SOURCE: Cellceutix

Cellceutix

November 25, 2015 08:00 ET

FDA Grants Fast Track Designation to Cellceutix's Brilacidin-OM for Oral Mucositis

BEVERLY, MA--(Marketwired - November 25, 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 announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company's novel defensin-mimetic Brilacidin, for the prevention of oral mucositis. Oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side-effect of certain cancer treatments, afflicts approximately 450,000 patients each year in the United States and can affect the course and outcome of cancer therapy. There are no FDA approved drugs for the prevention of oral mucositis.

In an ongoing Phase 2 trial, Brilacidin-OM is being evaluated for its safety and efficacy in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer. Seven clinical sites and two satellite sites are currently enrolling patients in the trial, with additional sites expected to open enrollment in the coming weeks.

The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval.

"Hundreds of thousands of patients suffer from oral mucositis each year, including many of the approximately 60,000 patients diagnosed with head and neck cancer, with no drug available to help prevent it," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We are very optimistic about our defensin-mimetic franchise given the strong antibacterial properties of Brilacidin-IV shown in clinical trials for ABSSSI and lab studies demonstrating the anti-inflammatory and anti-biofilm properties of Brilacidin-OM, which we hope to validate in the Phase 2 trial in oral mucositis patients. The Fast Track Designation provides us a greater opportunity to interact with the FDA and the possibility of other programs to assist in hastening the development of Brilacidin-OM. With the Orphan Drug Designation for drug Kevetrin to treat retinoblastoma, an FDA meeting being scheduled at the beginning of 2016 for our planned Phase 2 trial of Kevetrin for ovarian cancer, which is also being developed under an Orphan Drug Designation, and now this Fast Track Designation for Brilacidin-OM, it's been a solid month of developments with the FDA for our oncology pipeline."

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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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Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email contact