BEVERLY, MA -- (Marketwire) -- 07/16/12 -- Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, reports today that it has been conducting meetings with manufacturers to synthesize and formulate its lead psoriasis drug, Prurisol, for a Phase 2/3 clinical trial. The U.S. Food and Drug Administration ("FDA") recently told Cellceutix that an application for a 505(b)(2) designation for Prurisol would be an acceptable approach; allowing the Company to advance Prurisol immediately into advanced stages of clinical trials. Additionally, the Company is pleased to report that the Site Initiation Visit ("SIV") for its flagship anti-cancer compound, Kevetrin, will happen this week at Harvard Cancer Center to prepare researchers for the commencement of clinical trials at Harvard's Dana-Farber Cancer Center and partner Beth Israel Deaconess Hospital.
"We have conducted multiple meetings with companies to manufacture Prurisol and are aligning our strategies to advance the drug candidate into human trials as expeditiously and efficiently as possible," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Our confidence is high for Prurisol and we are systematically deciding the best procedures going forward with it to maximize outcomes and shareholder value."
Leo Ehrlich, Chief Executive Officer at Cellceutix, added, "All of the documentation and requirements to begin the clinical trials of Kevetrin are now in place. The SIV visit this week is the final step before we will begin the patient enrollment process. This is where the rubber meets the road for Cellceutix and I am extremely excited for the possibilities of both Kevetrin as a novel drug that could potentially reshape the landscape of cancer therapies, and Prurisol, a new drug that significantly outperformed a standard care for the treatment of psoriasis in our lab studies. Our offices receive many correspondences on these two compounds and we will continue to do our very best to keep shareholders informed about ongoing developments."
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.
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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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.