Company Has Remaining Pre-IND Animal Studies on Kevetrin™ Underway
BEVERLY, MA–(Marketwire – February 16, 2010) – Cellceutix Corporation (OTCBB: CTIX), a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease, today announced that is has completed a successful pre-Investigational New Drug exemption (pre-IND) meeting with the U.S. 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 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 cell line, Kevetrin showed an average tumor growth delay of 149% compared to controls, while paclitaxel delayed tumor growth an average of 72%. The delay in Kevetrin treated animals was significantly greater than in the animals treated with paclitaxel (p < 0.01). In two experiments with the A549 cell line, Kevetrin showed an average tumor growth delay of 72% compared to controls while paclitaxel showed an average tumor growth delay of 6%. Again, the delay in Kevetrin treated animals was significantly greater than in the animals treated with paclitaxel (p < 0.01). Kevetrin has also shown promising results in animal studies of resistant breast and colon cancer.
“FDA provided some very helpful comments on our study protocols,” said George Evans, CEO of Cellceutix. “We have incorporated their comments and now have the remaining studies underway, after which we will be able to go forward with our IND filing. This would be a very significant milestone for Cellceutix.”