Cellceutix Submits Special Protocol Assessment Request to FDA for Phase 3 Clinical Trial of Brilacidin for ABSSSI
Study titled: “A Phase 3, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Brilacidin versus IV Vancomycin Followed by Optional PO Linezolid for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)”
BEVERLY, MA–(Marketwired - February 26, 2016) - Cellceutix Corporation (CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that it has submitted a Special Protocol Assessment (SPA) request, along with a final protocol to FDA, for a phase 3 clinical trial of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). A SPA is a written agreement between the U.S. Food and Drug Administration (FDA) and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market. The SPA submission is the next step in beginning a phase 3 program in ABSSSI after a successful End-of-Phase 2 Meeting with FDA last July (2015). The title of the protocol submitted with the SPA request is: “A Phase 3, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Brilacidin versus IV Vancomycin Followed by Optional PO Linezolid for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)”.
Brilacidin is the lead compound in a new class of antibiotics, the HDP mimics. It is the first completely novel antibiotic to enter a Phase 3 trial in ABSSSI in more than two decades and is uniquely qualified to treat Gram-positive pathogens, particularly MRSA, without adding to the burden of antimicrobial resistance. Brilacidin offers several key advantages over recently approved ABSSSI antibiotics, which are newer members of existing antibiotic classes and, as such, are more prone to the development of cross-resistance among bacteria. Like other single-dose ABSSSI regimens, Brilacidin maximizes adherence to the full treatment course, and therefore removes non-compliance as a driver of resistance. However, Brilacidin has the advantage of an intermediate half-life, while other single-dose ABSSSI regimens have very long half-lives, which means these drugs can remain in the body for weeks at low levels, which could further promote the development of resistance. Moreover, Brilacidin has activity against stationary phase bacteria, which play a role in persistent infections and biofilm formation. Finally, Brilacidin has anti-inflammatory properties that may accelerate and promote clinical healing. FDA designated Brilacidin as a Qualified Infectious Disease Product (QIDP) under the GAIN Act in November, 2014.
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Cellceutix clinical trials on Clinicaltrials.gov:
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 multiple diseases. 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 concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. 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.
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