SPCEO1 wrote: There is no doubt there is a lot we do not know yet. But we do know that TH did decide to share some additional info with us and it seems like the news that patient #2 went through multiple dosage levels and cycles was a message they intended to convey to investors. I don't think they were trying to offer us any proof, just trying to keep us hopeful until the final results are out. Since most investors are not scientists looking for definitive proof before they get more optimistic, I think TH revealing this now was a good strategy. With the sizable delays in the phase 1a, investors needed something to hold onto to remain hopeful about the outcome.
Now, they are likely in the midst of dosing the last three patients at 300mg right now. So, we will hear the final results of the phase 1a before too much longer if Christian was right with his expectations based on prior bloodwork that the 300mg dose will not encounter the same toxicities that those at the 420mg dose saw. Since the number of patients are so small, there will be nothing statistically significant in that data but we could walk away from reviewing knowing that the phase 1b and phase 2 trials stand a very good chance of giving the scientists the statistical significance they are looking for. What is key for investors at this point is for the phase 1a to give TH a legitimate future in cancer and not be a failure that requires TH to return to the drawing board. Based on statements the company has made, patient #2 and actions the company is taking, it is not too hard to convince oneself that TH-1902 still has an interesting future and its prospects have not been cut off at the knees with the first human testing. That needs to be officially confirmed and I expect there will be some phase 1a data revealed that will keep us worrying to some degree about the next round of testing, but that is normal.
I imagine that statistical significance will be hard/nearly impossible to achieve in phase 1b as well with only 10 patients per cancer type for most of the cancer types tested. Could statistical significance be calculated if there are 30 responders across 75 patients in multiple cancer types or would each cancer type have to be viewed individually?
jfm1330 wrote: If 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.