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last month in Howard Pien, who was CEO of Medarex before that company was acquired last year by Bristol-Myers Squibb for $2.1 billion.
Interestingly, the Ikaria prospectus doesn’t really say much about the prospects for IK-1001. But it is thought to act as an anti-oxidant or an anti-inflammatory drug. “While the reasons for these biologic effects are not completely understood, they have been demonstrated in several animal models,” Ikaria said.in the filing
Given what the company has seen in animal tests, Ikaria is looking at IK-1001 for single-use emergency medicine situations in which people are suffering tissue ischemia, like when blood is cut off to an organ, as in a stroke. The drug might be useful in a number of ways, including heart bypass surgery or diabetic ulcers. The lead indication is to prevent tissue damage that occurs when blood flow is restored following a heart attack, the company said.
It sounds like the concept for the drug is still very much a work in progress, at least based on the filing. About 170 patients have enrolled in three separate clinical trials, with about 80 percent of them on the drug and the rest on placebo. Ikaria has tried a fast one-minute IV dose, and more steady doses for as long as six hours. Most adverse events in the trials were mild-to-moderate and resolved themselves, the company said. Ikaria started a mid-stage clinical trial of the drug for coronary artery bypass surgery, but cancelled the study when it decided it needed a “rapid and reliable assay methodology for IK-1001.” The company plans to re-start the trial to get some data on effectiveness once it has developed the assay.
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