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arGentis Expands Scientific Advisory Board Up one folder

Maureen D. Mayes, MD, Daniel E. Furst, MD, Virginia D. Steen, MD and Weng Kee Wong, PhD have joined arGentis' Scientific Advisory Board and will lend their expertise to the company in the clinical development of ARG201 for Systemic Sclerosis.


FOR RELEASE Friday, October 16, 2009

Memphis, TN -- arGentis Pharmaceuticals, LLC announced today that the company has added new members to its Scientific Advisory Board overseeing development of autoimmune related therapies. Dr. Arnold Postlethwaite, Chief Medical Officer and Chairman of arGentis Pharmaceutical's Scientific Advisory Board stated "Our post Phase II data analysis, along with the discovery of a genetic marker highly associated with the induction of oral immune tolerance in systemic sclerosis patients, have opened the door for additional study and development of ARG201 as an effective immunoregulatory therapy. I am extremely pleased that my colleagues, Drs. Mayes, Furst, Steen and Wong will be joining me in advising arGentis Pharmaceuticals on these exciting developments and their paths to commercialization."

Dr. Maureen D. Mayes graduated from Eastern Virginia Medical School and was trained in Internal Medicine and Rheumatology at the Cleveland Clinic. She received a Master's in Public Health (MPH) in Epidemiology from the University Of Michigan School Of Public Health. She came from Wayne State University in Detroit where she was Professor of Medicine to join the University of Texas - Houston Medical School faculty in 2002 and subsequently established the Scleroderma Clinic. Dr. Mayes is the recipient of many distinctions, awards and grants for the study and treatment of scleroderma. She is the author of over 100 published manuscripts, 19 reviews, 5 book chapters and 1 full length book. Her clinical focus includes the treatment of scleroderma and its multiple complications and Dr. Mayes continues to participate in several multi-center, national trials of new agents for this disease. Her research interests include the identification of susceptibility genes and disease activity genes in scleroderma and related autoimmune diseases. She is currently the Principal Investigator of the NIH/NIAMS funded 'Two-Stage Genome-Wide Association Study in Scleroderma' that has the dual objectives of identifying genes that influence disease susceptibility and severity, as well as to serve as a national resource to supply genetic material to other investigators to study this disease.

Dr. Daniel E. Furst is the first Carl M. Pearson Professor of Medicine at the University of California, Los Angeles (UCLA), Medical Center. Dr. Furst received his MD from Johns Hopkins University and two fellowships (Rheumatology in clinical pharmacology). Dr. Furst has been on a number of national committees concerned with rheumatic therapeutics. He recently was co-leader of the ACR recommendations for the use of non-biologic and biologic therapies in rheumatoid arthritis (RA) and is a Master of the ACR. Dr. Furst has published more than 450 articles and 14 books, including more than 220 research articles. Dr. Furst’s areas of research interest include the clinical pharmacology of anti-rheumatic drugs and biologics, and the pathophysiology and treatment of systemic sclerosis.

Dr. Virginia D. Steen is a Professor of Medicine and Chief of Rheumatology at Georgetown University School of Medicine. Dr. Steen received her MD from the University of Pittsburgh with residency at the University of Pennsylvania and fellowship at the University of Pittsburgh. Her research interests are focused on the epidemiology, natural history risk factors and clinical trials in scleroderma. She has additional clinical interests in all the connective tissue diseases, including lupus, myositis rheumatoid arthritis.. She has served as Principal Investigator, Co-Principal Investigator, and Mentor on numerous research projects and clinical trials and is an internationally recognized expert in scleroderma. Dr. Steen has been very active in organizations addressing rheumatic diseases. She consults with the Arthritis Center of the National Institutes of Health (NIH) and is on the medical board for the Scleroderma Foundation. She reviews grants and manuscripts for many organizations including the NIH and the American College of Rheumatology and most of the rheumatology journals. She has served on many committees for the ACR. Her most recent interest is in the area of pulmonary disease in scleroderma and is the coordinating investigator for a 20-site scleroderma pulmonary hypertension registry.

Dr. Weng Kee Wong is a Professor of Biostatistics at the UCLA School of Public Health. Dr. Wong received his Masters and PhD in Statistics from the University of Minnesota, Minneapolis-St. Paul. Dr. Wong received a Masters in Mathematics at the University of Wisconsin-Milwaukee and his Bachelors in Mathematics at the National University of Singapore. Dr. Wong’s general area of research is in optimal design of experiments with applications to clinical trials and non-linear models with particular interest in the construction of multiple-objective designs. Dr. Wong’s work is published in both theoretical and applied journals in statistics, including pharmaceutical sciences and theoretical biology. In 1997, Dr. Wong was awarded the First Independent Research Support and Transition Award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

ARG201, pioneered by Arnold Postlethwaite, M.D., Chief of Rheumatology at The University of Tennessee Health Science Center and Andrew Kang, M.D., Professor of Medicine in Rheumatology at The University of Tennessee Health Science Center, is an immunotherapy that induces low dose oral immune tolerance in SSc patients causing downregulation of the body's autoimmune response. It has completed a Phase II clinical trial. Data from the trial demonstrated a statistically and clinically significant improvement in Modified Rodnan Skin Scores (MRSS), a measure of the change in skin thickening and an FDA-mandated endpoint, at 15 months in late phase patients receiving the treatment versus the placebo group (p=0.006). ARG201 was also granted Orphan Drug Designation in both the U.S. and the EU. arGentis is now developing the next phase clinical and regulatory protocols and will commence its additional systemic sclerosis clinical trials following the conclusion of its current capital funding program.

Tom I. Davis II, arGentis Pharmaceuticals CEO, stated "The willingness, of these well-known researchers in the field of scleroderma, to advise arGentis validates the credibility of the research performed by Drs. Postlethwaite and Kang. arGentis is fortunate to have the support of such highly respected experts and their invaluable guidance will assist us during our continuance of clinical testing our therapy for this dire unmet medical need."

About Systemic Scleroderma and Systemic Sclerosis

Scleroderma is a disease that causes thickened skin and varying degrees of organ dysfunction resulting from small-vessel vasculopathy and immune-mediated fibrosis. The clinical manifestations of this disease are extremely heterogeneous and depend on the presence and degree of internal organ involvement. Patients may present with a spectrum of illness ranging from localized skin fibrosis only (localized scleroderma) to a systemic disorder (systemic scleroderma or systemic sclerosis) with both cutaneous and internal organ involvement. The latter is the most severe with a median patient survival of 11 years (Mayes 2004) from diagnosis. Studies reflect there are approximately 100,000 systemic sclerosis patients in the U.S. with similar numbers in the EU.

About arGentis

arGentis Pharmaceuticals, LLC is a diversified biopharmaceutical development company located in Memphis, TN. The company seeks to in-license therapies for chronic diseases with demonstrated proof of concept for further development and commercialization. The company's pipeline consists of mid- and late-stage platform technologies in both autoimmunity and ophthalmology. ARG201, the company’s lead compound for the treatment of systemic sclerosis, along with the ROT1 genetic biomarker highly associated with identifying patient responders to ARG201 therapy are being positioned for late phase clinical development. arGentis' ophthalmology pipeline includes three therapies for dry eye syndrome which are uniquely applied to the outer upper and lower eyelids for transdermal delivery to affected glands.

Contact

Ted Townsend, Vice President and CAO, arGentis Pharmaceuticals, LLC, 901-448-2024

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