RE:RE:RE:RE:RE:RE:RE:RE:RE:Very encouraging, but approval will take timeI know it's not very important at this point, but it's worth noting that if the new protocol works, this drug will be high a high maintenance drug with three IV infusions per month, every month. Better start thinking now about an IV push formulation!!!
jfm1330 wrote: My understanding is that they stopped the trial because the see this drug as a drug for chronic use, so longer term use and patients can stay on a drug for a longer period of time only if toxic side-effects are relatively low. In my fourth month of chemo, I can tell you that it is a very important criteria. You need to retain a decent quality of life to stay on a drug long term.
SPCEO1 wrote: I am no scientist but the toxicity did not seem to be very bad based on my understanding of what levels of toxicity other drugs cause cancer patients. It seemed to me the decision to pause was that the toxicity, while not as bad as many cancer drugs, was still not worth it based on the limited efficacy. Did I understand that correctly? Or was the toxicity bad enough on its own to stop the trial. My impression is if TH-1902 had seen more efficacy, the trial would not ahve been paused due to side-effects.
scarlet1967 wrote: I don't think they mentioned the path to approval is SD even so having extended period of stable disease among heavily treated patients is impressive. The eye toxicity seems to be manageable by prophylactics the nerv issue based on Dr. Merci's past experience and as per Christian's comments(pre clinical observations) is supposed to be dealt with based on lower and more frequently dosing this time also based on body weight rather than surface maybe because cancer patients loose weight because of cancer itself and treatments so they can get that tolerable dose more confidently and accurately?!
Again a lot of info during a rather short time, they could do with a longer call in my opinion rather than rushing through questions. Nothing about the timing, funding and very little about partnership if any. My impression is they are hopeful/more positive about getting efficacy but worried about toxicity issues as it seems the new design has bits added to it to deal with the issue..,