SOURCE: Cellceutix

January 22, 2015 07:00 ET

Cellceutix Phase 2b Clinical Trial of Brilacidin Accepted for Oral Presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

Company to Give Three Presentations Highlighting Its Novel Antibiotics

BEVERLY, MA--(Marketwired - Jan 22, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed phase 2b clinical trial "A Randomized, Double-Blind Study Comparing Single-Dose and Short-Course Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin & Skin Structure Infections (ABSSSI)" will be given in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held in Copenhagen, Denmark from April 25-28, 2015. ECCMID is one of the largest annual gatherings of infectious disease experts in the world, and an ideal forum to present the results of a clinical trial. Dr. Daniel Jorgensen, Cellceutix's Chief Medical Officer, will give the presentation during a session entitled "New Antibacterial Agents - Phase 2 and Phase 3 Clinical Trials."

"We worked with the FDA in designing the recent phase 2b study," said Dr. Jorgensen. "As predicted, a lower total dose of Brilacidin, given as a single-dose regimen, was well tolerated and efficacy was comparable to that of the 7-day regimen of the active control, daptomycin."

"It's important to note that a single-dose regimen has benefits beyond safety and efficacy," Dr. Jorgensen added. "It can maximize patient compliance and thereby reduce the potential for the development of antibiotic resistance. Of course, Brilacidin's unique mechanism of action to penetrate the bacterial cell wall to eradicate bacteria is another reason why resistance is unlikely to develop. Further, Brilacidin has anti-inflammatory and anti-biofilm properties. When considering all these factors, Brilacidin has the potential to transform the way we treat infectious diseases."

In addition to the clinical data from the ABSSSI trial, Cellceutix will also present important preclinical data. The abstract entitled Synthetic Novel Host Defense Protein Mimetics for the Treatment of Gram-Negative Bacterial Infections has been accepted for oral presentation in the session entitled Drug Discovery. "This is an opportunity for experts to hear about the other promising defensin-mimetics -- not just Brilacidin," said Dr. Jorgensen. "These compounds have potential to treat serious Gram-negative infections, including those identified by CDC as 'antibiotic resistance threats.' "

The final presentation, a poster entitled Brilacidin, Host Defense Peptide Mimetic, One of a New Class of Immunomodulatory Agents that can Target Multiple Disease Indications, will be given in the category of New Antimicrobials. "This is an important poster, as it highlights the immunomodulatory properties of Brilacidin, in addition to its antimicrobial properties," Dr. Jorgensen added. "These animal data support the use of topical Brilacidin in humans to prevent or ameliorate oral mucositis, a painful condition in cancer patients undergoing chemoradiation therapy. A phase 2 clinical trial is about to begin."

Dr. Jorgensen concluded, "There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need and that these compounds will also play an important role in the management of inflammatory diseases of the skin and mucous membranes. The laboratory and clinical data we have collected to date support the exciting promise of this class of compounds. We look forward to sharing these data at the ECCMID meeting."

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 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.

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