RE:RE:RE:RE:RE:RE:RE:RE:RE:No SP reaction to TH1902 good newsI wrote here that personnally I think they have proof of concept, but I also said that from a scientific standpoint they cannot claim that. One, patient with a partial response and two other with indirect signs of efficacy is not enought to make a scientific claim. That being said, if they would have confirmed that these three patients wer overexpressing sortilin, my conviction on proof of concept would be stronger, and their case to convince investors would be stronger. Understand me well, we much better off with the data they finally published, but it's still not enough. They cannot make big claims with that. My level of confidence is much higher now, but even though I think they have the proof of concept, I would not call it a proven fact. That's why I think that right now it is still a matter of personnal opinion. Somebody could easily argue that nothing is proven and he would be right on the unproven aspect. To put it another way, I think the risk of failure is much lower now with this news, but it's not zero.
SPCEO1 wrote: You were not convinced that sortilin overexpression is playing a role giventhe one patient who had failed on docetaxel alone, along with another taxane drug, but did respond to TH-1902? That convinced me.
jfm1330 wrote: The big info that is missing is confirmation that the patients that showed efficacy or signs of efficacy were overexpressing sortilin on their tumors. Again, they reported results about a targeted drug as if it was a systemic drug, like docetaxel alone. It is key to know if the link between TH1902 ans some level of sortilin overexpression has been establish. I am sure Thera either know the answer to that or want to know it. Prostate cancer is not a cancer known to overexpresse sortilin in 90%+ of the patients or advanced patient. At this point, the weak point is the fog surrounding sortilin, we know what they give to patients, but we don't know if these patients have the other part of the system, which is obviously sortilin in high amount.
SPCEO1 wrote: There is a lot left to learn about TH-1902. The 1a was simply a dose escalation trial and was not aiming to solve all the questions around the drug. As the trials move forward, more questions will be answered.
On our call with management, they indicated that the 1a data dump was all the info they had on the 1a. So, we got what they have. Now, I know they have more nuanced info that we would all like to hear about but that was what they said.
Also, I asked if the two patients who had rolled from the 1a into the 1b were still in the 1b but they said they did not feel they could share that info. If they are still in the 1b, then there is a possibility we hear about a preliminary sign of efficacy soon. If not, then the August/September time f rame should give us multiple opportunities to ehar about that. Now, they also backtracked on whether asingle sign of preliminary efficacy is still going to be deemed a material event. So, perhaps we will not hear that even if it occurs and will have to wait until they have enough evidence for one cancer type to approach the FDA about a 1b protocol amendment. I am assuming they would choose the cancer they want to proceed forward with if they have multiple options and then not look for other protocol amendments for other types of cancer but I really don't know.
In any event, following our call, what I can be sure of is there will be a PR regarding a protocol amendment if the data justifies it and that is a big step in the discovery/approval process if it occures.
LouisW wrote:
In 1a, the result is good. But they need to know why some patient responded to Th1902, why others did not. Then based on the result to define criteria to select patient for the larger trial.....to select patient only based on 300 patients staining data is not sufficient at all.