RE:RE:Updated clinical trial This website is known for not being timely. For example, someone posted here some time back that the Mary Crowley cancer center in Texas was recruiting for pancreatic patients probably over a month ago. In any event, it is nice to know Cedars Sinai has finally kicked into gear, but perhaps that also happened quite some time ago.
TH has been very quiet for quite some time now. Is that a reflection of them having good info they are storing up for a big pre-financing reveal? Or is it a reflection they have nothing to tell us that we really want to hear and are hoping to get data soon that will allow them to put a positive spin on the TH-1902 trial? Or a bit of both. Probably a bit of both.
The lack of detail regarding the phase 1a trial, and its seemingly sporadic level of activity and inordinate amount of time it took to complete, suggest there were issues that we wish we already knew about but which the company has been able to keep silent about by saying almost nothing about the trial at all other than it is completed and a safe dose was obtained. Now, that is defintely good news and we are all happy the trial did not get deep sixed right out of the gate, but we would like to know if it ever came close to getting shut down altogether. Remember, Dr. Rothenberg was brought in last October. Was he brought in because things were going so well and they needed expert guidance to maximize the opportunity or was he brought in because the trial had hit a snag and they needed someone with his credibility to help convince the trial investigators to keep things on track? Remember too they took down the corporate presentation for a while last December before bringing it back largely unchanged from the one they took down - were their questions about what was in the corporate presentation that during that time period they felt might not be accurate due to what they were seeing in the phase 1a and took it down until they could justifiably present that info again? Who knows? But they did put it back up again and the phase 1a did achieve its objective. We may never know all the drama that may have taken place behind the scenes. But the trial is moving forward, new centers are now recruiting (fewer than I would have hoped at this point though) and we are getting closer to when we might reasonably expect to start seeing signs of preliminary efficacy (chances rise in the August/September time period assuming early enrollment in the phase 1b was not been light).
My best guess is there was both good and bad info obtained in the phase 1a and TH has chosen to keep both from the public for now with the hope that preliminary signs of efficacy in the phase 1b will be the ticket to a better fund raising opportunity. If TH-1902 actually works, we should know that pretty soon. My window for the earliest possibility of hearing about efficacy has passed as I am guessing the first three patients at the 300mg dosage level that likely signed up for the phase 1a trial in late March/early April have had their 12 week scan, assuming they even rolled into the phase 1b. As we have seen from Juniper88's account, however, the presumed timetables based on the trial protocols may not be 100% accurate in real life so my guesses about timing could be off and we do not even know if any of the first three patients at the 300mg dose level rolled into the phase 1b trial just as it started on May 10th or ever.
If some or all of the three patients in the second round of 300mg dose patients started in the phase 1a shortly after the first three completed their first three week cycle of treatment, then we might see a preliminary sign of efficacy in mid July. But, again, TH has not revelaed anything about whether any phase 1a patients rolled into the phase 1b or anything at all about enrollment. So, this is just a lot of guesswork based on the little we know. Starting in early August, the chances of getting a press release from TH telling us preliminary signs of efficacy have been seen in at least one patient start to rise as we know for certain the trial started on May 10th. After that, it is just a matter of how quickly they were able to enroll patients.
One thing I would like to ask Qwerty is about proof of concept. If TH has seen tumors shrinking say after even just one or two cycles of treatment, does that qualify scientifically of proof of concept - that the drug is being attracte to sortilin receptors, getting into cancer cells and killing them? Or does that not count scientifically and proof of concept can only be claimed after confirmed tumor shrinkage of 20% or more after 12 weeks? If proof of concept can be claimed prior to preliminary signals of efficacy, does anyone know if that is viewed as a material event that would need to be disclosed? I am just wondering if it is possible we first hear about proof of concept and later about preliminary efficacy, assuming either or both are achieved.
qwerty22 wrote: The only changes are cedar Sinai and Mary Crowley center are now recruiting.