BEVERLY, MA--(Marketwired - February 10, 2016) - Cellceutix Corporation (CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that Cellceutix executives met this week with staff of the FDA Division of Oncology Products 1 to discuss the Kevetrin Phase 1 study data, as well as a proposed design of a planned Phase 2 trial in patients with ovarian cancer that have resistance to platinum-based therapy.
The FDA has agreed with Cellceutix’s plan to initiate such a trial, and based upon the data from the Phase 1 trial, that the administration of Kevetrin doses at three times per week would be acceptable. The FDA provided excellent guidance regarding several aspects of the planned protocol, including the proposed trial endpoints and insights regarding drugs to be used in combination with Kevetrin. Cellceutix will release additional information on these details when appropriate.
The phase 1 trial of Kevetrin trial yielded exciting data validating the safety of Kevetrin and suggestive evidence of the potential clinical benefit of Cellceutix’s novel p53-targeting compound in patients who had relapsed after other cancer treatments. Because of the relatively short half-life of Kevetrin in plasma, it is the Company’s belief that administering Kevetrin multiple times per week may have a clinical benefit in the planned Phase 2 trial in patients with ovarian cancer. The meeting with the FDA was very productive, as their guidance was forward- thinking and quite helpful as Kevetrin advances on its clinical pathway.
Cellceutix is developing Kevetrin under an Orphan Drug designation for ovarian cancer from the U.S. Food and Drug Administration (FDA).
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About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships.
Cellceutix’s anti-cancer drug Kevetrin is concluding a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its application for a Phase 2 study. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin.
Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
