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to hire more staff right away, Gallagher says.
Calistoga’s lead product these days is called CAL-101. The company has completed a Phase I clinical trial that looked at multiple doses of the product in a dozen patients, and data from the study will be presented in a few weeks at the American Society of Clinical Oncology meeting, Gallagher says. The trial will expand to four more groups of a dozen patients each: people who have chronic lymphocytic leukemia, slow-growing non-Hodgkin’s lymphoma (NHL), aggressive NHL, and acute myeloid leukemia. The first look at data on safety and initial indicators of effectiveness ought to be ready by December, at the meeting of the American Society of Hematology, Gallagher says.
The company’s second program is now going by the name of CAL-263. This is a different compound made to block the same PI3 kinase delta isoform, albeit in a way that could be useful for chronic inflammatory diseases, specifically asthma and rheumatoid arthritis, Gallagher says. This product should be ready to advance into Phase II trials for both asthma and rheumatoid arthritis—a pair of potentially big markets—in early 2010, she says.
The newest compound working through the Calistoga pipeline is CAL-120. This drug is made a bit differently, to block both delta and another flavor of PI3 kinase known as beta. That means it should work better against a range of solid tumors, not just blood cancers, Gallagher says. It also allows Calistoga to remain differentiated from competitors, who have pan-PI3 blockers that hit a third variety of this popular pathway, that goes by the name alpha. Calistoga has stayed away from that variation because it sees potential for such a drug to disrupt sugar metabolism and insulin sensitivity, which might bring unacceptable side effects, Gallagher says. CAL-120 ought to be in clinical trials in 2010, she says.
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