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QUATRX ANNOUNCES RESULTS FROM PHASE 2B CLINICAL STUDY OF BECOCALCIDIOL IN PSORIASISStudy of novel topical vitamin D analogue meets primary endpoints. [Released June 14, 2005] ANN ARBOR, MI—A Phase 2B study of patients treated with becocalcidiol, a topical vitamin D analogue for the treatment of mild to moderate psoriasis, met the primary study endpoints. The study results were announced today by QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company developing new therapies to treat cardiovascular, metabolic and endocrine diseases. The multi-center study, conducted at 12 sites across the U.S., involved 185 patients treated for eight weeks, and included three arms: high dose becocalcidiol, low dose becocalcidiol and vehicle (the equivalent of placebo for topical therapies). Patients at both high and low dose levels of becocalcidiol demonstrated a statistically significant difference from vehicle based on the primary endpoint of the physician's global assessment showing psoriatic lesions clear or almost clear. Greater than five times the number of patients reached this endpoint at the high dose of becocalcidiol compared with vehicle. Patients treated at the high dose level also showed a statistically significant reduction in psoriasis symptom severity and affected body surface area compared to vehicle. Becocalcidiol at both dose levels was well tolerated and adverse events were infrequent. The findings were also consistent with several previous studies indicating that treatment with becocalcidiol did not affect calcium parameters in these patients. "Millions of patients worldwide suffer from psoriasis. We are very encouraged by the positive results of this study. Becocalcidiol shows great promise and, as a result, QuatRx looks forward to the next stage of development for this compound." said Robert L. Zerbe, M.D., president and CEO of QuatRx. QuatRx owns exclusive worldwide marketing and distribution rights for becocalcidiol as a topical treatment for skin disorders. The company is currently entering into discussions with potential corporate partners in preparation for Phase 3 studies and commercialization of becocalcidiol. About Psoriasis Psoriasis is a chronic skin disorder affecting more than 18 million people worldwide and characterized by skin cells that multiply faster than normal. Instead of shedding like normal skin cells, psoriatic skin cells pile up on the skin's surface and form lesions—usually raised, red patches covered with a silvery-white scale. The condition can affect any area of the body but is most commonly found on the scalp, elbows, knees, hands, feet and genitals. Of patients diagnosed with psoriasis, over 80% receive treatment with topical therapy. The global market for topical psoriasis treatments is estimated at about $500 million annually. About QuatRx QuatRx Pharmaceuticals Company, a biopharmaceutical company, focuses on research and development of therapeutic compounds primarily for the treatment of major endocrine, metabolic and cardiovascular diseases, especially dyslipidemia and endocrine diseases of aging. QuatRx has its headquarters in Ann Arbor, Michigan, with a significant presence in Europe through Hormos Medical Corp (a wholly-owned subsidiary of QuatRx Pharmaceuticals Company), located in Turku, Finland. QuatRx's robust pipeline includes four compounds in clinical development. The research activities of the company are based on its expertise in tissue-specific steroid hormone effects at the molecular and cellular level. With significant financial backing from top-tier venture capital firms and strong development capabilities, QuatRx continues to advance and expand its portfolio of development-stage compounds.
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© 2008 QuatRx Pharmaceuticals Company Terms of Use |
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