In an effort to find an additional treatment that may protect against some of these effects, scientists from The Scripps Research Institute (TSRI) in La Jolla, CA, have developed a new drug called 3K3A-APC.
The drug is an engineered variant of activated protein C, which humans normally produce. It has been linked to the regulation of blood clotting and to certain aspects of the body's inflammatory response.
This new clinical trial was placebo-controlled, meaning that the drug's actual efficacy was tested against a placebo. It also set out to confirm how high a dose of the experimental drug would be safe for human participants.
Therefore, the scientists recruited 110 people who had had acute ischemic stroke and who were following treatment with tPA, intra-arterial thrombectomy, or both of these therapies.
The participants — all aged between 18 and 90 — were followed for a period of 90 days, as they were administered varying doses of the experimental drug.
The scientists experimented with four different dosages — 120, 240, 360, and 540 micrograms per kilogram. All four dose levels — including the highest one — were tolerated well by the subjects, so the researchers declared them safe for human use.
Also, the drug was seen to perform well in terms of results related to intracranial hemorrhage, or brain hemorrhage.
It was found that the drug helped to reduce both total hemorrhage volume, or how much blood "leaked," and hemorrhage incidence, or how often the participants experienced this event, significantly.
"The observed trend toward lower hemorrhage rates is consistent with our expectations based on the drug's mechanism of action and activity in animal studies," says Dr. Patrick Lyden, one of the researchers involved with the current clinical trial.
But he adds that "[t]hese results should be confirmed in a larger clinical trial." This, the researchers explain, will be their next step. They aim to eventually get FDA approval for the experimental drug.
