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Re: biodoc post# 100217

Saturday, 05/02/2015 2:10:34 PM

Saturday, May 02, 2015 2:10:34 PM

Post# of 403091
Biodoc, you made some excellent points. The original infusion rate was 30 mg/m2. So it would take 25 hours dosing time at the current dosage! The FDA must have known about the short half-life, that’s why they agreed to a maximum infusion timeframe of six hours. By the time the patient finished dosing after six hours, the amount of Kevetrin remained in the bloodstream should be about 50% of the dosage. No wonder the MAD still has not reached yet.

This is why I’m really looking forward to the AML trial, since the patients will be receiving K on multiple consecutive days. The preclinical data show potent efficacy with a more frequent dosing schedule.

The ovarian cancer patient had the spleen lesion disappeared after three months. That’s only nine doses at 350 mg/m2. If she could receive K on multiple consecutive days, the nine doses could be achieved in less than a month! With such a strong safety profile and a really short half-life, I understand why management is so optimistic about the future of K.

"We intend to complete this trial in the coming months and initiate a follow on trial later in 2015 evaluating multiple weekly dose regimens of Kevetrin. The data that we have to date lead us to be very optimistic about the potential for Kevetrin."

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