Cellceutix Provides Initial Observations of Completed ABSSSI Phase 2b Trial; Company Submits Investigational New Drug Application to FDA for Phase 2 Trial of Brilacidin-OM for Oral Mucositis - Seite 2

Cellceutix is also pleased to announce the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") to commence a Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis.

Oral mucositis is a common and often debilitating inflammation and ulceration in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy that affects nearly half a million people each year. Laboratory studies of Brilacidin-OM have demonstrated antibacterial, anti-biofilm and anti-inflammatory properties of Brilacidin-OM as an oral rinse that significantly reduced the duration of oral mucositis by 90 percent or more. There are currently no FDA-approved preventative or therapeutic drugs to treat oral mucositis induced by a broad spectrum of cancer therapies.

"Oral mucositis is an extremely painful condition that often goes overlooked and unpublicized as a side effect for treating hundreds of thousands of cancer patients," commented Leo Ehrlich Chief Executive Officer of Cellceutix. "There is a tremendous market opportunity to treat this condition as it pertains to cancer, as well as in the emerging field of stem cell transplantation. We have a great deal of confidence in initiating this Phase 2 trial and hope this will lead to a drug that offers oral mucositis patients a viable treatment for their discomfort."

Regarding Kevetrin, Cellceutix's lead anti-cancer compound in a dose escalation Phase 1 clinical trial, no drug-related serious adverse events or significant laboratory changes were reported in the eighth cohort in which patients were treated with 215 mg/m2 of Kevetrin. The safety committee yesterday determined that the next 9^th cohort may be treated with 350 mg/m2. Patient dosing is scheduled to begin this week.

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 has submitted an IND to the FDA for its planned 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 enrollment in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than most currently marketed antibiotics 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.