BEVERLY, MA–(Marketwired – October 13, 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 it continues to progress towards starting a phase 3 study for Brilacidin intravenous (IV) in the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). In September, Cellceutix submitted its initial Pediatric Study Plan (PSP) to the Food and Drug Administration (FDA) for the use of Brilacidin IV in the treatment of ABSSSI in children. Cellceutix agreed to submit the PSP during its end-of-phase 2 meeting with FDA in mid-July. The submission of the PSP is the first of many requirements in expanding the use of Brilacidin to children.
Cellceutix is engaged in other phase 3 start-up activities. For example, the Company recently received the Brilacidin active pharmaceutical (API) from its contracted manufacturer. The API which has already passed all quality control tests at the manufacturer is now undergoing additional rigorous laboratory testing by our vendors to make certain it’s up to the standards we require for the drug. We will test it head-to-head with the product used in earlier studies. Thereafter, we will begin the process of preparing the formulation for the phase 3 clinical study by using lyophilization. Lyophilization is a freeze-drying process that makes the drug more stable at room temperature, which has benefits for storage, transportation and administration. In addition, the Company is continuing its interviews of leading sites and Contract Research Organizations (CROs) that have experience conducting global ABSSSI studies.
“As the manufacturing process of Brilacidin for the phase 3 trial is the final product that would be used for commercialization should the trial be successful and all regulatory marketing approvals be obtained in the future, we are conscientious to ensure it is exactly what we want it to be,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We know of companies that failed to be meticulous in this matter heading into a pivotal trial and it has come back on them; that’s a mistake we don’t intend to make.”
Brilacidin, the first in a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics, has potent activity againstStaphylococcus aureus, including methicillin-resistant S. aureus (MRSA). Brilacidin received Qualified Infectious Disease Product (QIDP) designation under the GAIN Act in November 2014.
The goal of phase 3 is to confirm the safety and efficacy of single-dose Brilacidin IV against a commonly used antibiotic in large groups of ABSSSI patients worldwide. Because of its novel structure, unique killing properties, and ability to be given as a single-dose, Cellceutix believes Brilacidin IV presents a significant market opportunity in ABSSSI. Brilacidin has the potential to mimimize the burden of antimicrobial resistance, relative to approved ABSSSI compounds, and its anti-inflammatory activity may promote the clinical resolution or healing of skin lesions. Cellceutix plans to use ABSSSI as a gateway to other indications in areas of unmet medical need. This includes, but is not limited to, biofilm-related infections caused by MRSA.
Cellceutix also wishes to announce that next week it will be updating its shareholders about its Proxy as well as the Annual Meeting planned for December 2015.