Friday, June 19, 2009

Labor and response rates

Is it really Friday already? That is great , especially considering that this weekend means another Father's Day for me. Do you think Lynley has grown tired of me pointing that out? I assure you she has bu,t she has come to expect that of me. I have so few times that I win that she knows I have to take full advantage of my opportunities. This of course, before she relegates me to the space under the deck again. It will be a fairly relaxing weekend. The kiddos have Tae Kwon Do sparring class tonight. This weekend Lynley has already begun to line out the work in the back yard. I have a few old fences to remove and a few new ones to repair. There are no specific kiddo activities which suits me just fine. That means a lazy time around the pool - for them, of course. Remember, they are management. I am labor.

I also wanted to quickly acknowledge one of the comments that I received earlier in the week regarding Fenretinide response rates. You may notice. I did not mention any. As most of you know that have listened to me discuss phase 1 trials at infinitem - I think they are misleading. There are too many variables that factor into a response rate in a phase 1 trial. It never comes down to one number and it absolutely CAN NOT give you any indication of activity without knowing the dose levels, the timing of responses, the disease burden of the patients, their disease characteristics, or a myriad of other factors. I bring this up because someone was trying to turn the responses I gave into a response rate. You can't do that and make it meaningful. First, I was discussing complete responses - not partial responses, not mixed responses, not slight movements in HVA/VMA. By the way, it is these COMPLETE response that I find to be so amazing about this trial. I did not expect that. Second, I was commenting on data that was only looking at a subset of patients on the trial - not all patients. The data in the abstract only really alluded to patients in dose levels 4 through 8 - dose levels high enough to achieve clinical activity. There is actually much more information of interest that was not in the short abstract. This drug has good activity and very low toxicity - even at higher levels - but the problem remains. How do we get enough of it into patients to really achieve the results we are looking for? Even with this formulation we eventually ran into issues - not with the drug - but with the carrier. Mark my words. Fenretinide has not only shown good activity but it can be much, much better. You just wait and see.

There is purpose behind those words.

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