Question-and-Answer Session
Operator
Thank you. (Operator Instructions) Your first question comes from the line of Mark Monane with Needham & Company. Please proceed.
Mark Monane - Needham & Company
Good morning and greetings from New York City. Thanks for taking our questions.
Paolo Pucci
Good morning.
Mark Monane - Needham & Company
It's a little cloudy here, which is reminiscent of my question I'm going to ask regarding dose response and maximum tolerated dose. You mentioned that 300 milligrams twice a day is the maximum tolerated dose, but is that necessarily the most effective dose? I know you have information from the Royal Marsden study. Is more better in this situation?
Brian Schwartz
Mark, this is Brian Schwartz responding. In terms of determining the recommended dose moving forward, we are using a number of criteria that have been generated primarily out of the Marsden. The one that has emerged is that above a 100-milligram twice daily dosing, we get significant inhibition of our target, which is c-Met. Therefore also, we have seen that our pharmacokinetic profile is within the higher range, will give every patient the opportunity to get a significant amount of the drug, which would then potentially inhibit the target.
In terms of efficacy, that's the real test of the Phase II studies moving down the line, but it appears that if c-Met is an important target that the doses we'll be giving at 300-milligrams will be able to inhibit their target successfully in a majority of patients where their target is regulated.
Mark Monane - Needham & Company
How much inhibition are you looking for? Is it a step function where you get, you don't get a clinical or physiological effect until you get a certain level, or is it more like a linear response?
Paolo Pucci
I think this is a question is best answered by Tom Chan, who has been working with a product that (inaudible) he should have the informed answer.
Tom Chan
Good morning, Mark. Tom Chan here. I think the typical inhibition that we've been seeing so far, the Royal Marsden study were basically 66% to 75% inhibition of the tumor c-Met expression and that's kind of what we can expect going forward.
Mark Monane - Needham & Company
Okay, very helpful. And in regard to the time line, are you going to dose escalate the current patients, or are you going to enroll new patients and how does it affect the time line for the MIT and for the pancreatic cancer studies, please?
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