Company to Seek Guidance to Pursue Phase 2/3 Trial of Kevetrin
BEVERLY, MA–(Marketwired – May 22, 2015)– Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the Institutional Review Board (“IRB”) overseeing the Company’s Phase 1 clinical trial of Kevetrin for the treatment of advanced solid tumors being conducted at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center has approved the amended protocol to allow additional patient enrollment to the study.
The original protocol for the trial specified 40 patients to be enrolled. Due to maximum tolerated dose (“MTD”) not yet being identified and data indicating that the effect of Kevetrin on p53, a key tumor suppressor protein often referred to as the “Guardian of the Genome,” is dose dependent as expected, Cellceutix requested an amendment to the protocol to continue to evaluate administration of Kevetrin at higher doses. The trial is currently in its eleventh cohort, with one patient (the 40th in the trial) having received two infusions of Kevetrin at 750 mg/m2. The Company has been advised that screening of additional patients is underway and they are expected to be enrolled into the study.
“We interpret the IRB approval as a strong vote of confidence as to the safety and potential impact of Kevetrin to deliver a meaningful effect on p53, a protein that researchers have been trying for decades to safely revitalize to unlock better clinical outcomes in the millions of cancer patients where the p53 pathway is damaged,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix. “We could have concluded the trial with the completion of the target enrollment, but we have a novel drug delivering compelling data that we want to push to the limit to best direct the scope of future studies. With regards to cancer, the U.S. Food and Drug Administration is doing a tremendous job with initiatives, programs, and support of trial designs to expedite the development of safe and effective new cancer treatments to get them to patients that so desperately need them. Effectively, this is blurring the lines of traditional clinical trial phases such as 1, 2 and 3 for promising new therapies, and we believe Kevetrin fits that mold as an activator of p53. We are privileged to have the experts at Dana-Farber, Beth Israel Deaconess, and partners conducting the research that is helping us chart a course to try and capitalize on this shifting regulatory trend by meticulously defining which cancer tumor types may be most beneficially impacted by Kevetrin.”
With 40 patients enrolled, Cellceutix feels that it has more than ample data supporting the safety of Kevetrin as well as evidence of possible therapeutic benefits. As such, the Company is moving forward with confidence in preparing documentation for a meeting with the Food and Drug Administration seeking to initiate a Phase 2/3 trial of Kevetrin against a specific type of cancer.