Cellceutix Files Amended IND With FDA for Its Novel p53 "Guardian Angel" Anti-Cancer Drug
(firmenpresse) - BEVERLY, MA -- (Marketwire) -- 05/21/12 -- Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company developing a novel drug to treat cancers and cancers which have proven resistant to today's cancer therapies (drug-resistant cancers), is pleased to announce that its amended Investigational New Drug ("IND") application for Kevetrin™ has been submitted to the U.S. Food and Drug Administration ("FDA") today. As previously disclosed, the planned Phase 1 clinical trial for this pioneering drug is to take place at the Harvard Cancer Center in Boston.
Per standard protocol, the FDA now has 30 calendar days to review and present any questions related to the IND before the Company can initiate the commencement of the clinical trial. The clinical trial will test Kevetrin against a variety of cancer types in patients with advanced-stage cancers. Primary endpoints for the study will be safety and tolerable dosing levels for a future Phase 2 clinical trial.
Cellceutix consultant Dr. Sylvia Holden commented, "I have been researching new drugs for nearly 30 years. Cellceutix is now a true pioneer in oncology discovery with this very special compound, Kevetrin. The Mechanism of Action of Kevetrin™, impacting both wild and mutant types of p53 to induce apoptosis and cell cycle arrest through multiple pathways while being well-tolerated, is what sets it apart from other chemotherapies today. Rather than being a traditional drug that targets and attempts to seek and destroy cancer cells independently, Kevetrin™ revitalizes p53 so that the body's natural defense system eliminates the tumor on its own. As a stand-alone or combination front-line therapy, the magnitude of the potential of Kevetrin™ is simply unparalleled by anything that I have ever seen in the laboratory before."
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix commented, "I will be attending the American Society of Clinical Oncology ("ASCO") Meeting in June to continue discussions regarding Kevetrin™. We anticipate that next year we will be presenting data from this year's planned clinical trials."
Dr. Holden received her PhD from Boston University followed by an NIH-funded post-doctoral fellowship at Dana-Farber Cancer Institute in the Division of Cancer Pharmacology headed by chemotherapy pioneer and Cellceutix Scientific Advisor Dr. Emil Frei III. Before joining Cellceutix, Dr. Holden was the Director of Pharmacology at EMD Serono in Billerica, MA (Merck KGaA) and Director of Tumor Biology at Shionogi BioResearch Corp., in Lexington, MA (presently Synta Pharmaceuticals). She was awarded 5 US patents and has published over 100 publications in peer-reviewed journals, including 12 first-authored papers and publications in Science and Nature Medicine.
As a completely new class of chemistry, 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, 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.
About Cellceutix
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 .
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
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Datum: 21.05.2012 - 07:10 Uhr
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