SOURCE: Cellceutix

Cellceutix

October 30, 2015 07:30 ET

Cellceutix Provides Brilacidin Update; New Class of Antibiotics to Enter Phase 3

BEVERLY, MA--(Marketwired - October 30, 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 provide an update on brilacidin, a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics or defensin-mimetics. Last year, the Company successfully completed a phase 2b study in patients with Acute Bacterial Skin and Skin Structure Infections (ABBBSI). There were there were no serious adverse events (SAEs) that were deemed by the principal investigator (PI) as related to study drug. Efficacy was high across all brilacidin treatment groups, including the two single-dose groups, and similar to daptomycin, the active comparator. "To show similarity to a gold standard such as daptomycin is impressive -- especially when our drug is given one time, while daptomycin is given every day for seven days," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "I am very happy that we acquired brilacidin and the other HDP mimics. We acquired the HDP mimics for a song, a move that, considering all that we've already accomplished, I anticipate to turn out as a phenomenal business decision for Cellceutix shareholders."

Brilacidin received Qualified Infectious Disease Product (QIDP) designation under the GAIN Act in November 2014, and the Company had a positive End-of-Phase 2 Meeting with FDA in July 2015.

Although phase 3 start up activities may take a little longer than usual for a new class of compounds, the Company remains on track in its preparations.

"We are producing large quantities of brilacidin that can be used in the phase 3 program, and in the coming weeks, we will be completing our laboratory testing on the newly manufactured compound," said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Our goal is to maximize the purity of the compound for phase 3 studies. We have accomplished this in making the active pharmaceutical ingredient (API) so that the final product is greater than 99% pure, with a very high yield. In lab tests so far, the new compound has passed all our rigorous quality control tests and we are very pleased with what we see."

In addition, the Company has completed its interviews of Contract Research Organizations (CROs) that have experience conducting global phase 3 ABSSSI studies.

"It has been decades since a new class of antibiotics has made it to phase 3," said Dr. Daniel Jorgensen, Cellceutix's Chief Medical Officer. "Brilacidin is unique in its structure and function. As an antibiotic, it is can kill bacteria that are resistant to other antibiotics, such as methicillin-resistant Staphylococcus aureus (MRSA), a major cause of ABSSSI. And we believe that resistance to brilacidin is unlikely to occur. As for brilacidin's immunomodulatory activity, we are just scratching the surface."

Although ABSSI may appear to be a crowded space, the Company believes that brilacidin has several advantages over existing ABSSSI therapies. These include:

  1. It 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. As the first in a new class of antibiotics known as Host Defense Protein (HDP) mimics, 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 also 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. This means that brilacidin, unlike other ABSSI drugs, has the potential to be used for biofilm-related infections caused by Staph aureus. In addition, by killing bacteria in both phases (rapid growth and stationary), 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 the molecules (HDPs) that comprise 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. In addition, these properties allow us to use brilacidin for inflammatory conditions. For example, brilacidin is in a phase 2 study as an oral rinse for the prevention of oral mucositis in patients undergoing chemoradiation for head and neck cancer.

"We are all excited by the possibilities for treating infections and inflammatory conditions," concluded Mr. Ehrlich. "Brilacidin could truly be a game changer."

Elsewhere in the Cellceutix pipeline, the Company wishes to inform shareholders that the documentation has been submitted to the U.S. Food and Drug Administration (FDA) requesting a meeting for Cellceutix's planned phase 2 trial of Kevetrin for ovarian cancer.

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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 is in 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 is in 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.

Forward-Looking Statements

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    Cellceutix Corporation
    Leo Ehrlich
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