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mcbio

04/06/13 12:18 AM

#159400 RE: BTH #159397

What do you take this to mean? "AEs consistent with target suppression". The Cohort1 is at 30mgs, Cohort2 at 60mgs. Should they have already seen AEs at the lowest dose level? I suppose if fhe drug is showing efficacy, and is doing its job, ok....but? And I am sure you know, 2 of the 3 patients in Cohort1 are multiple myeloma patients, refractory to two or more prior tx.

Well, the CEO said they saw the AEs in the lowest dose cohort and now they are expanding into a second cohort (higher dose) so I take it that the drug is doing what they had hoped and not that these are unexpected AEs. If the AEs were not anticipated and a showstopper, they presumably wouldn't be expanding into the second cohort at a higher dose. Also, I wouldn't think the CEO would use the word "encouraged" along with what I took as a general positive vibe in relation to what they are seeing if these are serious unanticipated AEs. So, hopefully these are truly AEs as a result of target suppression and that will eventually translate into efficacy, particularly in MM (I think that's the big opportunity here and that's where they saw the best results in their pre-clinical models).

But, I hear you on how far will they be able to ramp the dose up if they are already seeing some AEs at the lowest dose. I think that's a fair question. We will obviously just have to see the data in due time.
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mcbio

04/30/13 11:12 PM

#160570 RE: BTH #159397

CRIS

What do you take this to mean? "AEs consistent with target suppression". The Cohort1 is at 30mgs, Cohort2 at 60mgs. Should they have already seen AEs at the lowest dose level? I suppose if fhe drug is showing efficacy, and is doing its job, ok....but? And I am sure you know, 2 of the 3 patients in Cohort1 are multiple myeloma patients, refractory to two or more prior tx.

Per the CC today, CRIS expects to see similar activity in humans as they saw in animals at cohort 4 (which I assume extrapolates to 240mg if we assume a doubling of dose at each subsequent cohort). Sounded like all patients from cohort 1 (30mg) are still on treatment and one patient has completed their fourth cycle.