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in six of 12 patients with blood cancers like chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. They got a variety of low doses in an early stage trial. This sort of dose-escalation study, in which researchers tend to start low and ratchet up doses gradually, is supposed to give companies a sense of whether the drug is safe, and isn’t really designed to show tumor shrinkage.
The first patient who enrolled in the study at Sarah Cannon Cancer Center in Nashville, TN, who got the lowest possible dose, showed tumor shrinkage. The researcher there, Ian Flinn, said in a company statement that he was “surprised and pleased” to see a tumor response at such a low dose. The drug was generally well-tolerated, and researchers didn’t reach the maximum dose patients could tolerate.
The next step will be to enroll 60 patients in the study, at a dose that’s more likely to be effective, Stocks says. The company hopes to have some results from this deeper look at the drug in time for the American Society of Hematology meeting in December, a big showcase for blood cancer drugs.
The next really big test for Calistoga will be whether it, too, can sign a big partnership. Calistoga has a full slate of meetings scheduled with prospective partners at the ASCO meeting, Stocks says, and he’d like to do a deal in late 2009 or early 2010.
When I asked if the price for CAL-101 just went up because of the precedent set by Exelixis, he said this: “It supports the benchmarking we’ve already done, and the valuation we’re run on the asset and the company.”