BEVERLY, MA–(Marketwired – Nov 11, 2014) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antibiotic applications, is pleased to report that enrollment of the first patient in the Company’s Phase 2 clinical trial of Brilacidin-OM for oral mucositis, an often debilitating effect of certain cancer therapies, is targeted for December 2014. Procedural work is being conducted at University of Texas MD Anderson Cancer Center as well as other clinical sites participating in the study. Cellceutix will soon be updating www.clinicaltrials.gov to reflect the start of the trial.
Regarding other drugs in development in the Cellceutix pipeline, meetings have been scheduled with the U.S. Food and Drug Administration (FDA) to advance the clinical development of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Prurisol for treatment of psoriasis.
In October, Cellceutix released positive top-line data from a Phase 2b trial of Brilacidin for ABSSSI showing that a one day dosing of Brilacidin had similar efficacy as seven (7) days of treatment with daptomycin. After discussion with FDA later this year, Cellceutix plans to disclose additional information regarding the Phase 2b trial results. Cellceutix believes Brilacidin has the ability to be the “First in Class” treatment for ABSSSI should Phase 3 clinical trials confirm the current findings.
In June, Cellceutix successfully completed a Phase 1 trial to confirm safety and pharmacokinetics of Purisol as precursor to initiate a Phase 2/3 study in patients with psoriasis. A meeting is scheduled with the FDA in December 2014 to discuss the planned Phase 2/3 protocol.
Cellceutix has also recently been informed of additional research data from the Company’s Phase 1 trial of Kevetrin for solid tumors being conducted at Harvard’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The trial is currently enrolling patients in the ninth cohort. Preliminary data show that 50 percent of patients treated with Kevetrin through the eighth cohort demonstrated enhancement in p21 expression in peripheral blood cells, and that these observations appeared dose-related. The biomarker p21 is tightly controlled by the tumor suppressor protein p53, which is often referred to as the “Guardian Angel Gene” because of its crucial role in controlling cell mutations. Initial comparisons between early and latter cohorts support Cellceutix’s expectations that p53 activation is dependent on extent of exposure to Kevetrin. These results support the hypothesis that Kevetrin has pharmacological activity in patients.
Kevetrin continues to be generally well-tolerated with no evidence of hematologic toxicity. One patient who received the highest dose of Kevetrin administered (350 mg/m2) experienced a dose-limiting toxicity (DLT). At the request of the patient and approval by the physician, the patient continues on the study, but at a reduced Kevetrin dose with no further DLT events. A maximum tolerated dose (MTD) has not been determined in this trial, to date.
“The recent spate of information that we have received concerning our drugs in development is extremely encouraging across the board and sets the stage for a great start to 2015,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. ”We look forward to the initiation of the Brilacidin-OM trial. The results of the Brilacidin Phase 2b study in ABSSSI trial provides us with even greater confidence that we have an incredible drug at the center of our defensin-mimetic platform technology.”
Mr. Ehrlich continued, “The latest data from the Kevetrin trial is on par with our expectations all along, suggesting Kevetrin is capable of activating p53. We believe we are nearing the conclusion of this first Kevetrin trial, but we still have some decisions to make, which could include another cohort to confirm our findings on Kevetrin and assist in planning for future studies. With all the excitement surrounding Brilacidin and Kevetrin, it seems that the potential of Prurisol may be overlooked, but certainly not by us. We are eager to meet with the FDA next month to discuss the path forward to hopefully establish the efficacy of Prurisol in this chronic condition.”