Cellceutix Completes Lab Testing of Brilacidin for Planned Phase 3 Trial for Acute Bacterial Skin and Skin Structure Infections

BEVERLY, MA--(Marketwired - December 11, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that laboratory testing of Brilacidin has been completed for use in the planned Phase 3 study in Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This lot of Brilacidin API (active pharmaceutical ingredient) has now passed rigorous quality control tests. In addition, development work on lyophilizing Brilacidin has been successfully completed. The engineering run has been completed and the production run is scheduled for this month. This will allow Brilacidin for ABSSSI to be stored at room temperature or under refrigeration, a significant advantage over freezing, as was required in the past.

The Company is now completing all the necessary steps to move Brilacidin for ABSSSI into Phase 3, including working with vendors in selecting international sites for the planned study.

Approximately one year ago, we disclosed, "Cellceutix has signed an agreement with a division of one of the largest U.S. pharmaceutical companies for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. This potential prophylactic use was not part of Cellceutix's strategic plans for Brilacidin, but given the compilation of clinical and laboratory data, it is a logical application that could potentially add millions of dollars of revenue to the Company. The material transfer does not cover the pharmaceutical use of Brilacidin for treatment of infections or other diseases. A final contract can only be entered into if and when Brilacidin receives Food and Drug Administration (FDA) approval." We are pleased to report that this pharmaceutical company recently ordered additional Brilacidin for further testing. We interpret this as a positive sign and remain optimistic about this application for Brilacidin.

Although other companies have announced plans to enter the ABSSSI market, we believe their intention for doing such is primarily to use ABSSSI as a gateway for treating other diseases. When comparing their drug to approved ABSSSI drugs, we believe they are uncompetitive due to dosing regimens and other factors. However, at Cellceutix we view ABSSSI as a huge commercial opportunity for Brilacidin, possibly as much as hundreds of millions of dollars per annum for an approved single dose treatment, as well as a gateway to other diseases.