Cohort 1 small dose into the tumor cavity. 3 out of 4 registered with disease control.
Cohort 2 small dose into tumor cavity and brain cavity. So same dose as cohort 1, but into two locations. 2 out of 3 registered with disease control.
Cohort 3, middle range dose into tumor cavity and brain cavity. First patient has been dosed. This is the first true dose escalation. Suspect they will aim for 4 patients in total, and if safety is demonstrated they will move to cohort 4.
Patients treated have approx 6 months of life expectancy. New patients are used for each cohort. Recruitment is slow as it is a single site trial for now. They expect to have two more trial sites up and running by mid year.
Complete response is absolute holy grail and chances of it are remote. Partial response is a big step up from disease control, so if we start seeing some of those… then this will start to get very interesting. But if even one complete response is registered, in cohort 3 or 4. Then this will IMO be elevated to a totally new league. CHM are treating arguable the hardest to treat cancer … the bar the FDA is willing to approve the product is probably quite low, so whilst a complete response is absolutely the best outcome- CHM will not need that for FDA approval or for this treatment or trial to be considered a success.
this is very much a proof of concept trial and if CLTX provides to be able to treat GBM consistently, safely and effectively, it will simply be the start of a brand new treatment paradigm that never existed prior to this trial. Combination studies, enhanced CLTX or NK-CAR… the possibilities are endless. And we have the IP for it all. But we need to demonstrate that we can walk before we run.
CHM Price at posting:
15.0¢ Sentiment: Buy Disclosure: Held
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