Cellceutix Corp (OTCMKTS:CTIX) is making a spectacular move up after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Cellceutix is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
CTIX is one of those legendary stories that we love to report on; from pennies a share back in 2011 to recent highs near $5 CTIX has transformed itself as the top most traded stock on the entire bb’s.
It all comes back to Cellceutix chief scientific officer, Dr. Krishna Menon; the man is a real whiz; he played key roles in developing two blockbuster cancer drugs; Gemzar and Alimta for Eli Lilly & Co.(NYSE:LLY) back in the late 90’s.
For CTIX he developed Kevetrin which is currently in Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute. Kevetrin is successful in regulating the p53 pathway that has long been the holy grail of cancer research and big pharma. Industry leaders spent hundreds of millions of dollars trying to achieve what Dr. Krishna Menon has achieved with Kevetrin.
Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company located in Beverly, Massachusetts developing innovative therapies in oncology, dermatology and antimicrobial applications.
CTIX flagship is Brilacidin, a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the “front line” of defense in the human immune system and mange suggest Brilacidin could rival Cubist’s (NASDAQ:CBST) Daptomycin as the antibiotic of primary choice.
CTIX announced today that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ahead of its meeting this month with Cellceutix regarding Cellceutix’s planned Phase 3 trial of Brilacidin for ABSSSI. Brilacidin, the Company’s lead drug in a new class of antibiotics called defensin-mimetics, completed a Phase 2b trial in September showing, amongst other things, a single dose of Brilacidin to be as effective in treatment of ABSSSI as a FDA-approved seven-day dosing regimen of daptomycin.
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The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.
Among the benefits of QIDP is Fast Track and Priority Review status and a five-period of market exclusivity if approved. Cellceutix acquired Brilacidin last year when they purchased the assets of PolyMedix.
Currently CTIX has over $7 million in the treasury and is fully funded going forward. The stock is just now coming into the price range where they will be noticed by the primary players of biotechnology who could be all over this one. As I have been saying CTIX already looks and feels like a big board stock and is fast outgrowing the bb’s.
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Shareholders have to consider themselves lucky to have Mr. Ehrlich and Dr. Menon running the show. With a Brilacidin phase III trial in 2015 and a truly magnificent drug pipeline opening up the significant short position currently in CTIX has to be seriously concerned, especially after today.
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Disclosure: we hold no position in CTIX either long or short and we have not been compensated for this article.