BEVERLY, MA–(Marketwire – October 28, 2010) – Cellceutix Corporation (PINKSHEETS: CTIX) today announced that it has completed its second and final species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This is the last safety study required for an Investigational New Drug (IND) filing. In the study, animals were administered five doses of Kevetrin™ weekly over a 29 day period. Three groups of 14 animals were administered 5 mg/kg, 25 mg/kg and 60 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, urinalysis, ophthalmic examination and histopathology. This study, as well as the earlier toxicity and safety pharmacology studies, were performed by Toxikon, in Bedford, Massachusetts.
“This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies.”
“This is an extraordinary milestone for a young company like ours,” said George Evans, CEO of Cellceutix. ”We would like to acknowledge our partner for these studies, Toxikon Corporation, who provided us with high quality work and excellent customer service. We believe we are now well on our way to an IND filing later this year or early next.”
“We are proud to have led these important toxicology studies and help Cellceutix achieve its goal of getting Kevetrin to human trials and, ultimately, to market,” said Dr. Laxman Desai, president and CEO of Toxikon, adding that “Toxikon is equipped to meet the industry’s anticancer and antiviral drug discovery demands.”