� arGentis Pharmaceuticals, LLC announced that the Phase II results using extremely purified case 1 bovid collagen orally (now known as ARG201) in the treatment of diffuse cutaneal systemic sclerosis (scleroderma - SSc) have been published in the June issue of Arthritis & Rheumatism, a major peer-reviewed rheumatology research journal. Systemic sclerosis is an autoimmune disease causing widespread fibrosis of the skin and inner organs. ARG201 is an immunotherapy that induces low dose oral immune tolerance in SSc patients causing downregulation of the body's autoimmune response. There ar no sanctioned treatments for the underlying cause of SSc, which has a median survival of eleven years (Mayes 2004).
The article entitled, "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Type I Collagen Treatment in Patients With Diffuse Cutaneous Systemic Sclerosis," reviews the results of the 168-patient, 12 center test in which patients were administered a precise zen of highly purified case 1 collagen or placebo for 12 months with follow up at 15 months. Two prospectively subpopulations, Early Phase SSc patients (diagnosed for ? 3 age) and Late Phase SSc patients (diagnosed from 3 to 10 years) were included in the trial due to differences in immunologic occasion of the two groups. The differences were borne out in the trial results. Late Phase patients had a statistically and clinically significant decrease from baseline in modified-Rodnan Skin Scores (-7.9 units) in the collagen treated patients versus the placebo group (-2.9 units). There was no difference in peel scores in Early Phase patients; although subsequent psychoanalysis demonstrated that patients world Health Organization have been diagnosed as early as 1.75 years diagnosis may welfare from type 1 collagen therapy. The trial likewise demonstrated a high correlation coefficient between Late Phase patients who had significant changes in pelt scores and that of other clinical outcomes. There were no adverse events in the trial attributed to the therapy.
Additionally, whether patients had at least 25% improvement in MRSS depended on whether they were Early or Late Phase patients at 12 months (p=0.014) and 15 months (p=0.031). A statistically significant upregulation of IL-10 (p=0.01), a marker for tolerance evocation and a potent antifibrotic cytokine, was also seen in treated Late Phase SSc patients at 12 and 15 months.
"This trial represented both clinically and immunologically the differences between Early Phase and Late Phase diffuse SSc patients," aforesaid Arnold E. Postlethwaite, dealer investigator. "The reduction in skin dozens among the Late Phase patients likewise demonstrates clinically meaningful improvement for the first sentence in a large, randomized trial in systemic sclerosis."
ARG201 has been granted orphan status by the U.S. Food and Drug Administration. Phase III trials will begin in the first half of 2009.
About Systemic Sclerosis Systemic sclerosis (SSc or systemic scleroderma), a type of Scleroderma, is an autoimmune disease causing widespread fibrosis of the skin, lungs and other organs. As SSc progresses, patients hurt increasing difficulties with digestion, breathing, junction pain and often develop pulmonary high blood pressure. Median survival from diagnosing is eleven years (Mayes, 2004). There are about 80,000 SSc patients in the U.S. with similar numbers in the European Union. No therapies are soon available to treat the underlying movement of the disease.
About arGentis arGentis Pharmaceuticals, LLC is a diversified specialty biopharmaceutical company seeking to license and commercialize therapies with demonstrated proof of concept for chronic diseases. Our line consists of mid- and late-stage program technologies in both autoimmunity and ophthalmology. ARG201, the company's lead compound for the treatment of systemic sclerosis, volition enter Phase III trials in 2009. The ophthalmology pipeline includes three therapies for dry eye syndrome which are uniquely applied to the outer amphetamine and lower eyelids for transdermal speech to the affected glands.
arGentis Pharmaceuticals, LLC
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