Cellceutix Makes Breakthrough in Cancer Research by Activating p53, the "Guardian Angel of the Human Genome"

Cellceutix Corporation has announced that data from research on Kevetrin™, the Company's flagship compound against cancers, has demonstrated the potential for a major breakthrough in cancer research by exhibiting an activation of p53.

p53, often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome" due its crucial role in controlling cell mutations, is a tumor suppressor protein that is encoded by the TP53 gene in humans and has been widely regarded as possibly holding a key to the future of cancer therapies.

p53 has been shown to play critical roles in the homeostatic health of the human body by activating proteins required to repair DNA and plays a major role in the life cycle of cells by inducing cell cycle arrest and apoptosis to maintain cellular and genetic stability.

In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components.

This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.

Dr. Ashok Kumar, a consultant to Cellceutix, discovered this function while researching Kevetrin's Method of Action (MOA). Dr. Kumar is a highly regarded Molecular Biologist who received his Ph.D. from Jawaharlal Nehru University, one of the most prestigious schools in India.

He has been awarded a Japan Society of Promotion of Sciences fellowship from the Government of Japan and has been published extensively in top scientific journals in the area of Immunology and Molecular Biology. From 2001-2010 he was a faculty member in the Dept. of Immunology, Mayo Clinic, Rochester, MN.

Dr. Kumar commented, "The research began with trying to understand why Kevetrin™ was so effective against certain resistant cancers that other drugs can't treat. After a period of extensive testing, the results showed that Kevetrin activates p53 which induces the expression of p21 and acts as inhibitor of cell cycle progression. Activated p53 induces expression of PUMA and initiates apoptosis. In addition to activation of p53, Kevetrin also induces G2 / M phase of the cell cycle arrest by decreasing CDK1 and cdc25 and increasing Wee1 regulatory proteins in the cell." Dr. Kumar continued, "Kevetrin can become the ideal drug against many cancers."

Leo Ehrlich, Chief Executive Officer of Cellceutix, stated, "This is a potentially astounding breakthrough in cancer research and greatly increases the hope that pharmacological activation of p53 will provide a clinical benefit for a wide array of malignancies. Significant resources have been expended by the largest pharmaceutical companies in an attempt to develop an effective drug to activate p53, but to date, it seems, none have succeeded. An approved drug that has the ability to treat drug-resistant lung, breast and colon cancers would be expected to generate billions of dollars in sales. Thus far, Kevetrin has demonstrated that ability in animals and we are eager for human trials to begin."

Mr. Ehrlich continued, "While we are expected to maintain calm and composure, the excitement is clearly evident as to what kind of an impact Kevetrin™ might have on the world of oncology."

Cellceutix is completing formulation production, scheduled for early March 2011, which would produce Kevetrin™ in the dosage form for planned clinical trials. The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in May 2011 with human trials to begin shortly thereafter.