The MP-470 phase 1 (single agent) trial did not demonstrate consistent PK/PD. This means that as the drug dose when up, the blood levels did not consistently rise. The PK/PD curves have been in our last two MP-470 poster presentations. This may or may not be important to our future development of MP-470 because the 1b study of MP-470 (use in combination) is escalating doses of MP-470 and demonstrating signs of activity at the lowest levels. We have highlighted a few of these patients in our presentations. As a result, we are continuing our phase 1b trial while we develop a new formulation that might be able to deliver consistently higher levels of drug and explore the effects of our drug, on patients, close to a maximally tolerated dose (MTD). Because of this dual track, we are not sure how far this might push out our phase 2. The original milestone was to start a phase2 trial this year. That milestone will go out until at least mid 2009.
Timothy L. Enns
SVP Corporate Communication & Business Development
"Because of this dual track, we are not sure how far this might push out our phase 2. The original milestone was to start a phase2 trial this year. That milestone will go out until at least mid 2009."
Billy, has Supergen management stated that it will delay the phase 2 in any of its public announcements or investor presentations before you received this from Tim Enns? Do you think that a delay of the MP470 phase 2 is a material development that should be disclosed in a more comprehensive manner?
This is the second drug where formulation has become a limiting issue for achievement of milestones. I believe it has also delayed S110 for at least a half a year. The company has not updated any report on progress of S110 formulation. Does the climb algorithim not take drug solubility and potential serum level into account. For MP470 Is this an availability problem or a metabolism problem?
No, they have not released this to the public, however they did mention the reformulation, so I guess we're to put the piece's together. Mp-470 was not a Climb drug and neither was S110. I have not heard of any reformulation issue's with S110. We'll have to see how they explain the problem in a few weeks at the next quarters update.
Pk/PD is used to measure how much of the drug is in the blood. If you increase the mg, you would expect a increase of the drug in the blood stream. But they're not seeing that as a single agent. It means that the body only absorbs some of the drug. They had one response as a single agent and several in combination. On Oct 21-24, supg will present data at Eortc-Nci cancer conference from the ph1b.
Combination seems to be the best direction, mp-470 inhibits several pathways and with the low tox, is a perfect combination drug.