An old intravenous antibiotic may have new life as a stroke treatment, according to a team of researchers from the Medical College of Georgia and the University of Georgia.
The researchers are studying minocycline, a broad spectrum antibiotic, in a $1.8 million clinical trial funded by the National Institute of Neurological Disorders and Stroke.
Dr. David Hess, chair of the MCG department of neurology, is the trial’s principal investigator. Susan C. Fagan, UGA professor of pharmacy, is co-principal investigator. The researchers said the drug appears to reduce stroke damage by inhibiting white blood cells and enzymes that, at least acutely, can destroy brain tissue and blood vessels.
They said it also seems to reduce cell suicide in the minutes and hours following a stroke, enabling more cells to recover. The team will study the drug in 60 stroke patients in Georgia, Kentucky and Oregon.
“We know it’s safe in humans and we know the concentrations we need to see improvement in the brains of rats can be achieved safely in humans,” said Fagan, who is also assistant dean for the MCG program of the UGA College of Pharmacy. “That’s an important consideration.”
Their animal studies have shown the drug, given within six hours of a stroke and then every 12 hours for up to three days-the peak time of inflammation-reduces stroke damage by up to 40 percent. In humans, the researchers said they believe the antibiotic will be an effective adjunct therapy for tPA, the only FDA-approved drug therapy for strokes.
“It’s a safe drug that is easy to give and tolerate, that gets into the brain well, and may reduce bleeding, the primary side effect of tPA,” Hess said. “We think it will make strokes smaller and patient outcomes better.”
The drug’s safety and optimal stroke dose are the primary focus of the phase-one clinical trial in stroke patients who arrive at MCG, the University of Kentucky or Oregon Health and Science University within six hours of symptom onset and with measurable neurological symptoms.
The researchers will fine-tune the dose by looking in the blood for biomarkers, indicators of inflammation, to see if inflammatory factors go up after three days.