Drug in the pipeline starting clinical trials

InNexus Biotechnology will introduce to investors/others their new formulation for an antiherceptin drug, which they hope will eventually get FDA approval. As Sassa said, first they start with mice testing. Recently I read that while historically, of mice and men has always been the initial first step in drug testing, the Genome Project is suggesting gene reasons why mice testing may not be the way to go from the get go (too large a difference in genes to continue along this line). Of course, no one recommended a substitute, unless they test drugs in the lab directly on different types of breast cancer cells but this has distinct limitations of not seeing the mouse keel over. Maybe Sassa knows something on all of where this may go.



They do not mention that the new formulation is one which lowers cardiac toxicity. I have heard this is being attempted so it must not be this company. Their push is on higher potency against HER+ cells.



InNexus Biotechnology is a company focused on monoclonal antibody pharmaceuticals. Another example of this type of technology (although dont' know if they make it) is Avastin.



Tender

Yes, Beth, good points.



You don't hear much about Herceptin resistance, but just like the hormonals, with continued use, some cancers become more resistant to them. So Tykerb was developed, adding a small molecule vegf to try to suppress intracellular cross talk and resistance.



The blub posted above just validates the company is planning to come out with a new anti HER drug: it doesn't say about less susceptible to resistance, less cardio toxic etc... But it gives a number to call if you want to listen to their investment specs and info.



Regarding the AI responders and genetic polymorphism: I've been keeping a peripheral eye on this for months now (I promised Iodine I would post if I ever saw anything of significance). One small (32 people) Korean studied looked at Arimidex and CYP3A4,5, 7 gene polymorphism I believe There are differences amongst us, but no large, clear difference with AI metabolism has surfaced as yet that I am aware of.



I believe the researchers at Mayo are doing a trial of some sorts on AI's and gene polymorphisms. It may be a retrospective of tissue already obtained, and then correlating the DFS and OS but I don't know. I just heard that your question is being looked at.



I do believe too, there is a prospective clinical trial on AI's and gene polymorphism listed on clinicaltrials.gov that is occurring overseas: ?Europe. Just not here in the States.



I'm just wondering if we all should have been having serial serum estradiol levels (properly run of course, which is an issue in and of itself) drawn to ensure we were down in the 7 to 9 pg/ml range all these years. I regret that I didn't, especially because I have few hot flashes. With my head in the sand, I just swallowed the pill, as the guidelines don't call for questioning about hot flashes nor measurement of AI suppressed estradiol levels.



Oops! Time to come up for some self-advocacy air! Great questions, Beth and thanks cp418.

Tender