Oncothyreon CEO on Next-Generation Cancer Vaccines, Two Key Zymonites, and Serious Luck

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where it went into a pivotal trial and didn’t work, but it did in a subgroup?

BK: It wasn’t a pivotal trial. It was a randomized Phase II trial which enrolled patients with both Stage IIIb and Stage IV non-small cell lung cancer. It is true that in the overall trial, there was a little over a 4-month survival advantage for the Stimuvax group which wasn’t statistically significant. It’s also true that in the pre-stratified group of Stage IIIb patients, there was a 17-month survival advantage. That wasn’t a pre-specified endpoint of the trial, but the group was stratified in advance. The randomization for that worked. You’re right, it was an exploratory analysis of a Phase II trial, but there wasn’t a lot of data mining required to get to that result.

X: That’s what gave rise to the START trial, right?

BK: Yes, those are the data that led our partner, Merck KGaA, to initiate the START trial. It’s designed to look at just patients with Stage III disease.

X: When do you expect data on that one?

BK: Merck has said all along that the trial would conclude sometime in 2011. There are two interim looks in that trial. The first of which occurs when 50 percent of the expected deaths in the trial have occurred. It’s really hard to predict exactly when that’s likely to occur. If the trial’s going to end in 2011, a reasonable guess would be that has to happen sometime before the end of 2010. It’s likely we’ll get the first interim look at that trial sometime before the end of next year.

X: And in parallel, they also have a pivotal trial going on for patients with breast cancer, and for lung cancer patients in Asia, right?

BK: There are two other Phase III trials now ongoing. There is the Asian lung cancer trial that just started, called INSPIRE, and then there’s a trial in breast cancer that’s being given to patients with hormonally sensitive, advanced breast cancer. So it’s patients with metastatic or recurrent disease that would normally be treated with hormonal therapy like tamoxifen or an aromatase inhibitor. They’ll get the hormonal therapy, plus or minus Stimuvax. That trial started a few months ago.

X: I’d like to take a step back again. You raised a lot of money, $24 million, you’ve got more resources. Can you help me understand how you and the board are thinking about where … Next Page »

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