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slcimmuno

03/17/18 12:02 PM

#221374 RE: PlentyParanoid #221373

Thx for the digging

Onxeo and their OM Drug candidate, Valdive, later licensed to Monopar, also has had lots of sleight of hand...

If you go way back in time and look at original trial design, Incidence was an exploratory-only endpoint. Just look at all the changes to ClinicalTrials.gov
Monopar later sliced the subset data even further to claim, de facto, a higher incident reduction rate.

Yep: BRI OM, as an easy to administer oral rinse to help keep the S/OM away — a strong case for one of (if not) the leading OM Drug candidate, esp given how it could extend into chemo-induced OM, 650k or more Patients.

BTD imo looking good.

And have to think some Rx will want to Partner.

MinnieM

03/17/18 4:02 PM

#221405 RE: PlentyParanoid #221373

Thanks for digging this information up. ;)





In Reply to 'PlentyParanoid'
Correct. I interpreted Galera's swimlanes. I am, as you seem to be, waiting some kind of publication of their p2 results. Nothing, so far, at ClinicalTrials.gov. But the filing has one interesting tidbit:

Galera likes to publish it's trial minimum cumulative radiation requirement as 60 Gy. At first glance that looks like higher requirement than IPIX's 55 Gy. But IPIX's minimum is for ORAL CAVITY (ie. the target environment) while GALERA ALWAYS publishes numbers for TUMOR (ie. the target only). In the filing at ClinicalTrials GALERA lists the minimum for oral cavity as 50 Gy.
Quote:
"Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy"

This is important because SOM incidence rate and probably also duration goes up with cumulative radiation dose --> GALERA's published results seem to be for less demanding setting than those reported by IPIX.

Impressive for oral rinse.