An explanation from a post on the Raging Bull boards. This guy seems to have some medical background and is feeling more positive than negative towards Evacet's prospects. It reads as follows:
No, actually I was referencing a Phase II study done by the lead Evacet researcher, Dr. Batist. I see by Ava-bomb's report that they do refer to the Shapiro Phase II study--and if that is what they are basing their "sell" on, we should all be very relieved.
The Shapiro Phase II--again, a dose-finding, push-the-dose-beyond-the-max level study--used a dosing schedule and regimen that you would not see used in any oncology practice. Dosing of regular doxorubicin is a bolus dose of 60 to 75 mg/m2 every 3 weeks, with a MAX LIFETIME DOSE OF 450 MG/M2. The dosing benefit of Evacet comes not in increasing the bolus dose, but in increasing the TOTAL LIFETIME DOSE. Patients in Evacet studies have received over 1200 mg/m2 total (lifetime) dose of Evacet with reduced (and in some cases, no) cardiotoxicity. Why is this important? Think of the breast tumor as peeling an onion (sorry, its kinda late and this is the best analogy I can come up with). There's a certain dose of chemo that will kill that outer layer of cells--giving more chemo in that round won't kill those cells any deader. However, if you "blow your wad" (so to speak) and only get the outer 3 layers of the onion peeled by the time you reach your max lifetime dose, you still have a ball of onion (live tumor) left. However, if you pace your doses and give just enough each time to kill the next layer, then you can keep giving your chemo until you've peeled the whole onion and there's none left. However, this can't always be done with regular dox, because after you've peeled only a few layers you start getting cardiotoxicity, and you have to stop giving the chemo, or wait so long in between rounds that the tumor has a chance to regrow the layer you just peeled. With Evacet, you can keep peeling until the whole tumor is gone, with less chance of severe cardiotox.
Another point: remember that all drug studies are designed with the help, input, and approval of the FDA. No drug company just goes off and does a study, and then calls up the FDA and says, "hey, lookee here!!!" Drug studies cost big bucks, and you do the ones that the FDA tells you they want you to do to get a drug approved.
Thirdly, the Shapiro is a minor, small, Phase II study (50 patients). It is countered with Evacet studies of hundreds and hundreds of patients (300 patients in one phase 3 alone). These major phase 3's are what the FDA will be closely examining.
One final fun point to think about before you go buy some more Lipo in the morning: the Phase 2 Batist study I referred to in my previous post showed responses to Evacet in visceral sites (remember, metastatic breast cancer means a tumor in the breast, plus cancer cells that have broken off and lodged in the lungs, liver,etc, also known as your viscera--like if you met OJ in a dark alley, and he EVISCERATES you--you automatically know what soft, important parts of your anatomy I am referring to). Anyway, it a rare good thing when a chemo agent kills those "visceral site" cancer cells, because they are notoriously hard to kill. In the study I referred to, 4 of 8 patients with lung TUMORS (cells broke off and actually grew in the lung into a whole new onion) had those lung tumors shrink or disappear with Evacet. Wonder what all those guys who treat lung cancer (a leading killer) are gonna think when they see that???
Here's what I think: $$$$$$$$$$$$$$$$$$$$$$$$$$$$$
OOOHHH!! That is so exciting, it gives me a funny feeling "down there." Uh, sorry, gotta go now, gotta take care of something.
POW!!! TO THE MOON, LIPO!!!!!
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