BEVERLY, Mass., Oct. 5, 2009 (GLOBE NEWSWIRE) -- Cellceutix Corporation (OTCBB:CTIX) today announced that it 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.
About Psoriasis:
According to the National Institutes of Health (NIH), 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.
For a more complete description of this study please visit our Company's website at at www.cellceutix.com.
About Cellceutix
Cellceutix Corporation is a preclinical cancer and anti-inflammatory drug developer. Cellceutix owns the rights to seven drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-133, which it is developing for the treatment of psoriasis. More information is available on the Cellceutix web site at www.cellceutix.com.
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This Press Release contains forward-looking statements that are based on our current expectations, beliefs and assumptions about the industry and markets in which Cellceutix Corporation operates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Cellceutix's actual results to be materially different from any future results expressed or implied by these statements. Actual results may differ materially from what is expressed in these statements, and no assurance can be given that Cellceutix can successfully implement its core business strategy and improve future earnings.
The factors that may cause Cellceutix's actual results to differ from its forward-looking statements include: Cellceutix's current critical need for additional cash to sustain existing operations and meet ongoing existing obligations and capital requirements; Cellceutix's ability to implement its new product development and commercialization, enter into clinical trials, expand the intellectual property portfolio, and receive regulatory approvals in a timely and cost-effective manner. All forward-looking statements are also expressly qualified in their entirety by the cautionary statements included in Cellceutix's SEC filings, including its quarterly reports on Form 10-Q and its annual report on Form 10-K.
The results of these studies have not been reviewed by people outside Cellceutix. KM-133 has not been studied in humans at this time. The Company's positive results in animal studies do not necessarily guarantee success in humans, though they may form the basis for beginning Phase 1 trials.