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Because the safety profile of its lead compound, CAL-101, was so mild in animal tests, Calistoga was able to perform its first clinical trial in healthy volunteers back in March. “That’s unusual for a cancer drug,” Gallagher says, because usually they are too toxic to be given to healthy people just to measure things like how well it distributes in the body, how long it lasts, and what side effects it causes. The data showed no serious side effects, Gallatin says.
That body of evidence helps Calistoga with its early clinical trial strategy, because its first test in actual cancer patients can now use doses that are in the ballpark for actual therapeutic use, instead of the usual start-low-go-slow dose escalation approach, which can discourage doctors from enrolling patients quickly in a trial, Gallatin says.
Even so, getting the data will take time. Calistoga expects to have results from a 60-patient Phase I study of its lead drug candidate, CAL-101, in mid-to-late 2009, Gallagher says. The company expects to take a second prospect into a trial of healthy volunteers before the end of this year, which may have better properties for inflammatory diseases like asthma or rheumatoid arthritis, in which drugs need to be given chronically, sometimes for years, she says.
Gallagher says she enjoys digging into the science of the company, and that she was attracted to work with a management team full of people who have the experience of taking a drug through trials all the way to the market. As opposed to other marketing types she’s worked with, who are cautious about anything other than me-too products, she says she relishes the risk of navigating clinical trials with a drug that’s first in its class. Her main job will be to think strategically about finding the right patient population, the right partner to co-develop the drug, and strategies to make sure that doctors will be motivated to use it.
Gallagher sure sounded fired up about the job, and Seattle, during our conversation. “It’s wonderful,” she says with a laugh, while looking out her 19th floor window at the Space Needle and Queen Anne Hill, on a sunny fall afternoon. “My husband and I are sailors, and there’s plenty of water here. The nature here is breathtaking.”