RE:RE:Delay in Phase 1 a --------Get over itIf Thera's goal with patient #2 was to tease us about some positive outcome they would have specefied what happened to this patient after the fourth cycle. We need to look at it objectively. His first dose was 60 mg/m2. A quarter of the MTD of docetaxel alone. I know they saw some efficacy in animal models at a quarter of the dose, but a real patient is not an animal model.
Marsolais in the KOL back in June said that they were close to the MTD of docetaxel alone at that point, so they were at 200 mg/m2, the third cycle of patient #2. So by the end of August it is sure that patient #2 had the four disclosed doses. After that, what happened to patient #2. That's seven months ago. If he continued at 300 mg/m2, why they did not disclose it? If he did a single cycle at 300 mg/m2 than dropped off the trial, it means he was on the drug for about four months. I don't see what conclusion we can draw from that.
I don't say nothing good happened to this patient. I just say that with what Thera disclosed, we cannot reach any conclusion. If the goal of disclosing that was to let us know TH1902 is effective, sorry, to me it's not the case. What happened to patients #2, #4 and #5 after the first 300 mg/m2 dose? Mystery. We don't know. Same for patients #8, #9, #10 and #11. They were treated at 420 mg/m2 for at least two doses. Are they still on the drug at a lower dose??? Again, we don't know.