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Old 08-22-2008, 07:08 PM   #39
Lani
Senior Member
 
Join Date: Mar 2006
Posts: 4,783
TSund and Jean

First TSund--the reason herceptin could be given off-label adjuvantly for bc was that herceptin was already approved for metastatic bc. That is the point of the term "off-label" use--it is use of a drug already approved for a different
indication for another disease/affliction for which it is not yet (or ever) approved.

Jean--I thought the way to move this forward was to help the researchers at Baylor get a hold of specimens and histories of her2+ patinets--especially her2+ER+ patients. When I last spoike up about this at an ASCO poster exhibit
I think it was with the Susan Komen people, they offered me a handout regarding how Komen could help with this and what they were already doing.

It had been many many months since I had heard from/tumor repository" and only about 5% or those who read the original post about how many would donate their specimen and give access to their records responded, causing me feel my efforts were better directed elsewhere.

I have been in touch with the Baylor people (saw them at ASCO and the Era of Hope), pointing out to them some interesting work being done by Jose Baselga's group in Spain(poster at ASCO) on how giving herceptin and tykerb "turbs" up the ADCC immune reaction against her2 and am aware that Mark Slikowski at Genentech has been supplying the samples to the Baselga group for their studies and is cooperating with them.

I also attended THE annual AACR meeting and heard Axel Ullrich, whom they
lauded as the true "inventor" of herceptin and provided with a "lifetime achievement award" explaining that her3 will be the key to curing her2 breast cancer.

I have heard Max Wicha at both AACR and ASCO describe how her 2 regulates the percentage of and invasiveness of cancer stem cells in breast tumors and, in general, asked lots of questions and alluded to the fact that
a repositiory of sample awaits interested researchers if the finances, legalities and logisitics could be worked out.

Max Wicha is starting a multicenter trial with a gamma secretase inhibitor (already FDA approved for Alzheimers I believe) trying to eliminate the cancer stem cells and thus the reucrrences of breast cancer.

I posted earlier an article which unfortunately should some increased cardiotoxicity adding pertuzumab (not FDA approved) to herceptin--I am sure Genentech, which has been on a roll with its products, is hesitant to begin a trial with the indication that there may be increased cardiotoxicity of the combination.

Another problem is that Iressa is approved but only for a VERY narrow indication and it is made by a different drug company than the other two drugs (which are made by Genentech). Genentech also makes an oral EGFR inhibiting TKI, Tarceva. It is very diffcult to get different drug companies to cooperate in a clinical trial.

The best hope would be Genentech--but they are about to be bought out by their majority stockholder, Roche --a much less innovative compnay who spend much less of their income on basic research and have a very different corporate "behavior" it would seem.

I don't know what her2 support as a group can do other than write letters to Roche, should they get their way, urging them not to change the governance or modus operandi of Genentech (but money talks, not letters!)

After attending 7 maor meetings in the last 12 months, I may only attend one more before San Antonio. I will continue to try to find out what is
holding up this trial and get back to your on what might be done to speed it up.
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