The main purpose of phase 1 is toxicity, and the most concerning of dendrimer is level of toxicity in term of the platform itself and the side effect of the drug load. It doesnt completely like the clinical trial of new drug, which the phase 2 in efficiency is more important. In this case drug load is proven, the question is how far the side effect can reduce, and which level of dosing we can reach.
TAXOTERE
So far we know:
https://www.drugs.com/sfx/docetaxel-side-effects.html
"Very common (10% or more): Neutropenia (up to 99%), leukopenia (up to 99%), thrombocytopenia (up to 39%), anemia (up to 94%)"
Even handful of patients, we have amazing no neutropenia in comparison with 75-99% of normal rate
Here is phase 1 results of BIND-014 Docetaxel which is nasty (7/7 developing Neutropenia in different level in maximum dose - no improve)
BIND-014 is also polymeric drug delivery system,but they have problem in controlling size of particles cause they use nanoemulsion to synthesize. So they failed in phase 2 of trials
In the other hand, Dendrimer synthetic processes can also
precisely control the
size and number of branches on the
dendrimer, and makes it have wide range compatible with different characteristics of drug load
http://clincancerres.aacrjournals.org/content/22/13/3157.long
I suspect astrazeneca is very impressive, they brought everything to UK to validate results under their hands, and issue big announce once they believe (kind of "too good to be true"). Astrazeneca may now control DEP DOX program, we need the hand of big pharma to push it as fast as we could.
