Good morning! Well, for a change, I have had a bit of normalcy. Yesterday, everything went off as planned and ended up with a nice evening, once again, in the back yard. Thankfully, last night, Ainsley did not seem to have a problem with the 'N' or the 'O' part. So, from the kiddo standpoint it was pretty uneventful. In fact, it was downright normal. It was perfect.
With all of that being said I had the opportunity to do some more research this morning. It was that time of the week where I get to sit down and really read some research. Over the past week or there have been several new articles published that caught my attention. I have always been intrigued by articles which involved the immune system and, especially in light of the recent ch14.18 findings, I am attracted to them more than ever. I am not only happy for the incredible results of the ch14.18 trial. That is fabulous news. What makes me even happier though is that it will eventually increase the supply of antibody.
Why, you ask?
Well, the problem that we have had over the last few years is that we did not have any antibody supply. Essentially, all we have had was enough for two trials and this came in the form of ch14.18 and hu14.18-IL2. With the trial ending for hu14.18-IL2 it today is no longer available - even with some pretty good results. By the way, this is not to say that 3F8 was not available. It was, but just in one location and for one or two institutions. There was no antibody supply for anyone else. In other words if you wanted to do some really interesting antibody research out of Sloan you could do the preclinical work but your hope of actually getting enough antibody to get it into kids was nil - zip - zero. No one was interested in investing large sums of money into the manufacture of a drug which we had no strong indication that it was going to impact survival. So, in essence, unless you already had antibody supply for your trial, you weren't going to get any. This has been a significant struggle for researchers who were interested in moving antibody therapy trials forward. I can tell you of several examples of great research utilizing antibodies with combinations of NK cells, chemotherapy, and a slew of other targeted agents. It is hugely promising work. Unfortunately, until now, they could never get these combinations into kids because no one was willing to provide the drugs. It was a huge struggle and source of frustration for many within the NANT and the COG.
In a nut shell, we had all of this extremely promising research and no drug with which to move it into kids. The good news is that it is my belief that these results will loosen up the drug supply (once manufacturing catches up) and we will begin to see a flood of great antibody work moving into our kiddos.
It will take time - not because the researchers don't care, not because any of the consortiums are too bureaucratic, not because there is some conspiracy. It will take time because drug supply will be an issue. Think about it. It takes more than a year to ramp up production of an antibody - assuming you can find someone willing to pay for it and manufacture it on your schedule. We just found out that this is potentially helpful for more than 80% of high risk children. We are going to have to go from about 50 patients a year to about 300 as we work to get antibody into all of the kids that need it. Somebody has a lot of antibody to make and we need to make sure they get it(where we know it impacts survival) before we start experimenting (where we hope it impacts survival.)
It will take time but it is a great sign for the future. Two months ago we were years (if ever) from seeing antibody availability in any meaningful fashion. Today it is on the horizon. Today we can see it coming.
We have to wait but great things are coming.
Here that - it is purpose coming.
Wednesday, April 8, 2009
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1 comment:
This comment is really in response to yesterday's post. There's an old saying "what goes around, comes around" Go Ainsley!!
B at Caprock
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