RE:RE:RE:RE:Accumulation patternFrom my hopeful perspective, the strong preclinical results that got us an early FDA Fast Track designation and a solid lead investor in Soleus, as well as three patients responding in the phase 1a portion, all suggested the chances the drug might work well were good. But it is clear they have not been able to convince the testing centers doctors, at least in most cases, that the prospects for TH-1902 warrant paying it special attention and getting patients into the trial. Let's face it, PDC's are not "a big thing" yet in cancer research. It seems doctors often opt for immunotherapy tests above TH-1902 because immunotherapy is the current big thing. Also, had the phase 1a results shown really impressive results, the drug would have gotten more traction with the doctors in phase 1b. So, I am guessing the apparent enrollment problems are related mostly to the lack of traction for PDC drugs generally in these clinics and only modest results seen in early patients taking TH-1902. But I am only guessing since we have no significant info on these matters. Clearly, however, if 10 of 18 patients in the phase 1a had shown some success, and basically verified the good preclinical work, enrollment would likely be going faster in the phase 1b than it apparently has.
TH-1902 may yet be successful and beccome the next big thing. But it is clear to me at this point that its pathway to becoming the next big thing in cancer research is going to be harder than the early evidence suggested it could be. So, the risk is now a bit higher that we don't get the result we were hoping for with TH-1902. More likely, we may get a good result but it may take longer than we would like, as it already has.
Right now, we have no good news or bad news on TH-1902. The longer you go without good news, the higher the risk of bad news. But all of this could change in a flash if good news is announced which changes the narrative surrounding TH-1902's future prospects. At any moment TH could announce they are filing, or have already recieved, approval from the FDA for a protocol amendment to the trial and that would change all of our perceptions instantly as it would indicate the drug is working and could be on a pathway to a quick approval. Let's hope the patient who we need to have a successful result does not catch covid at the 11th hour and leaves the trial as happened with one of the phase 1a patients!
Wino115 wrote: Qwerty has the phase 1 progressing at around the pace other's have. I think THTX and we may have been far too aggressive with enrollment pace; hence, the addition of 3 months for full enrollment by CMO. If so, they may see something by year end, but it should no longer surprise us if it goes a few more months. It says nothing about efficacy, but just that the pace is slow as enrollment is competitive and complex and all this takes time. I think it's far more complex than we (or they) thought.
By way of example again, I think they're only recruiting at 4 of the 6 sites. All the places have large lists of solid tumor Phase 1 programs they are testing. So it's definitely competitive. I still see no listing for Cedars and none for START Midwest. I did find an archived one for Cedars, so it was listed at one point, but isn't up there now. START has 4 centers (3 US + Spain), but none list it that I could find. I would just add that I'm not really sure how accurate or up-to-date those lists are. It wouldn't surprise me if they only update a few times a year as I see a lot of the Cedars trials, when you click into the Clinicaltrial.gov listing, show they actually are no longer recruiting. Nonetheless, it woudl be worth asking if they can confirm there is actual recruitment going on beyond the 2 places we know are confirmed.
Wonder if Scarlet can get an update from his doctor on what's been going on in Detroit?
SPCEO1 wrote: There is a chance but since the company has said very little about the progress of the phase 1b it is hard to say how good a chance. But, starting about three months ago, patients who enrolled in the first three months of the trial should have gotten their second scan. We don't know how many patients that was exactly so we can't assume too much. Since they have not told us anything about enrollment other than they are looking for new sites and they expect it now to be done in March 2023, we can presume it has gone slower than they originally hoped for with a reasonable degree of accuracy.
So, for example, let's say the very first ovarian patient had a good response to TH-1902, but then the next three did not. Perhaps the fifth patient is now nearing their second scan and their first scan showed meaningful tumor reduction. TH may now be waiting for that second scan to happen before turning to the FDA to file a protocol amendment in ovarian cancer as 40% of the first 5 patients had good results. And they could easily have that by the end of the year. Or not, since this is just guessing about what the reality on the ground is.
I am not sure the company has ever formally backed away from Paul's comment in mid-August that there could be "a few, several or maybe many" reportable events from the phase 1b between then and Christmas. That rhetoric has disappeared, however, and the timeline for the trial has been stretched out from enrollment completed at the end of 2022 to the end of the first quarter 2023.
If there is good news on PoC, we will hear it as that is something they mucst report.
Trogarzon wrote: Any chance we get a POC update from the company before year end.....