Cellceutix Plans for Phase 2 Clinical Trial in Ovarian Cancer

BEVERLY, MA–(Marketwired – September 08, 2015) – 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 announce that it will be concluding its Phase 1 trial of the novel compound Kevetrin in patients with advanced solid tumors at the completion of the current cohort. The final cohort requires that six patients be treated at the maximum tolerated dose. Three of the six patients in the cohort have already completed the required treatments with Kevetrin. Cellceutix has been advised that the remaining three patients are currently being recruited.

In July, Cellceutix received an Orphan Drug designation for Kevetrin for the treatment of ovarian cancer from the U.S. Food and Drug Administration. Ovarian cancer is usually treated with platinum-based therapies where resistance develops quickly. The soon-to-be completed Phase 1 trial has provided robust data on the safety of Kevetrin treatment and compelling data with respect to ovarian cancer, some of which has already been publicly disclosed by Cellceutix. The conclusion of the trial fits with the Company’s strategic plan to initiate a Phase 2 trial of Kevetrin for ovarian cancer, a notoriously difficult disease to treat and a great area of unmet medical need in a major cancer market. The protocol for the next study is currently being written, with preliminary plans for the trial to be a multi-arm study evaluating Kevetrin as a monotherapy and as a component of combination therapy.

“I am encouraged and excited about the clinical direction of Kevetrin, as I believe ovarian cancer represents one of the fastest paths to potential approval,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “With the conclusion of the Phase 1 trial, clinical development of Kevetrin is going to greatly expand and accelerate as we aim to realize the full potential of this p53-targeting compound.”

Cellceutix also wishes to inform shareholders that it is preparing a proxy statement to be filed with the Securities and Exchange Commission for the Company’s first Annual General Meeting of Shareholders. More details are to follow.