Monday, February 24, 2014 8:47:26 PM
I went back a re-looked and did find the FDA approved dosing in a Jan15 PR.
As disclosed in December (See press release dated December 9, 2013), the Company had filed an amendment with the U.S. Food and Drug Administration (“FDA”) to modify the trial protocol to limit the dosing infusion timeframe to a maximum of six hours, versus the current protocol of 30 mg/m2 without a maximum infusion timeframe. As dosing continued to increase without yet reaching a MTD, the infusion duration became a concern as it could become quite lengthy. We are pleased to report that yesterday the FDA accepted our amendment. The FDA approval now allows for enrollment to begin of the seventh cohort under the amended protocol. The safety committee overseeing the trial has approved dosing to be increased to 165 mg/m2 with a 6-hour maximum infusion timeframe for the seventh cohort.
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