Biotech company Medarex (MEDX) and partner Bristol-Myers Squibb (NYSE:BMY) announced Monday that one of three studies evaluating the cancer drug ipilimumab as a secondary treatment for melanoma failed to meet its primary endpoint. Medarex shares plummeted 19.5% to $10.75 in AH trading. The missed endpoint was to rule out a "best objective response rate of less than 10%," meaning the total or partial shrinking of tumors in at least 10% of the trial's subjects. Overall, the three trials indicated "a clear dose response effect" and objective response rates in the "mid-single digit to mid-teen range." The three trials involved 487 patients with advanced stage III or stage IV metastatic melanoma at centers around the world. Medarex and Bristol-Myers said the results were consistent with those of earlier studies. They are meeting with the FDA soon and plan to file for regulatory approval in H1 2008.
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