Allen has always sounded very confident of the tesmilifene phase 3 trial. He has not backed off. It is a blinded trial. I believe his confidence comes the first phase 3 trial with 140% increase in OS while this trials SPA requires only a 33% increase in OS.
Opinions wanted on how hard would it be to blind a study like this?
(Safety Profile The study demonstrated a good safety profile for tesmilifene. With the exception of neurological toxicities associated with tesmilifene (24% experienced hallucinations and 37% experienced dizziness), the rate of cardiovascular events is consistent with historical rates associated with doxorubicin alone. Other toxicities including GI symptoms and hematologic toxicities were also within the expected ranges for chemotherapies alone. The neurotoxicity associated with tesmilifene primarily occurred during the first cycle of dosing (70% of cases), and was shown to EASILY managed by sedation during the infusion.)
This is the first time I have heard him talk much about the pancreatic cancer trial. He did sound upbeat (same for pontine glioma). My guess is he knows the results are good and is waiting for the analysis to be completed. Did I hear him say equal or Better efficacy then erbitux? Bold talk. The analysis of these trials should be easy. Alive or not.
If Theracim was in fact more effective then erbitux with lower affinity, why? Better VEGF properties? A very bright guy (bioguy) on the IMCL board has stated that theracim does not cross the blood brain barrier and that if in fact theracim is working on these patients it is most likely because of vegf control. Of course more head to head data is needed to know for sure and I think Allen's his comments about theracim being equal to or better then erbitux are premature. At this point erbitux owns the data.
Does anyone know of any erbitux or abgx's mono trial results in pancreatic cancer?
Regarding theracim crossing the blood brain barrier YMI has sent me documentation of a mab with a radioiso attached and mri's proving the drug had been taken up by the tumor. This could happen if the tumor mass had crossed the barrier. I don' t know enough to argue these points. I guess as long as the drug works, who cares.
Thomas stated on the IHUB that potential partners would like to see mono results. If in fact the pontine glioma and pancreatic cancer results are better then expected this should help us get a partner for this drug.
Another brokerage firm also picked up coverage this week. I missed the name.
Over the next month or two I expect ymi to do very well.