Cellceutix Corporation is not a company standing still. The emerging biotech has 8 compounds in their portfolio, with two of them being actively developed by the Company. Kevetrin, Cellceutix’s lead compound is in development for the treatment of multi-drug resistant cancers and is rapidly approaching human trials as the IND filing with the FDA is being prepared. KM-391 has already garnered industry attention as it is being developed to address the core issues of autism.
Constantly moving forward, Cellceutix announced in late July that they have retained Destum Partners to identify and secure a developmental partner for another very promising compound in their portfolio. KM-133 has already undergone some preclinical testing as a new treatment for psoriasis. Cellceutix believes that KM-133 will have industry appeal in targeting a partner due to preclinical results, industry growth and the fact that KM-133 may qualify for an exemption that allows it to forgo more Phase I trials and move directly into Phase II human trials.
One particular test compared KM-133 to methotrexate, which is commonly used today to treat severe psoriasis. The testing was done through human xenografts, which are the grafting of human skin affected by psoriasis onto an animal, in this case, mice. Throughout the course of the entire 6 months of the experiment, the animals treated with KM-133 demonstrated no recurrence of psoriasis lesions, while the animals treated with methotrexate had lesions reappear in 61 days.
In 2010 an estimated 18 million people in the 7 major markets suffered from Psoriasis. Estimates worldwide put the number as high as 125 million people being affected. The revenues generated from the treatment of the disease were approaching in $3 billion in 2008 alone. . While estimates vary, according to a report from Global Industry Analysts, Inc., the global psoriasis drugs market is estimated to exceed $7.3 billion by 2015. There are very few drugs on the market today that treat psoriasis exclusively. Enbrel, for example, treats both psoriasis and rheumatoid arthritis and is marketed by Pfizer (NYSE: PFE) and Amgen (NASDAQ: AMGN). A drug uniquely for psoriasis opens up lucrative market potential with the successful development of KM-133.
There is a FDA rule, termed “Rule 505(b) (2)”, that permits the bypassing pre-clinical testing if the active ingredient in a compound has previously been approved by the FDA. Due to the chemical base of KM-133, it has the potential of this rule being applicable, thus saving a great deal of time and money by moving directly into human trials.
The website for the National Psoriasis Foundation has 11 oral drugs in development presently. If KM-133 is approved for the 505 exemption, it will be right in the mix as 10 of the 11 drugs are presently in Phase II clinical trials. With these facts in mind, it is understandable why Cellceutix has taken the progressive approach with contracting Destum to bring further development of KM-133 to fruition.
CTIX is still a “sleeper” in the stock market world, but certainly portrays many of the qualities of a biotech that could explode upon news. Led by CEO George Evans and his more than 25 years as an executive for pharma giant Pfizer, including ending his career as General Counsel for the worldwide prescription drug unit, Cellceutix may soon be appearing on more biotech investor’s radar as they continue to push forward with development of their compounds.
More information on Cellceutix, their compounds and the investment opportunity they present can be found on the CTIX website at www.cellceutix.com.
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