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.