Cellceutix Submits Briefing Book for Phase 2 Trial of p53 Targeting Drug for Ovarian Cancer

BEVERLY, MA--(Marketwired - January 19, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the briefing book with data collected during the Phase 1 clinical trial of Kevetrin for various advanced solid tumors has already been submitted to the U.S. Food and Drug Administration (FDA). This briefing book submission is in advance of the FDA meeting to discuss the planned Phase 2 clinical trial of Kevetrin for advanced ovarian cancer. Cellceutix is developing Kevetrin for ovarian cancer under an FDA Orphan Drug designation.

48 advanced-stage cancer patients were enrolled in the Phase 1 trial and received at least one dose of Kevetrin. 11 of the 48 patients in the trial had advanced ovarian cancer. 

Kevetrin has a unique mechanism of action that enhances activity of p53, a key tumor suppressor protein, in both wild type and mutant p53-expressing tumors. In the Phase 1 trial, p53 activity is measured by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. p21 increased by ≥ 10% in 48% of the 31 evaluable patients to date. Importantly, with respect to the planned Phase 2 trial for ovarian cancer, 8 of 11 subjects (73%) with advanced ovarian cancer had increases in p21 expression, indicative of activation of p53.

No evidence of adverse effects on liver, kidney or hematologic function related to Kevetrin was observed, regardless of dose. Therapeutic efficacy was not an endpoint in the Phase 1 trial. However, RECIST (Response Evaluation Criteria In Solid Tumors) criteria were used and several subjects had stable disease for several months during a Kevetrin treatment cycle of one dose per week for three weeks and then one week off. The longest enrolled subject has completed 15 cycles and remains enrolled in the trial. 

In the planned Phase 2 ovarian cancer trial, Cellceutix intends to leverage the short half-life and strong pharmacokinetic profile of Kevetrin to change Kevetrin dosing from a single dose weekly to multiple doses weekly. The company expects that this will further increase p53 activity.

Ovarian cancer is a disease with a large unmet medical need and represents one of the fastest paths for approval for a clinically successful drug.

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