Cellceutix Provides Corporate Update - Seite 2

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.

Kevetrin- Acute Myelogenous Leukemia

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.

Kevetrin- Renal Cancers

We have also discussed plans for Kevetrin to be independently studied by investigators at Beth Israel Deaconess Medical Center (BIDMC) in combination with a tyrosine kinase inhibitor as a potential new combination therapy for renal cancer, a tumor that is particularly resistant to therapy. In its research, BIDMC has noted in vivo tumor regression in a drug-resistant renal cancer cell line exposed to the combination of Kevetrin and sunitinib. We have previously supplied BIDMC requested information to investigate a Specialized Programs of Research Excellence (SPORE) grant. It is hopeful these plans will progress to the initiation of a multicenter Phase 2 clinical study of Kevetrin in combination with a tyrosine kinase inhibitor.