Today’s the day. The day a filthy reverse merger bioturd called Tyme Technologies hosts a conference call to discuss the early results from it’s ongoing study of SM-88, a cocktail of 3 already approved drugs plus their magic Tyrosine.
We’ve already examined the birth of TYME, and its relationship to not one, but two, sanctioned lawyers and one moonlighting sell side shill, in Part 1, here. We’ve also looked at the four clinical trials testing SM-88, and learned that not a single one is truly legitimate. These “studies” have neither control arms nor double-blinding. Read more about them in Part 2, here.
Right now let’s look at the early data for the pancreatic cancer study, NCT03512756. It can be found in this abstract.
So, although the original study plan was for 115 participants, as of September 2018 the company had only managed to enroll 36.
Of these 36 subjects, only 83% (30/36) remained on treatment. What happened to the other 6?
Of the 30 that remained on treatment, only 16 were “evaluable” for CTC (Circulating Tumor Cell) blood testing. What happened to the other 14?
Of the 16 that received CTC tests, 11 showed reductions. Sounds impressive, but something is off about this. Nowhere in the clinical trial record does it actually mention CTCs as being an outcome measure! The only listed outcome measure of this study is Overall Response Rate using RECIST 1.1:
The abstract continues, mentioning that 2 of 9 subjects showed CA19.9 (a tumor marker for pancreatic cancer) declines. But CA19.9 is not an outcome measure. And where did this group of 9 patients come from? What happened to the others?
Less and less patients seem to be available as the abstract continues. Only 6 were eligible for the initial scheduled assessment. And 3 of 4 had what the company called “RECIST or PET SUV responses”.
What happened to the other 2 out of 6? And why the change from using only RECIST as the outcome measurement? PET SUV is not part of the study protocol. One can be sure that if the patients actually had a true RECIST response, PET SUV would never have been mentioned.
One can expect the scum behind this biodreck to hype these results, 3/4 = 75% ORR using their bucket shop math, but the real number, if one wanted to look at this data in the most favorable light possible is that only 3/36 patients had a measurable response.
36 patients enrolled
30 patients remained on treatment
16 patients were evaluable for CTC – Not a real, specified, outcome measure.
9 patients evaluable for CA19.9 – Not a real, specified, outcome measure.
6 patients made it to initial assessment
4 patients were actually evaluated
3 patients had a response using a non-standard criteria not in the clinical trial plan
3/36. That’s 8.3%. In an unblinded study. And even then, the study is so poorly designed it is impossible to tell which agent, or agents, had any activity.
Fail.
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