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news.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.
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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).