RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Pre-Clinical only! To me it doesn't make any scientific sense to write such a paper. You can certainly comment like "we saw this in mice and dogs and that in humans" but you can't really do any real comparisons. I understand why this would be great but I just don't expect it to exist. Very rarely when things go well do you do much looking back to preclinical for insight, you rely on Ph2/Ph3. If things go wrong you might go back to preclinical for explanations.
I also think the human populations are very different. Docetaxel was the first taxane in the 1990s. It was being tested on non-resistant patients. THTX is forced into testing on heavily pretreated individuals with all sorts of resistances.
There's some preclinical docetaxel data dating back to it's first testing in mid- to late-1990s. It sounds a lot like what THTX is saying when it comes to in vitro and in vivo testing.
SPCEO1 wrote: IS there any data out there easily findable that compares the results of Docetaxel in its original pre-clincial trials to the ultimate impact it had on actual tumpor in human testing? If so, could that be a good indicator of what to expect from TH-1902 in humans? Did the original Docetaxel tests inmice hold up roughly as well in humans or was there a fall-off in effectiveness?
jfm1330 wrote: Yes but this is the most important thing and the one about which we have zero data. To stay positive you say to yourself that they would not present these results at AACR if they would see absolutely nothing towards a proof of concept in the phase Ia. I mean by that at least stable disease and positive PK/PD data. In the latest articles, they are comparing TH1902 to docetaxel at the MTD of docetaxel alone and see efficacy. So it's hard to believe that patients that got 420 mg/m2 for at least two cycles had no efficacy signs if they were overexpressing sortilin. But again, real tumors in real humans is very different from tumors grafts on mice and you always wonder if docetaxel will be efficacious at higher intracellular concentrations on relapsed cancers with no effective treatment remaining.
LouisW wrote: All we need is the human efficacy data, then all the dots can be connected.