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saw increases in liver enzymes, which came down after therapy was halted and re-initiated at a lower dose. Four of the first five patients with indolent non-Hodgkin’s lymphoma who got the new Calistoga drug in combination with rituximab had their tumors shrink by half, researchers said.
“The preliminary results from this trial suggest that CAL-101 can be safely combined with current standard-of-care therapies and may provide more improved and durable responses, without added toxicity, for patients with relapsed and refractory indolent NHL or CLL,” said Ian Flinn, a researcher at Sarah Cannon Cancer Center in Nashville, TN, in a statement from Calistoga.
Encouraging as it all seems, every shred of the evidence has to be filed under the header of exploratory or hypothesis generating. It’s not strong enough for the company to bundle up and ship off to the FDA for review. That’s what comes next.
Calistoga is in the midst of developing the protocol for a pivotal study that it hopes will form the basis for FDA approval of CAL-101, Gallagher says. The trial will put together a network of 35 to 40 sites in the U.S. and Europe, and will enroll a total of 100 patients with indolent non-Hodgkin’s lymphoma, she says. The plan is to start enrolling patients later this month, or early in 2011. By the end of 2012, Calistoga hopes to have generated data to show that it can reach its primary goal of tumor shrinkage and receive FDA approval by the end of 2013, Gallagher says.
While that study is going on, Calistoga is working up the protocol for a similar pivotal study in chronic lymphocytic leukemia patients. Calistoga has met with the FDA and sought its advice on proper study design, and it has examined the regulatory pathway that competitors have followed before. The company hasn’t sought a written agreement from the FDA on the study design—what’s known as a Special Protocol Assessment—because that could take six months or more, and the company is racing to stay ahead of competitors, Gallagher says.
“We don’t want to slow down and let them catch up,” Gallagher says. “We think we’re about three to four years ahead.”
That’s the scuttlebutt she’s been hearing at the ASH meeting, referring to a number of Big Pharma companies developing PI3 kinase inhibitors that are specifically tailored to the delta isoform, like Calistoga’s lead product. All of the Big Pharma contenders in that class are still thought to be in animal studies, Gallagher says. Other PI3 kinase inhibitors in clinical trials tend to be more broad-reaching against a number of isoforms, and aren’t really direct competitors, she says.
Besides the data presentations, lots of other stuff, of course, happens behind the scenes at medical meetings like ASH. Gallagher says she was happy to see during one of the medical education sessions that thought leaders spoke openly about CAL-101 as one of the important future agents to watch. “We’re seeing broader awareness, and that’s good,” she says.
Calistoga has also been talking with investigators who are showing interest in participating in its next clinical trials, in order to get access to the drug for their patients, Gallagher says. And Big Pharma’s dealmakers are there, still holding meetings with Calistoga. Gallagher wouldn’t say if she plans to bring on a partner to help take CAL-101 all the way through the FDA approval process. With the recent hiring of new R&D head Langdon Miller and finance chief Andrew Guggenhime, Calistoga has the people in-house to go it alone, she says.
“We haven’t decided yet if we’ll go further along with our assets being wholly owned, or whether we’ll get help,” Gallagher says. “We are well prepared to go our own way if that’s what we decide to do. We have the team now in place.”
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