by Jon W. Sparks
innovation: TS23, an antibody that inhibits the molecule regulating clot dissolution as a better therapy to dissolve thrombi, which cause strokes and acute cardiovascular disease.
Few things are as difficult for a doctor as being unable to save a patient.
“That was one of the most profound things that happened to me in my training,” says Dr. Guy Reed, a cardiologist, the Lemuel Diggs Professor of Medicine, and Chair of the Department of Medicine in the College of Medicine at the University of Tennessee Health Science Center. “A patient came in and developed weakness on one side of the body, an indication of a stroke. We gave the best care we could at the time, but he died within 24 hours.”
Reed knew there wasn’t enough understanding of the causes of ischemic stroke and that there wasn’t a safe enough treatment for it. But rather than staying frustrated, he got to work looking for a solution.
For several years now, he’s been looking for a better therapy to dissolve blood clots, which cause most strokes. The result is TS23, a blood clot dissolving agent undergoing clinical trials and which holds the promise of providing vastly improved treatment of stroke and acute cardiovascular disease for millions of patients.
His research sought to determine what it is that regulates clot dissolution. The research team found a promising molecule and created an antibody that would inhibit the molecule, resulting in blood clots being dissolved. Further research was done to ascertain if it could be used in humans and, thus far, the results are encouraging enough that he’s received funding support from the National Heart, Lung, and Blood Institute of the National Institutes of Health and the National Institute Of Neurological Disorders and Stroke. Last year, a licensing agreement was made with an international firm and the therapy is expected to be submitted to the Food and Drug Administration in 2020.
While there are other studies being done on treatment of stroke, “this is the only research targeting this molecule in the country,” Reed says.
Reed came to UTHSC in 2008 from the Medical College of Georgia in Augusta, where he was the Kupperman Professor of Medicine, the chief of cardiovascular medicine, and co-director of the Georgia Cardiovascular Center of Excellence.
Taking over the leadership position at UTHSC was a significant career move for Reed, giving him strong academic opportunities in a department that has 11 divisions, encompasses about 400 faculty, and more than 200 residents and fellows, as well as providing clinical training for the medical students.
But there was much more than that. “I give credit to UT because it has created an environment that encouraged moving scientific insights into products to benefit people,” he says.
An area where UTHSC has taken the lead is in stroke research since the Mid-South is smack in the middle of America’s Stroke Belt. “One of the reasons we were inspired to come here is stroke is a particular problem in the southeast United States and in Memphis where the incidence of stroke is highest in the country and the death rate from stroke is the highest,” Reed says. “We felt this was the place where there is a focus on addressing the disparity and the scientific interest and community would be supporting.”
One of the innovations UTHSC has undertaken is creation of a Mobile Stroke Unit, a sophisticated ambulance with advanced CT capabilities that can save precious minutes in getting treatment for patients. It’s an effort to shorten the time it takes to get a patient treatment since the longer a stroke goes untreated, the worse the situation is likely to become. If a stroke patient can be treated quickly with tissue plasminogen activator (tPA), then the prognosis improves.
But the problem with tPA is that it’s limited. It has to be given quickly and can cause major bleeding. “The longer a patient has stroke symptoms, the more the benefits of tPA decline and its harmful effects increase,” Reed says. “It’s a competing risk-benefit ratio, and ends up being used in only 5 percent or less of the patients who have ischemic stroke.”
Testing thus far indicates that Reed’s clot dissolving agent addresses those issues and thus could dramatically increase the survival rate of stroke patients.
Last year, Reed’s research company — Translational Sciences, Inc. — signed an exclusive licensing agreement with Tokyo-based Daiichi Sankyo Co. to develop and commercialize TS23. Reed, who is CEO and Chief Science Officer of Translational Sciences, says the trials and the research and development process take considerable time and money. “We looked for partners experienced in doing these kinds of studies and doing them well.”
After some two and a half years and scores of meetings, phase one of the trial was done and the licensing agreement with Daiichi Sankyo was signed. The Japanese company, which has among its interests development of treatments for thrombotic disorders, will take up phases two and three beginning next year.
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