Merck’s New Cancer Drug Dead in the Water

Drug maker Merck and Co. said today its proposed new heart failure drug has failed a key clinical trial and the company will not seek Food and Drug Administration in 2009 as planned.

The drug, rolofylline, failed in the trial to improve patient symptoms when compared to a placebo, officials said.

In the PROTECT late-stage trial, 30-mg doses of rolofylline did not lower the risks of death or hospitalization for heart and kidney complications within two months of taking the drug. The drug also did not reduce kidney impairment, the study found.

Full results of the PROTECT trial, which studied more than 2,000 patients, are still being reviewed by Merck and will be released later this year, officials said. The company called the preliminary results of the poor showing in the clinical trial “disappointing.”

Merck had billed rolofylline as a possible new treatment for acute heart failure, a condition for which there are few proven and effective treatments. The company had planned to ask the FDA to approve the drug sometime in 2009.

The FDA is the federal agency responsible for review drug-company applications for new drugs and determining whether the products are safe and effective. Dangerous prescription and over-the-counter drugs account for thousands of patient deaths, injuries, and adverse reactions in the United States each year.

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