Company Begins Discussions With One of the World’s Leading Cancer Centers for the Expected Phase 1 Trials
BEVERLY, MA–(Marketwire – September 28, 2010) – Cellceutix Corporation (PINKSHEETS: CTIX) today announced that it has completed its first species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This study is required for an Investigational New Drug (IND) filing. In the study, rats were administered five doses of Kevetrin ™ weekly over a 29 day period. Three groups of 20 animals were administered 60 mg/kg, 90 mg/kg and 120 mg/kg respectively while a fourth group acted as controls. There was a 14 day recovery period after the dosing. Parameters measured were hematology, clinical chemistries, weight change, food consumption, survival, and pathology.
“We are now completing a similar study in the second tier of animals as required by the FDA,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”At Cellceutix we are very excited about the progression of Kevetrin as we are right on course with our business plan to develop it as a treatment for cancers that are resistant to standard therapies.”
In animal studies, Kevetrin was found to significantly delay tumor growth in multi-drug resistant lung, breast and colon cancer cell lines. In data presented in April, 2010 at the American Association for Cancer Research, the efficacy of Kevetrin in a mouse model of drug resistant lung cancer was shown to increase with increasing dose. The data presented at the AACR also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance.
“The toxicity studies are on the critical path for our IND filing,” said George Evans, CEO of Cellceutix. ”The final FDA required studies necessary to begin human trials are near completion, after which we will be able to file our IND. The Company has begun discussions with clinical investigators at one of the world’s leading cancer centers for the expected Phase 1 trials.”