CTIC @ UBS
For some reason CTIC had Steve Aselage presenting. Maybe because Aselage is able to talk so much faster than Bianco and there was a lot of mileage the company wanted to cover during the presentation. What a difference compared to the Withys and Ringos of this world.
The subject of most interest was of course information on how the Stellar 3 trial proceeds. According to Aselage 218 events (i.e. deaths) had been reached "in August" and there was 240 events as at September 15. The trial plan foresees that the study will be unblinded when the 311-events point has been reached. The company hopes to be able to present data from the trial early 2005, to file the IND mid 2005 and - with the support of a priority review - have the product approved towards the end of 2005. Provided the trial meets its endpoint, of course. It is really a very aggressive trial design. They are going head-to-head against the standard of care with medium survival as endpoint. And with a fairly large trial size.
He also gave some comments with regard to dosing. Historically PS 2 patients have - due to their general poor condition - in "similar" trials received less than 3 doses of the standard docetaxel/carboplatin regimen. In Stellar 3, 42 % of the patients have received 5 or even 6 doses and the average for the patients is around 4. (Which would of course fit nicely with the control arm receiving the standard slightly less than 3 and the Xyotax arm somewhere between 5 and 6. But that is just my own calculation, he didn't say that. We have also the question whether the ability to receive more doses can be considered as a good indicator for an increase in the length of survival).
The GOG Xyotax ovarian cancer trial takes longer to get started than what the company had expected. There was no explanation given as to what the problems were, just a hope being expressed that they would get underway before the end of the (this) year.
I am continuing to be impressed by the historical data seen so far with Pixantrone. The company is busy recruiting patients for the pivotal trial in aggressive NHL with a target of 160 patients (It used to be 320?). There is an interim look foreseen (maybe that is where the 160 comes from) in the study's protocol and if positive CTIC hopes to be able to file an IND towards the end of next year. The primary end point according to the SPA is confirmed plus unconfirmed (!) CRs, which are normally not seen at all in this patient population. The patients in the control arm may be treated with "whatever the oncologist feels suitable." A very flexible choice depending on the fact, that for these very advanced patients there is very little, if anything, that works. In a previous similar smaller phase II study there was a 20 % CR-rate for patients treated with Pixantrone as a single agent.
CT-2106. There was something here that I didn't quite catch. Evidently the dose-limiting GI toxicities from "normal campthotecins" have not at all (or to a very small degree) been seen with CT-2106.
Finally, he noted that data from the preclinical proteasome inhibitor(s) and platinum products continue to look good and that they are advancing towards their respective INDs. The proteasome inhibitor does actually belong to Cephalon, which company farmed out the preclinical work to NovusPharma (which he of course didn't mention).
Erik |
