Cellceutix Files Form 10-Q for Quarter Ended September 30, 2015 - Seite 2

Exposure to Kevetrin as measured by plasma concentrations have been achieved which are greater than concentrations shown to induce apoptosis in non-clinical studies. While the trial is primarily to evaluate safety of repeated cycles of Kevetrin, it is encouraging that some patients have had stabilization of tumor status during treatment. Further, Kevetrin appears to be having the expected effects on p53 in a number of the patients treated, as measured by increases in the levels of the downstream protein p21 biomarker.

Enough data has been collected in the Phase 1 study for now advancing Kevetrin to a Phase 2 clinical trial. This data is being used to design the Kevetrin dosing regimen in the planned studies of patients with advanced ovarian carcinoma. An FDA meeting request had been submitted in the last week of October 2015. Subject to FDA guidance and authorization, the Company plans a multi-arm study evaluating Kevetrin as a mono-therapy and as a component of a combination therapy. To date, pharmacokinetic profiles found that the plasma half-life of Kevetrin is relatively short, supporting the projected administration of multiple infusions each week in the next study. The half-lives after the first dose and after the sixth dose do not differ appreciably. Longer durations of Kevetrin infusion have shown prolonged exposure to the drug. Prolonged exposure and high area-under-the-curve (AUC) may be desirable in therapy of solid tumors especially with Kevetrin since activation of cell death signaling requires multiple gene synthesis and the phase or phases of the tumor cell cycle most susceptible to the effect(s) of Kevetrin is not known.

Kevetrin was granted FDA Orphan Drug Designation for the treatment of ovarian cancer.

In August 2015 an application was submitted to the FDA requesting a Rare Disease Designation for Kevetrin for the treatment of pediatric retinoblastoma. We are awaiting a response from the Agency.

We are pleased to report that we have submitted our first paper on Kevetrin and p53 for peer-review and publication at a relevant scientific journal. Now that significant clinical data has been collected on Kevetrin, it's time for us to begin publishing in peer-reviewed journals to complement the peer-reviewed data presented at oncology conferences. We believe that publications in scientific/medical journals will attract more attention towards Cellceutix and benefit our shareholders.