Novel drug-antidote strategy provides greater control of drug action

e Clinical Research Institute. "We can't easily stop or reverse the action of these drugs quickly. If this new approach works out, it should give us much greater control in so many situations where a drug is long-lasting but has potential side effects."

The researchers took the challenge, and decided to create a drug-antidote pair from scratch. Their target was human coagulation factor IXa, a pivotal clotting factor in the complex cascade of biochemical events that ultimately leads to the formation of a blood clot. Past studies have shown an association between elevated levels of factor IXa and the onset of acute coronary syndrome.

The researchers discovered anticoagulant aptamers that target factor IXa. Aptamers are single-stranded nucleic acids (RNA or DNA) that bind to specific protein targets with high affinity and specificity. The first drug from this new class of therapeutics, Eyetech's Macugen, recently demonstrated high efficacy for the treatment of age-related macular degeneration in Phase III clinical trials.

"As soon as the drug is developed, the antidote comes relatively easily," Sullenger said. "Once we determined the identity of our drug, we were able to design an antidote that would bind to the drug at a specific site, causing a conformational change, which rapidly and durably neutralizes the activity of the drug."

The Duke researchers previously described the discovery and design of this anti-factor IXa aptamer-antidote pair and demonstrated the blood-thinning activity of the drug and the neutralization activity of the antidote in the test tube in a paper published in Nature (Sept. 5, 2002).

In their current experiments, the researchers first demonstrated that the factor IXa inhibitor was an effective anticoagulant in pigs. Then, once the blood was anticoagulated, they injected the antidote into the treated pigs.

"The antidote neutralized more than 95 percent

Contact: Richard Merritt
Duke University Medical Center

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