you’re going to take this in the year ahead now that you have more options? I didn’t think you were going to survive a year ago.
BK: The ability to raise some money this year has clearly put us in a stronger position than we were a year ago. The combination of the restructuring we did in December, selling the Edmonton facility to Merck KGaA, and then raising $24 million in cash above and beyond what we got from the Merck KGaA deal (about $13 million), really puts us in a position where we can get some of these important milestones without necessarily having to do additional fundraising.
We’re going to get data from Stimuvax as soon as the end of 2010 and on into 2011. We can get to those data points without really having to worry about it. You’re right, a year ago that was absolutely not a true statement. I think that’s reflected now in how people view us. They recognize we can do that now.
We’re going to take our resources, and we’re not going to spend so much that we can’t get to our milestones, but we are actively going to do some development. One of those things, which we’ve been talking about, is going ahead with BGLP40. The strategic thinking is clear that if Stimuvax succeeds, this will be a very valuable property. It will take a relatively small investment to create that value. We will be spending 2010 finishing the preclinical development of that so that we can go into the clinic with it in 2011.
We’re also going to be actively going forward with our small molecules. This is already public, but we’ve made a commitment that we’re going to take PX-866, our PI3 kinase inhibitor, into Phase II in 2010. We expect to start at least two Phase II trials of that drug by the end of 2010. We haven’t yet discussed what those trials will be. But that will be the major focus of our activity in 2010. The PI3 kinase is clearly a hot topic in oncology. We think we have an interesting and unique compound in that field. PX-866 is the only irreversible inhibitor of the PI3 kinase that we’re aware of in clinical trials. We think that will give the molecule a significant pharmacodynamic and pharmacokinetic advantage over the competition.
X: I remember you have talked about doing a partnership with that drug before. Why not do that this year? Was it a matter of actually having resources to develop it yourself?
BK: What we always wanted to do was take one of our two actively developed small molecules into Phase II and to partner. If we were going to have two in Phase II, we’d have to partner to do that. I’m committed to the notion that if you’re going to take a molecule into Phase II, you had better run a pretty broad Phase II development program and really learn how to use your molecule. That’s what Phase II is all about. You can’t do that in a single Phase II trial. We can’t meet our strategic goal of having sufficient resources to get to the Stimuvax endpoint AND do adequate Phase II development programs for two small molecules with existing resources. That just doesn’t work.
One solution to that is if you do have two to go into Phase II, and you partner one or the other. We never said which one it would be.
X: So what about the HIF-1 alpha drug, your other small molecule?
BK: We haven’t finished Phase I. And we haven’t made a decision about it. That’s exactly my point. If it turns out at the end of Phase I trial, that we need to go ahead with another trial, then we’ll partner
