October 7, 2009 (FinancialWire) — Cellceutix Corp. (OTCBB: CTIX) has successfully completed a study with its proprietary compound, KM-133, in a human xenograft animal model of psoriasis.

The study showed that KM-133 reduced psoriasis more than controls (p<0.01). The higher of two doses of KM-133 reduced psoriasis more than methotrexate (p<0.01). Psoriasis did not recur with KM-133 during the entire course of the experiment, whereas psoriasis reoccurred in the group of animals treated with methotrexate after an average of 61 days. The study also looked at histological indications of psoriasis as well as three bio-markers, PRINS, IL-20 and 12-R lipoxygenase, and found that KM-133 had significant effects on all these parameters. Weight losses for the KM-133 treated animals were within acceptable limits.

“Those suffering from psoriasis clearly know the urgent need for new treatments. In order to increase the predictive ability of the study, we designed an animal model with human psoriatic tissue to simulate psoriasis in humans. These results clearly show that the higher dose of KM-133 had a superior effect in psoriasis when compared to methotrexate, a standard treatment,” said Dr. Krishna Menon, chief scientific officer of Cellceutix.

In this study, four groups of ten mice were treated with a single dose per day of KM-133 (10 mg/kg), 2 doses of KM-133 (10 mg/kg x 2) per day, methotrexate (7.5 mg/kg) or acted as controls. The mice were irradiated and then engrafted with human psoriatic tissue. The animals were dosed orally for 14 consecutive days, then observed for 180 days. Endpoints were skin appearance, histological observation, PRINS, IL-20, CD 4, CD 8 and 12-R lipoxygenase. On these parameters, KM-133 was compared to the control group and to the methotrexate treated group. In addition, CD4 and CD8 were measured and compared with efalizumab. These comparisons showed that KM-133 produced less severe immunosuppression than efalizumab.

According to the National Institutes of Health, as many as 7.5 million Americans (125 million worldwide) have psoriasis, making this one of the most prevalent autoimmune diseases in the U.S affecting all ages of both sexes. Additionally, studies show that between 10 and 30 percent of people with psoriasis also develop psoriatic arthritis.

Psoriasis greatly affects the quality of life of those with the disease; especially those with moderate to severe psoriasis. Nearly 60 percent of people with psoriasis reported their disease to be a large problem in their everyday life, making psoriasis much more than a “cosmetic problem.” It is estimated that the total direct and indirect health care costs of psoriasis for patients are calculated at $11.25 billion annually, with work loss accounting for 40 percent of the cost burden.

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