Monday, May 25, 2015 1:02:29 AM
"AML will be receiving Keverin on multiple consecutive days, which we believe will increase p53 activity. The primary objective of this trial is to evaluate the rate of complete remission of AML in patients receiving Kevetrin alone or in combination with cytarabine. We believe that if the trial shows clinical activity of Kevetrin or Kevetrin plus cytarabine in the treatment of AML, a disease that the American Cancer Society estimates accounts for 20,830 new cases"
We have previously announced that Kevetrin will be studied in a trial being sponsored by the University of Bologna and its European partners. The initiation of this trial was intentionally delayed pending further evaluation of Kevetrin dosing in our ongoing Phase 1 study. We are pleased to report we have been notified that based upon the data from the Phase 1 study, the original protocol has been revised and expanded from what was originally planned to be a Phase 1b study into a Phase 2 trial evaluating Kevetrin as a single agent or in combination with cytarabine in patients with Acute Myelogenous Leukemia (AML). Over 100 patients are expected to be enrolled in the trial. The new protocol will be submitted in May by the principal investigator at the University of Bologna to the institutional committee. This is an important trial for Kevetrin as these AML patients will be receiving Kevetrin on multiple consecutive days, which we believe will increase p53 activity. The primary objective of this trial is to evaluate the rate of complete remission of AML in patients receiving Kevetrin alone or in combination with cytarabine. We believe that if the trial shows clinical activity of Kevetrin or Kevetrin plus cytarabine in the treatment of AML, a disease that the American Cancer Society estimates accounts for 20,830 new cases and 10,460 deaths annually in the United States, we will see a substantial rise in interest in Kevetrin for potential use in leukemias. - See more at: http://cellceutix.com/cellceutix-provides-corporate-update/#sthash.59oBfRqU.dpuf
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