Thursday, February 08, 2018 9:04:32 PM
PR 12/27/2017
Here are the primary outcome measures:
A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer
So with a slowly enrolling and likely under-dosed trial and successful determination of biomarker changes, what's reasonable? Keep going for a year to try to fully enroll the 2nd cohort or move along with data gleaned from Cohort 1? If there wasn't clear-cut biomarker effect from the cohort 1 then it'd make sense to proceed with cohort 2. In that the Kevetrin dosing is only 9 doses over 3 weeks, it makes little sense to continue the trial as a therapeutic trial. I think it would also be difficult to assess progression of disease with such a short therapeutic time-frame. The trial, as designed, is a tough sell to late stage patients. It makes a lot more sense to create conditions where a therapeutic trial can yield positive results beyond the 3 week dosing window. Biomarker information acquired from cohort 1. Well done. Move on to a therapeutic-focused trial.
Frequent oral dosing is certainly an understandable strategy for a short half life drug. I get it. Personally, and I've expressed this before, I'd like to see escalating dosing with a continuous infusion via a Port-A-Cath or Hickman like access port. User friendly portable devices are available. It's a more expensive and invasive approach but it'd tell us the therapeutic impact and side effects of steady state Kevetrin fairly quickly. Many of these late-stage patients already have indwelling venous access ports.
It's unfortunate that the board is barely readable. Some days I barely skim it and other days I don't bother as it's the same cast of characters who have zero impact on my buy/sell decisions. I continue to hold a substantial position and have not sold any shares.
Best of luck,
biodoc
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