Beverly, MA — 06/26/13 — Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, announces today that the Company has signed a Material Transfer Agreement (MTA) with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”). Per the MTA, Cellceutix will provide MD Anderson with Kevetrin, the Company’s novel anti-cancer drug candidate, for laboratory research of Kevetrin as a potential new treatment for Lymphoma and Multiple Myeloma.
MD Anderson intends to utilize in vivo and in vitro methods to research specific pathways, gene expression, mechanism of action and apoptotic activity of Kevetrin in a range of concentrations and time points in both mutant and wild-type p53 Myeloma and Lymphoma cell lines. Research is also planned to evaluate Kevetrin against models of Multiple Myeloma cell lines that are resistant to bortezomib, lenalidomide and other FDA-approved chemotherapies. Additional studies will be conducted evaluating the anti-tumor activity of Kevetrin when used as a combination therapy with several FDA-approved drugs. MD Anderson will provide funding for these studies of Kevetrin defined by the MTA.
“This is another significant development in our advancement of Kevetrin. We are thrilled by the collaboration and MD Anderson’s interest in researching Kevetrin as a potential new drug for Multiple Myeloma and Lymphoma,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “Currently moving through clinical trials for solid tumors at Harvard’s Dana-Farber Cancer Center, Kevetrin being evaluated for blood cancers at MD Anderson puts our novel drug in the hands of innovative and experienced scientists at two of the most prestigious cancer research centers in the world, bar none. MD Anderson has defined a robust course of study that will provide invaluable insight to the anti-tumor activity of Kevetrin that will be used to plan for additional clinical trials as we continue to execute our strategy to aim Kevetrin at a broad spectrum of cancer lines.”
About MD Anderson
Employing more than 19,000 people caring for more than 110,000 cancer patients in 2012, the mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public. From 2001 through 2012, MD Anderson has ranked No. 1 in cancer care in the “Best Hospitals” survey published in U.S. News & World Report, in addition to many other accolades.
Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). It is also called Kahler disease, multiple myeloma, myelomatosis, and plasma cell myeloma. The National Cancer Institute estimates that there will be 22,350 new cases of myeloma diagnosed in 2013 in the United States and that there will be 10,710 deaths from the disease. Myeloma constitutes approximately one percent of all cancers in the United States.
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
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.
Further information on the clinical trial, titled “A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors,” is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1