Cellceutix Reports In Vivo Tumor Shrinkage in Renal Cancer
BEVERLY, MA – January 24, 2013– 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 received results from in vivo studies conducted at Beth Israel Deaconess Medical Center (“BIDMC”). Cellceutix had earlier reported that they entered into an agreement with BIDMC, a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin™, the Company’s flagship anti-cancer drug. BIDMC wishes to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy.
Research by BIDMC combined Kevetrin™ with sunitinib on cell line 786, a drug-resistant renal cancer. Cellceutix was advised by the researchers that “the Kevetrin/sunitinib combination is the first we’ve used in which actual tumor shrinkage is noted.”
Per protocol, Cellceutix has formally notified BIDMC that it has a strong interest in further collaborative efforts to develop combination treatments with Kevetrin and multikinase VEGF receptor antagonists, particularly VEGFR2 inhibitors. Cellceutix has provided the requested information that will be used to investigate a Specialized Programs of Research Excellence (SPORE) grant for a phase 2 clinical study.
Renal cell carcinoma is the most common type of kidney cancer in adults. BIDMC is the lead recipient of the prestigious National Cancer Institute-funded kidney cancer SPORE grant.
In 1992, the National Cancer Institute (NCI) established the Specialized Programs of Research Excellence (SPOREs), specialized cancer center grants to promote and speed up the exchange between interdisciplinary research in the laboratory to the treatment of patients in the clinical care setting.
SPORE programs allow laboratory and clinical scientists to work collaboratively to plan, design, and implement research programs with the greatest potential to impact cancer prevention, detection, diagnosis and treatment.
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.
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
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
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