Cellceutix Corp. was pleased to announce this morning its acknowledgement of the many emails, phone calls and letters received regarding KM-391, its novel compound for the treatment of autism. In response to the outcries, Cellceutix has drawn upon its many resources and expedited scheduling of additional pre-clinical studies of the compound with the results to be released in upcoming weeks.
Cellceutix worked with the world-renowned InterEd Faculty of Clinical Research (IFCR) in India to move rapidly in the development of KM-391. The Company’s President and Chief Scientific Officer, Dr. Krishna Menon, as Chancellor of IFCR, was able to request expedited scheduling for the testing of KM-391. The prestigious Cochin University of Science & Technology (CUSAT) agreed and conducted the testing. With the research completed and data undergoing analysis, results will soon be ready for release.
“Through a great collaborative effort between our team at Cellceutix with InterEd and Cochin University, we were able to reduce scheduling time from months to weeks,” stated George Evans, Chief Executive Officer of Cellceutix. “Our years of experience in the industry have provided us with valuable resources that were very supportive in our efforts to respond to the critical need for new autism treatments.”
Cellceutix previously reported that initial testing conducted with KM-391 on a mouse model has provided promising data. In a carefully conducted study, KM-391 was given orally over a three month period to groups of rats at two dosage levels. At each dosage level, KM-391 demonstrated significant improvements in the test animals when compared to both the “no treatment” group and the “active control” (fluoxetine) group on the parameters of brain plasticity, serotonin levels and behavioral function. Because KM-391 is a novel compound and not just a derivative of an existing compound, it has taken the spotlight within the autism community and the focus of many communications to Cellceutix regarding its development.
The company also announced today that it has completed two animal safety pharmacology studies for its cancer compound, Kevetrin™, both of which are required by the U.S. Food and Drug Administration (FDA) prior to filing an Investigational New Drug (IND) application. The studies evaluated the impact of the compound on the respiratory and central nervous systems of test animals. In the respiratory study, respiratory rate, tidal volume and minute volume were measured. In the central nervous system study, neuropharmacological effects and effects on body temperature were measured. A cardiovascular safety pharmacology study is nearing completion.
“The results of these studies are very encouraging for the further development of Kevetrin,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The respiratory and central nervous system studies showed no biologically significant changes compared to controls. Since these studies are required by the FDA for an IND filing, their completion is a major forward step for us.”
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