbara, says he has found such a therapy. Hes the president and CEO of a company thats developing the therapy, Inflammatory Response Research, Inc. Mays in San Diego for the BIO International biotechnology convention to meet potential partners in government and private industry.

I ran into May by serendipity Sunday evening when we were were both passengers on a Lyft ride. Heres his story in question and answer format.

Q: How did you make this discovery?

A: I practice trauma medicine at Santa Barbara Cottage Hospital, and I discovered synergy between two existing molecules, levocetirizine, which is the top antihistamine in the world, and montelukast, an asthma drug which is the top leukotriene modulator in the world.

We plan to combine the two molecules as a First Response injectable for the military. It will be the first new therapeutic in over 30 years, a safe and effective treatment for traumatic brain injury and blast injury.

Q What stage of development is this in?

A: We have established proof of concept for multiple diseases. The next stage is to manufacture the compound in various forms, initially as a lyophilized powder (freeze-dried) or autoinjector delivery system for the military. Inflammatory Response Research, Inc. presently has 8 issued patents in five countries, with recent notice of allowance for traumatic brain injury in Europe.

Q: How precisely did you discover this synergy between the molecules?

A: My background is in engineering, medicine and law. I currently work in a trauma and respiratory disease setting at Santa Barbara Cottage Hospital. During the throes of H1N1, the flu pandemic, we found physicians were treating influenza with TamiFlu, which simply prevents the preformed vial particle from exiting the cell. No one was addressing inflammation created by the virus. Subsequently uncovered was the remarkable synergy between levocetirizine and montelukast to treat a myriad of disease states.

I realized that the mechanism could treat traumatic brain injury and trauma.

Q: And with whom will you be discussing this discovery at the convention?

A: Weve been in contact with the Department of Defense and the FDA. The company has scheduled meetings with several large pharmaceutical companies and the National Institutes of Health to move the project forward

Q: How does this therapeutic help TBI cases?

A: Levocetirizine is an ideal molecule in a test tube. It decreases inflammation in the brain and other organs.. Montelukast blocks leukotriene D4 at the cell level. Leukotrienes are similar to histamine, but 100 to 1,000 times more potent in the lung than a similar weight of histamine. In addition to the intrinsic, i.e., basic mechanisms of action of levocetirizine and montelukast, there is synergy at multiple target within the immune system.

Q: Have you tested this in animal models?

A: Weve used the combination to treat both outpatients and inpatients since 2008.

Q: What are your expectations?

A: Were extremely excited about the prospect of making this therapeutic available not only for military applications such as blast injury, but for sports-related injuries, motor vehicle accidents and other forms of major trauma.

Q: Why are you attending the BIO convention to discuss this therapeutic?

A: Its a beautiful convention to meet a cross-section of very profoundly interesting, educated and informed people in the biotech industry. And I love coming every year to BIO International because of the wonderful cross-section. Whether its your own product or someone elses, you always learn something.

bradley.fikes@sduniontribune.com

(619) 293-1020

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Two-drug combo may improve traumatic brain injury therapy - The San Diego Union-Tribune