Company Releases Pictures of Mice Studies Showing Dramatic Response to Drug
BEVERLY, MA–(Marketwire – Sep 26, 2011) – Cellceutix Corporation (OTCQB: CTIX) (PINKSHEETS: CTIX) (the “Company”), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, today released pictures of its mice study with KM-133, the Company’s small molecule acting on the principles of immune stimulation and PRINS reduction as a new treatment for psoriasis. The pictures show a dramatic response to treatment with KM-133. In the studies 100% of the mice responded to the treatment.
The Company also reported that it has engaged its FDA consultant for the purpose of preparing a regulatory pathway with the U.S. Food and Drug Administration (“FDA”) pursuant to Section 505(b)(2) for KM-133, as a new treatment for psoriasis.
Given the fact that the active moiety of KM-133 is an already FDA-approved product, Cellceutix believes that it will be eligible for a 505(b)(2) regulatory pathway, which permits compounds in development to be taken into advanced stages of clinical trials based upon bioequivalence from previously reported filings; saving time and money in the development process.
Research of a human xenograft animal model of psoriasis conducted by Cellceutix on KM-133 measuring it against methotrexate, a commonly used drug today in the treatment of psoriasis, showed a faster reduction of lesion appearance (84% versus 63%), a greater reduction in serum PRINS (96 versus 48%) and a significant reduction in serum IL-20 (87% versus 46%) in models treated with KM-133 as compared to methotrexate. More importantly, psoriasis lesions showed no reoccurrence in models treated with KM-133 throughout the 180-day study whereas psoriasis lesions reappeared in those treated with methotrexate in 61 days.
“Now that we have Kevetrin™ firmly on course for human trials, we can dedicate resources towards other drugs in our pipeline,” commented Cellceutix CEO Leo Ehrlich. “The psoriasis market is a multi-billion dollar opportunity in which we feel we have a competitive edge based upon our pre-clinical data of KM-133 outperforming today’s standards of treatment. The results on the mice were beyond our most optimistic expectations. Most importantly the study used a ‘human xenograft” animal model of psoriasis. We have signed confidential agreements with some large pharmas who have already shown interest in KM-133. Our belief is that based on the chemistry of KM-133, it meets the eligibility for 505(b)(2) clearance which means that we could have two extremely promising drugs in clinical trials in 2012, with KM-133 potentially being in Phase II/III trials. I am excited about all of the developments happening at Cellceutix and look forward to providing shareholders with frequent updates over the coming weeks.”