SOURCE: Cellceutix

December 22, 2014 07:00 ET

Cellceutix Reports Positive Results of Brilacidin in Microbiological Intent-to-Treat Population in Phase 2b ABSSSI Trial; Additional Pharmacokinetic Information to Be Submitted

Company Also Reports IRB Approval to Start Oral Mucositis Trial, Grant Awarded for HDP Mimics and Biotech Showcase on Tap

BEVERLY, MA--(Marketwired - Dec 22, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to provide additional information from the Company's recently completed Phase 2b clinical trial of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI), as well as information on other pipeline developments.

On October 23rd 2014, Cellceutix announced positive top-line results for the randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of ABSSSI. The primary endpoint, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, was achieved in the intent-to-treat (ITT) population at 48-72 hours, for each of the three Brilacidin dosing regimens, including two single-dose regimens, with results that were comparable to the FDA-approved seven-day dosing regimen of daptomycin.

Cellceutix has continued to analyze the data within other populations in the study in addition to the intent-to-treat population. The Company is pleased to report that the results are also positive in the Microbiological Intent-to-Treat population (MITT). This is an important population, as it consists of patients enrolled in the trial who had cultures obtained at the baseline visit that were positive for common ABSSSI pathogens. Most of these cultures grew Staphylococcus aureus, and approximately 40% of these were Methicillin-Resistant Staphylococcus aureus (MRSA). This is currently the most important bacterial pathogen in patients with ABSSSI. As was seen in the ITT population, the primary endpoint in the patients with culture-positive ABSSSI was achieved for each of the three Brilacidin dosing regimens with similar results as for treatment with daptomycin for seven days.

In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained pharmacokinetic (PK) data. The Company has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, the Company will meet with the FDA to discuss the completed Phase 2b study and to discuss the plans for Phase 3 studies.

Oral Mucositis- Institutional Review Board (IRB) Approval

Cellceutix has received Institutional Review Board (IRB) approval to initiate its Phase 2 study of Brilacidin-OM, the Company's novel oral rinse for the prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer. Study sites identified in the U.S. include MD Anderson Cancer Center at the University of Texas. A description of the study has now been submitted to and is expected to be published in the near term. In the U.S., no treatment is approved by the FDA to prevent the often debilitating condition of oral mucositis, the inflammation and ulceration that occurs in the mouth and affects the majority of patients who undergo chemoradiation.

$565,440 Grant Awarded for Research on Cellceutix Platform Technology

A key Cellceutix collaborator, Fox Chase Chemical Diversity Center, has received a 1-year extension on a subcontract from the University of Massachusetts (Amherst) under a UO1 National Institute of Health grant. The subcontract of $565,440 will be used to continue research on the development of the Cellceutix platform technology of host defense protein mimics (HDP mimics or defensin-mimetics) to combat serious and life-threatening infections caused by multi-drug resistant Gram-negative bacteria. The target pathogens include multi-drug resistant Acinetobacter baumannii, Pseudomonas aeruginosa and the carbapenem-resistant Enterobacteriaceae (CRE) Klebsiella pneumoniae and Escherichia coli. Initial research will focus on continuing the development of lead compounds active against CRE organisms, including CTIX 1807, which has shown robust activity against Klebsiella pneumoniae in a mouse tissue infection model.

Biotech Showcase: Kevetrin and Prurisol

Cellceutix will be updating shareholders on the latest developments of the Kevetrin clinical trials for solid tumors ongoing at Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center and the upcoming trial of Kevetrin for Acute Myeloid Leukemia (AML) being sponsored by the University of Bologna and its partners during the Biotech Showcase conference being held in San Francisco on January 12, 2015. Updates on the Company's Phase 2 trial of Prurisol (abacavir acetate) for plaque psoriasis will also be provided at the conference.

New IND filing planned

Cellceutix is preparing a request for a pre-IND meeting with the FDA to discuss clinical development plans to evaluate a Cellceutix defensin-mimetic for the treatment of serious gastrointestinal diseases. Updates on this important development will also be provided at Biotech Showcase.

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 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 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

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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