Calistoga Builds More Momentum for Cancer Drug, Eyes Pivotal Trial Next Year

12/8/09Follow @xconomy

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of the drug was infection, but researchers saw a “low incidence” of white blood cell and red blood depletion that is common with many chemotherapies, and which makes people feel anemic and vulnerable to infection. That means that the Calistoga drug is likely to be combined with existing treatments, because researchers won’t be so worried about exacerbating that side effect, Gallagher says.

The data being reported at the ASH conference is current as of late October, but more updated data could be available soon. Calistoga has now completed enrollment of all 90 patients in the study, and expects to have one-month evaluations completed on all of them before the end of the year, Gallagher says.

A lot of important questions still need to be answered before Calistoga decides on its next move in larger, more rigorous clinical trials. It wants to see the full data set before it picks an ideal dose for the next round of studies. Many patients got 200 or 350 milligram doses, which caused some patients to have elevated concentrations of liver enzymes in the blood, which can be a sign of liver damage. That effect was reversible when patients quit taking the high doses, and patients have been able to resume taking lower doses later on, Gallagher says.

That’s not too much of a concern, Gallagher says, because this early dose-ranging study of CAL-101 showed that it was able to cause partial tumor shrinkage at doses as low as 50 or 100 milligrams. “We saw activity at all dose levels,” she says.

Some anecdotal reports have been making the rounds during conversations in New Orleans, she says. One was about a female patient who had a lymph node that had enlarged so much that she was having trouble breathing, but within 28 days of taking CAL-101, it shrank by half and enabled the patient to breathe better, Gallagher says. Another patient, a chemistry professor, was getting hospice care, but was able to get back to teaching after taking the drug, she says.

One of the next big steps for Calistoga will be whether it can find a partner to help pay the expensive bills of running pivotal clinical trials. Back in March, the company hired a proven dealmaker in Cliff Stocks, formerly of Icos, as its chief business officer to do just that. Gallagher had nothing specific to say about partnering other than that “we have a lot of interest” at the ASH meeting. She noted that the company is also looking for a partner to help it develop other drugs in its pipeline besides CAL-101, as it branches into treatments for autoimmune diseases and solid tumors.

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