Cellceutix To Expand Its Skin Product Pipeline

BEVERLY, MA--(Marketwired - March 02, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that it is expanding its dermatology pipeline to include novel Human Defense Protein (HDP) mimetics for the treatment of chronic skin conditions, such as acne vulgaris, rosacea, and hidradenitis suppurativa (HS). Recently conducted pre-clinical research supports these conditions as targets due to the robust antimicrobial and anti-inflammatory properties of Cellceutix’s HDP mimetics. These are conditions for which there is no consistently effective treatment, as in the case of HS, or there is room to improve upon current therapies, as in acne vulgaris or rosacea. In these conditions, topical antibiotics have been used, with mixed or disappointing results, most likely due to a lack of anti-inflammatory activity in concert with an inability to treat bacteria, such as Propionibacterium acnes, that are growing increasingly resistant to current therapies. The HDP mimetics can overcome both hurdles: they have anti-inflammatory properties and they can kill key bacteria without promoting further resistance. The latter is important, because traditional antibiotics, when chronically used, are likely to promote resistance, whereas HDP mimetics, given their unique structure and mechanism of action, are unlikely to promote resistance.

Building upon completed research for other indications Cellceutix is developing drugs to treat, it has been determined that the most promising application is the treatment of hidradenitis suppurativa (HS), also known as “acne inversus,” a chronic inflammatory condition of the sweat glands, characterized by painful lumps and sores, often discharging pus, and resulting in scarring and tunnels under the skin. There is no known cure, and no consistently effective treatment. Approximately 1% of the population suffers from this condition, representing a large unmet medical need. Conventional antibiotics have been used with minimal success, while increasing the risk of antimicrobial resistance among skin bacteria. Infliximab, a TNF alpha inhibitor, has been used off-label in severe refractory cases with mixed results, though the risk/benefit ratio has not been fully established in this indication. TNF alpha inhibitors and other biologics are powerful drugs given by IV infusion and their long-term safety profiles have not been well established in this condition. Moreover, treatment courses are very expensive.

“These novel HDP mimetics are a great addition to our growing dermatology pipeline, which already includes Prurisol for psoriasis,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “With the HDP mimetics, we can expand into a variety of chronic skin conditions, which require antibiotic compounds with anti-inflammatory properties -- with minimal risk of resistance. This is truly an area of unmet medical need and a fantastic complement to our HDP mimetic franchise. We see a very clear regulatory pathway for hidradenitis suppurativa and will file an IND with the FDA once the formulation is completed.”

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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 will soon begin 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 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 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.

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