SOURCE: Cellceutix

April 01, 2014 08:00 ET

Cellceutix Comments on Positive FDA Advisory Vote for Dalbavancin and Tedizolid

BEVERLY, MA--(Marketwired - Apr 1, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company") is pleased to comment to its shareholders on yesterday's exciting regulatory developments and how it impacts Cellceutix's drug, Brilacidin.

We are pleased to see yesterday's positive FDA Advisory Committee vote for two antibiotics, dalbavancin and tedizolid, which treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Gram-positive organisms, such as Staph aureus. Although the U.S. Food and Drug Administration (FDA) is not bound to the recommendation of the advisory panel, if the drugs garner FDA marketing approval, the tedizolid regimen would be once a day for 6 days and the dalbavancin regimen would be one treatment during the first week with a second dose required the following week. This positive vote confirms the medical need for new drugs to treat serious skin infections, which are often caused by methicillin-resistant Staph aureus (MRSA), and most important for Cellceutix, further indicates a clearly defined regulatory pathway for antibiotic approvals. 

These two drugs are actually new versions of already existing drugs, and therefore, bacteria may develop cross-resistance. That is, resistance already exists against similar compounds from the same chemical family, and therefore could potentially develop against the new compounds. We feel confident that the medical community, as well as the FDA, will fully embrace a new and innovative class of antibiotics, the defensin-mimetics, of which Brilacidin is the lead candidate. Because there is nothing else in the community that is similar to Brilacidin, and due to its unique mechanism of action, we feel that resistance is unlikely to develop against Brilacidin. In addition, Brilacidin is currently being studied in a Phase 2b clinical trial as a very short course regimen (1 to 3 days), which provides advantages in terms of patient compliance and decreased days of hospitalization. Currently, the shortest course regimen on the market to treat ABSSSI is given once a day for 7 days. We believe that among comparably priced drugs that are safe and effective, the shortest course regimen will take over the market.

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 antibiotic 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 planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is presently in a bioequivalence crossover clinical trial in Miami, FL. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for 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

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

    Cellceutix Corporation
    Leo Ehrlich
    (978) 236-8717
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