"I assume that the SPA takes care of the difficulty of estimating the placebo effect"
the "placebo effect" - the endpoint here is survival ....... ?
"Why did not they do a one-arm trial instead and compare with historical data?"
Historical data varies from time to time and country to country.
"Any guess for royalty rate...."
If the partner waits, and the trial hits the endpoint, then YMI's negotiating position will be very good. I wouldn't sweat these details.
"Patients are randomized to one or the other arm so they cannot be cherry picked by who ever is executing the trial."
My recollection is that the Tesm trial is not randomized, for whatever reasons. Am I wrong ?
The arm of the trial that does not include tesmilifene is standard care for recurrent breast cancer. The other standard care treatment would be with taxotere. Patients are randomized to one or the other arm so they cannot be cherry picked by who ever is executing the trial.
The revenue sharing can very as can the up front payments. All we need to know is if we get a partnership this will not be a $3 stock anymore. You can research other stocks that have signed deals after successful phase 3 data if you want a general idea.
Thanks io_io and Randy,
I assume that the SPA takes care of the difficulty of estimating the placebo effect,
so we do not have to worry about that.
Why did not they do a one-arm trial instead and compare with historical data?
I assume any partnership about tesm will involev terms for development for other indications.
Any guess for royalty rate assuming results in this trial that are consistent with the previous trial or slightly worse?
Any guess what royalty rate YMI will receive
Revenue & Market:
It all depends on the trial, and the degree of success. If we get 30 months' survival, it should take off like any cancer drug. There will be "adverse events", hopefully not many laid at tesm's door, but in any case there is nothing pleasant about this business.
Especially as it presents a whole new class - I am not aware of any pure chemo-potentiators per se (although obviously chemo is used a lot in combination). Am pretty sure that tesm is not a knock-off of any like-cousin.
Of course it would be nice if that Taxotere+Tesm trial went well too, albeit small as it is.
If you look it up on clinicaltrials.gov, it is neither blinded nor randomized !
The tesm is a 6-hour infusion, with sedation (it is not at all pleasant to take). That is hard to "blind" against.
As for why they pre-select patients for tesm, perhaps it has to do with this too. Makes you wonder though why the placebos would not just drop out, I'm sure they feel like guinea-pigs. Maybe it's because everyone gets treated for free, maybe someone here knows better.
YMI pays a royalty of 4.16% to Manatoba. Currently all other revenue goes to YMI. When we get a partner I'am sure this will change.
There are 40,000 MBC patients per year, 25,000 treated with anthracyclines and the estimated cost of tesmilifene is 12 thousand per patient.
Penetration rate I'am sure will depend on the success of the trials. Griffen pegged it at 1% first year, 4% 2nd year, 12% 3rd year, and 20% 4th year.
I have a hard time believe that if survival is increased from 12 to 30% that we will see only 4% penetration by the 2nd year. The partner we get will also have a major influence in this area.
These are all estimates.
I asked about it being double blinded. I was told it was not.
The reason I asked the question is I thought it would be hard to do given he safety profile and the sedation given during treatment.
Safety Profile The study demonstrated a good safety profile for tesmilifene. With the exception of neurological toxicities associated with tesmilifene (24% experienced hallucinations and 37% experienced dizziness), the rate of cardiovascular events is consistent with historical rates associated with doxorubicin alone. Other toxicities including GI symptoms and hematologic toxicities were also within the expected ranges for chemotherapies alone. The neurotoxicity associated with tesmilifene primarily occurred during the first cycle of dosing (70% of cases), and was shown to easily managed by sedation during the infusion.