BEVERLY, MA--(Marketwired - September 08, 2015) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that it will be concluding its Phase 1 trial of the novel compound Kevetrin in patients with advanced solid tumors at the completion of the current cohort. The final cohort requires that six patients be treated at the maximum tolerated dose. Three of the six patients in the cohort have already completed the required treatments with Kevetrin. Cellceutix has been advised that the remaining three patients are currently being recruited.
In July, Cellceutix received an Orphan Drug designation for Kevetrin for the treatment of ovarian cancer from the U.S. Food and Drug Administration. Ovarian cancer is usually treated with platinum-based therapies where resistance develops quickly. The soon-to-be completed Phase 1 trial has provided robust data on the safety of Kevetrin treatment and compelling data with respect to ovarian cancer, some of which has already been publicly disclosed by Cellceutix. The conclusion of the trial fits with the Company's strategic plan to initiate a Phase 2 trial of Kevetrin for ovarian cancer, a notoriously difficult disease to treat and a great area of unmet medical need in a major cancer market. The protocol for the next study is currently being written, with preliminary plans for the trial to be a multi-arm study evaluating Kevetrin as a monotherapy and as a component of combination therapy.
"I am encouraged and excited about the clinical direction of Kevetrin, as I believe ovarian cancer represents one of the fastest paths to potential approval," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "With the conclusion of the Phase 1 trial, clinical development of Kevetrin is going to greatly expand and accelerate as we aim to realize the full potential of this p53-targeting compound."
Cellceutix also wishes to inform shareholders that it is preparing a proxy statement to be filed with the Securities and Exchange Commission for the Company's first Annual General Meeting of Shareholders. More details are to follow.
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Cellceutix clinical trials on Clinicaltrials.gov:
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 is in 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 is in 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.