SOURCE: Cellceutix

November 11, 2014 07:00 ET

Patient Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis Targeted to Begin in December 2014

BEVERLY, MA--(Marketwired - Nov 11, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antibiotic applications, is pleased to report that enrollment of the first patient in the Company's Phase 2 clinical trial of Brilacidin-OM for oral mucositis, an often debilitating effect of certain cancer therapies, is targeted for December 2014. Procedural work is being conducted at University of Texas MD Anderson Cancer Center as well as other clinical sites participating in the study. Cellceutix will soon be updating www.clinicaltrials.gov to reflect the start of the trial.

Regarding other drugs in development in the Cellceutix pipeline, meetings have been scheduled with the U.S. Food and Drug Administration (FDA) to advance the clinical development of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Prurisol for treatment of psoriasis. 

In October, Cellceutix released positive top-line data from a Phase 2b trial of Brilacidin for ABSSSI showing that a one day dosing of Brilacidin had similar efficacy as seven (7) days of treatment with daptomycin. After discussion with FDA later this year, Cellceutix plans to disclose additional information regarding the Phase 2b trial results. Cellceutix believes Brilacidin has the ability to be the "First in Class" treatment for ABSSSI should Phase 3 clinical trials confirm the current findings.

In June, Cellceutix successfully completed a Phase 1 trial to confirm safety and pharmacokinetics of Purisol as precursor to initiate a Phase 2/3 study in patients with psoriasis. A meeting is scheduled with the FDA in December 2014 to discuss the planned Phase 2/3 protocol.

Cellceutix has also recently been informed of additional research data from the Company's Phase 1 trial of Kevetrin for solid tumors being conducted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The trial is currently enrolling patients in the ninth cohort. Preliminary data show that 50 percent of patients treated with Kevetrin through the eighth cohort demonstrated enhancement in p21 expression in peripheral blood cells, and that these observations appeared dose-related. The biomarker p21 is tightly controlled by the tumor suppressor protein p53, which is often referred to as the "Guardian Angel Gene" because of its crucial role in controlling cell mutations. Initial comparisons between early and latter cohorts support Cellceutix's expectations that p53 activation is dependent on extent of exposure to Kevetrin. These results support the hypothesis that Kevetrin has pharmacological activity in patients.

Kevetrin continues to be generally well-tolerated with no evidence of hematologic toxicity. One patient who received the highest dose of Kevetrin administered (350 mg/m2) experienced a dose-limiting toxicity (DLT). At the request of the patient and approval by the physician, the patient continues on the study, but at a reduced Kevetrin dose with no further DLT events. A maximum tolerated dose (MTD) has not been determined in this trial, to date. 

"The recent spate of information that we have received concerning our drugs in development is extremely encouraging across the board and sets the stage for a great start to 2015," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We look forward to the initiation of the Brilacidin-OM trial. The results of the Brilacidin Phase 2b study in ABSSSI trial provides us with even greater confidence that we have an incredible drug at the center of our defensin-mimetic platform technology." 

Mr. Ehrlich continued, "The latest data from the Kevetrin trial is on par with our expectations all along, suggesting Kevetrin is capable of activating p53. We believe we are nearing the conclusion of this first Kevetrin trial, but we still have some decisions to make, which could include another cohort to confirm our findings on Kevetrin and assist in planning for future studies. With all the excitement surrounding Brilacidin and Kevetrin, it seems that the potential of Prurisol may be overlooked, but certainly not by us. We are eager to meet with the FDA next month to discuss the path forward to hopefully establish the efficacy of Prurisol in this chronic condition."

About Cellceutix:
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 antibiotic 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 will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory 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 key antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data has shown a single dose of Brilacidin to deliver statistically comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for 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.

Forward-Looking Statements
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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    INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
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