BEVERLY, MA -- (Marketwire) -- 02/04/13 -- 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, today announces that the Company is submitting an abstract for the upcoming 2013 American Society of Clinical Oncology ("ASCO") Annual Meeting to be held in Chicago, Illinois on May 31 to June 4. The presentation is entitled: "A Phase 1 Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic Study of Thioureidobutyronitrile (Kevetrin), a Novel p53 Targeted Therapy in Patients with Advanced Solid Tumors."
Key personnel, including investigators and physicians from the hospitals involved in the clinical trials of Kevetrin, Cellceutix's flagship anti-cancer compound being hosted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, assisted in preparing the abstract.
The ASCO meeting gives Cellceutix an opportunity to provide a comprehensive update on the latest data from the Kevetrin clinical trials to shareholders and leaders in the scientific community as well as time for interaction with others about possible future collaborations and studies. Furthermore, it showcases Cellceutix's novel drug and accomplishments to many of the organizations that were first introduced to Kevetrin three years ago when it was recognized at the American Association for Cancer Research as a drug on the 'frontier' of cancer research.
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented, "We are still at the early stages of the clinical trial. To date, we have not observed any dose limiting toxicities. Initial pharmacokinetic (PK) data from the clinical trial has been received and is consistent with the animal data, which is a very optimistic sign moving forward. Additional information on these PK studies will be forthcoming at ASCO. We are now looking forward to receiving data from the p21 biomarker studies which is expected in March 2013."
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
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.
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