Cellceutix Reports Positive Results of Brilacidin in Microbiological Intent-to-Treat Population in Phase 2b ABSSSI Trial

Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceuticalcompany developing innovative therapies with oncology, dermatology,and antimicrobial applications, is pleased to provide additional information from the Company's recently completed Phase 2b clinicaltrial of Brilacidin for the treatment of Acute Bacterial Skin andSkin Structure Infections (ABSSSI), as well as information on other pipeline developments.On October 23rd 2014, Cellceutix announced positive top-line resultsfor the randomized double-blind study comparing three dosing regimensof Brilacidin to daptomycin for the treatment of ABSSSI. The primary endpoint, defined as reduction of at least 20% in area of ABSSSIlesion, relative to baseline, was achieved in the intent-to-treat(ITT) population at 48-72 hours, for each of the three Brilacidindosing regimens, including two single-dose regimens, with resultsthat were comparable to the FDA-approved seven-day dosing regimen of daptomycin.Cellceutix has continued to analyze the data within other populationsin the study in addition to the intent-to-treat population. TheCompany is pleased to report that the results are also positive inthe Microbiological Intent-to-Treat population (MITT). This is an important population, as it consists of patients enrolled in thetrial who had cultures obtained at the baseline visit that werepositive for common ABSSSI pathogens. Most of these cultures grew Staphylococcus aureus, and approximately 40% of these were Methicillin-Resistant Staphylococcus aureus (MRSA). This is currentlythe 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 daptomycinfor seven days.In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, includinganalyses of the recently obtained pharmacokinetic (PK) data. TheCompany has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, theCompany will meet with the FDA to discuss the completed Phase 2bstudy and to discuss the plans for Phase 3 studies.Oral Mucositis- Institutional Review Board (IRB) ApprovalCellceutix 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 beensubmitted to www.clinicaltrials.gov and is expected to be publishedin 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 TechnologyA key Cellceutix collaborator, Fox Chase Chemical Diversity Center,has received a 1-year extension on a subcontract from the Universityof Massachusetts (Amherst) under a UO1 National Institute of Health grant. The subcontract of $565,440 will be used to continue researchon the development of the Cellceutix platform technology of hostdefense protein mimics (HDP mimics or defensin-mimetics) to combat serious and life-threatening infections caused by multi-drugresistant Gram-negative bacteria. The target pathogens includemulti-drug resistant Acinetobacter baumannii, Pseudomonas aeruginosaand 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 activityagainst Klebsiella pneumoniae in a mouse tissue infection model.Biotech Showcase: Kevetrin and PrurisolCellceutix will be updating shareholders on the latest developmentsof the Kevetrin clinical trials for solid tumors ongoing at DanaFarber Cancer Institute and Beth Israel Deaconess Medical Center andthe 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 January12, 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 plannedCellceutix is preparing a request for a pre-IND meeting with the FDAto discuss clinical development plans to evaluate a Cellceutix defensin-mimetic for the treatment of serious gastrointestinaldiseases. Updates on this important development will also be providedat Biotech Showcase.