Cellceutix Cop. is a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease. The company announced today that it has completed a successful pre-investigational new drug exemption (pre-IND) meeting with the US Food and Drug Administration (FDA) for its lead compound, Kevetrin, which is being developed to treat drug resistant cancers.
The company has the remaining pre-IND animal studies for Kevetrin underway. These studies consist of intermediate-term toxicity studies in two species and safety pharmacology studies in the cardiovascular, central nervous system and respiratory areas. In these animal studies, Kevetrin was found to significantly delay tumor growth in two multi-drug resistant lung cancer cell lines.
In two experiments with the NCI-H1975 lung cancer cell line, Kevetrin showed an average tumor growth delay of 149% compared to controls, while paclitaxel delayed tumor growth an average of 72%. In two experiments with the A549 lung cancer cell line, Kevetrin showed an average tumor growth delay of 72% compared to controls, while paclitaxel showed an average tumor growth delay of 6%.
In all of the experiments, the delay in tumor growth for Cellceutix’s Kevetrin-treated animals was significantly greater than in the animals treated with paclitaxel. Kevetrin has also shown promising results in animal studies of resistant breast and colon cancer. The company has incorporated the FDA’s comments into their remaining studies which are underway, after which Cellceutix will be able to go forward with their FDA filing.