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.

Brilacidin is the first in a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics.   The intravenous formulation of Brilacidin has the potential to treat a variety of infections, including ABSSSI caused by drug-sensitive or drug-resistant strains of Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA), and by other Gram-positive bacteria.

Although several companies are targeting ABSSSI, the Company believes that Brilacidin has several advantages over therapies; these include:

1)    Brilacidin can be given as a single IV dose. At present, there is only one approved drug – and no generics – that can be given a single time for treating ABSSSI.

2) Because it is the first in a new class of antibiotics, there is no expected cross-resistance.  In contrast, all of the newly approved ABSSSI drugs have come from existing classes of antibiotics that have been marketed for years, if not decades.  This means resistance has already developed to older members of that class, and when bacteria are exposed to the new members of the same class, cross-resistance is likely to occur.

3) Brilacidin is effective against the stationary phase of bacteria.  Most bactericidal antibiotics require bacteria to be in an “active growth phase” in order for rapid killing to occur. However, Brilacidin is active against bacteria in both the rapid growth phase and the stationary phase, and it has been shown to disrupt biofilms.  By killing bacteria in both phases, this decreases the opportunity for a “persistent bacteria” to evolve into a “resistant bacteria.”  This is yet another way that Brilacidin could reduce the burden of resistance.

4) Brilacidin has immunomodulatory activity, including anti-inflammatory activity.  This is not surprising, as Brilacidin was created to mimic key properties of our innate immune system. This is the immune system that protects our barriers surfaces, such as skin and mucous membranes. These immunomodulatory properties may help accelerate the healing of infections.

5) Because of its many attributes, Brilacidin could be used for other infectious or inflammatory conditions.  The combination of antibacterial, anti-inflammatory, and anti-biofilm properties is unlike any other antibiotic, and we believe it can be used to treat biofilm-related infections of artificial joints, which is a growing problem in our aging population.  In this space, we are currently conducting a Phase 2 trial assessing the effect of Brilacidin on oral mucositis, an inflammatory condition in cancer patients undergoing chemoradiation therapy.”