As we explored in Part 1, the provenance of Tyme Technologies (TYME) is hardly encouraging. We have a saying at BuyersStrike! HQ, “Past is prologue, always” but some might argue that past association with notorious scam lawyers Diane Harrison and Adam Gottbetter, along with a shady IR/bucket shop shill, Raghuram Selvaraju, doesn’t reflect the amazing potential of Tyme’s cancer treatment, SM-88.
Quite the contrary, Tyme’s past completely predicts Tyme’s nonsense treatment, its poorly designed trials, and its terrible efficacy.
SM-88 is actually a combination of four compounds, three of which are already approved drugs, easily available.
Sirolimus aka Rapamune (rapamycin)
Dilantin (phenytoin)
Uvadex (methoxsalen)
and
“Magic” Tyrosine (a modified form of Tyrosine, a non-essential amino acid)
Rapamune and related drug Afinitor are already used in oncology. So is Uvadex. Dilantin was once commonly prescribed to brain cancer patients for seizure suppression, but there have not been any reports of improved outcomes with Dilantin therapy.
With 2 known, and potentially 4 active compounds in this cocktail, one would think a study should have at least two arms:
- SM-88 arm (R+D+U+mT)
- R+D+U arm (active comparator)
Or better yet, to be considered well designed, at least 8 arms:
- SM-88 arm
- Rapamune only arm
- Dilantin only arm
- Uvadex only arm
- R+D+U arm
- R+D arm
- R+U arm
- D+U arm
Let’s see what clinical trials the good people at Tyme are actually running.
A quick search on Clinicaltrials.gov shows four studies. Two are recruiting, two are not yet recruiting.
First up is study NCT02562612, a breast cancer study entitled, simply, “Study of SM-88 in Advanced Cancers“. This study was announced in 2015, but as of today is still not enrolling.
According to the company, the goal of the study is:
To assess the response rate and PFS in previously treated breast cancer patients. Additional objectives include the pharmacokinetics of multiple ascending doses of SM-88, a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer. Secondary objectives of this study include an assessment of safety and tolerability of ascending doses of orally administered SM-88. Additional response data will also be collected.
Overall response rate (complete response + partial response) by central review of modified RECIST 1.1 using blinded independent central review (BICR) of radiological scans.
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