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Company beginning process to move to national securities exchange
Beverly, MA— August 12, 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 is on track to commence a clinical study for its anti-psoriasis drug Prurisol™. The Company has completed and submitted all regulatory documents necessary for the clinical study and anticipates receiving the regulatory documents this week allowing for the importation of Prurisol™ into Europe to begin the clinical study.
“We are pleased to inform shareholders that we have now completed the regulatory matters necessary for a clinical study of Prurisol and that we have been notified by our contract manufacturer, Dr. Reddy’s Laboratories (RDY), that Prurisol is ready for shipping to the clinical site,” Leo Ehrlich, CEO at Cellceutix stated. “We are planning to have the drug shipped in August and the trial to commence shortly thereafter. The clinical site has been notified to begin patient recruitment. We are optimistic about the potential for Prurisol™ to reproduce the laboratory results which showed the drug to effectively eliminate all signs of psoriasis.”
In other news, Cellceutix’s clinical trial of its anti-cancer drug Kevetrin™ is progressing and is presently in the dose escalation phase as maximum tolerated dose (MTD) has not yet been reached. The testing for p21, a biomarker study at the Harvard Cancer Center lab has not yet begun. Dr. Krishna Menon, Cellceutix’s Chief Scientific Officer commented, “We understand that there were internal priorities at the lab and because these are very sophisticated and complex tests, the process can be detailed and somewhat time consuming. We are hopeful that these important biomarker studies will soon be processed and when they are, we will share those results.”
The Company is also pleased to report that it is currently planning to uplist (moving from an over-the-counter stock to a national securities exchange like NASDAQ-CM or NYSE-MKT). “Due to the Company’s strong financial backing from our $10 million equity line from Aspire Capital, and further progress in our clinical trials, we are intending to move to a senior exchange,” commented Leo Ehrlich, CEO. “Over the coming weeks we will be interviewing for the positions of independent directors to meet the requirements for an uplisting which we hope will increase liquidity and unlock inherent value in our stock. We will be presenting at the Rodman and Renshaw Annual Global Investment Conference in September where we will discuss in detail the Company’s progress, growth objectives and plans for 2013- 2014.”
About Kevetrin™
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 here.
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 www.cellceutix.com.
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.