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BEVERLY, MA--(Marketwired - June 03, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to provide shareholders insight to our presentation of certain clinical data at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago that concluded on Tuesday, June 2, 2015.
Cellceutix's poster provided an overview of the Company's ongoing Phase 1 clinical trial to evaluate the safety and preliminary efficacy of Kevetrin as a monotherapy (single-agent treatment) for patients with advanced solid tumors. The study has demonstrated the safety of Kevetrin administration over repeated cycles. In addition, increases in p21 expression were shown in a number of the patients in multiple cancers and p21 activity appears to be dose related. Cellceutix showed that Kevetrin may become an important therapy in the treatment of gynecological cancers/ovarian cancers.
The poster was visited by industry and academia, including key opinion leaders, representatives of large and small pharmaceutical companies, leading universities, foundations and leading international cancer scientists interested in information on Kevetrin and its ability to act upon p53, an important therapeutic target in oncology as a master regulator of the cell cycle.
Cellceutix is developing Kevetrin as a monotherapy due to its unique mechanism of action to help restore p53 function. The objective of the therapy is to trigger the natural responses of apoptosis, or programmed cell death, and cell cycle arrest. Combined with its favorable safety and pharmacokinetic profile, Kevetrin is a strong candidate not only as a potential stand-alone therapy, but also in combination with other treatments, including immunotherapies, as part of the next generation in cancer care.
"The Cellceutix poster at ASCO brought great interest to Kevetrin with data suggesting that Kevetrin can reactivate p53 with very limited toxicity as a front-line treatment for cancer," stated Dr. Krishna Menon, Cellceutix Chief Scientific Officer. "Although the framework of the trial and ASCO guidelines prevented us from disclosing certain information, these experienced scientists took note of the gynecological cancer patients in the trial and extrapolated the data to pose many questions. Several companies and institutions wanted to discuss the possibility of Kevetrin in combination with their drugs or therapies to potentially increase efficacy and reduce or avoid side effects in a variety of cancers, including some rare, hard-to-treat and pediatric cancers. This is akin to the Kevetrin and sunitinib combination tested in a renal cancer line that generated very optimistic results. Kevetrin will continue to be developed in collaborations to become the compound of choice for the treatment of many cancers."
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Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix has begun a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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