SOURCE: Cellceutix

Cellceutix

October 13, 2015 07:30 ET

Cellceutix Provides Update on Its Phase 3 Preparations for ABSSSI

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 against Staphylococcus 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.

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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
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

Contact Information

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