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arGentis Files Patent on Nucleic Acid Sequences and Polymorphisms Predictive of Patient Responses to ARG201 an Immunotherapy for Late Phase Systemic Sclerosis

Tuesday, July 01, 2008

Memphis, TN -- arGentis Pharmaceuticals, LLC announced today that it has filed a patent application for Nucleic Acid Sequences highly associated with the inability of oral immune tolerance to be induced in some systemic sclerosis (SSc) patients. As explained in the patent application, the identified sequences predict which patients can respond to ARG201, an immunotherapy that induces oral immune tolerance in patients with Late Phase diffuse cutaneous systemic sclerosis.

Results from patient DNA samples from a 168-patient, double-blind Phase II trial indicate that 30% of systemic sclerosis patients have a specific nucleotide polymorphism (SNP). This same group of patients did not appear to respond to oral collagen therapy. Approximately 70% of patients did respond to ARG201 therapy. That group did not appear to carry the SNP. The results also demonstrate that there is a statistically significant difference in the changes in cytokine production by T lymphocytes necessary to induce immune tolerance between patients with and without the SNP.

Recently published Phase II results of ARG201 have demonstrated statistically and clinically significant reductions in modified-Rodnan Skin Scores (MRSS) in Late Phase SSc patients, a prospectively defined subpopulation in the trial.

"The SNP enables us to clearly define systemic sclerosis patients who can most benefit from the ARG201 therapy," said Tom Davis, CEO of arGentis. "Screening of Late Phase SSc patients for the SNP prior to Phase III clinical trial enrollment also greatly increases the likelihood of success of those trials." arGentis anticipates beginning Phase III trials in the first half of 2009.

Application of the SNP to identify patients susceptible to successful oral immune therapy in other autoimmune diseases is also being verified in a test group of rheumatoid arthritis patients. Preliminary results are very positive. arGentis researchers believe that the SNP maker may be applicable to achieving oral immune tolerance in many, if not all, autoimmune diseases, providing a platform for developing oral tolerance therapeutics for large subpopulations of those diseases.

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 suffer increasing difficulties with digestion, breathing, joint pain and often develop pulmonary hypertension. Due to differences in immunologic function of the patient groups, SSc can be categorized as Early Phase, patients diagnosed for less than three years, and Late Phase, those diagnosed for more than three years. Median survival from diagnosis is eleven years (Mayes, 2004). There are approximately 80,000 SSc patients in the U.S. with similar numbers in the European Union. No therapies are presently available to treat the underlying cause of the disease.

About ARG201

ARG201 is an immunotherapy designed to induce low-dose oral tolerance in Late Phase systemic sclerosis patients. A multicenter, 168-patient double-blind, placebo-controlled Phase II clinical trial has been completed. ARG201 has been granted orphan status by the U.S. Food and Drug Administration. Phase III trials are expected to begin in the first half of 2009.

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 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, will enter Phase III trials in 2009. The ophthalmology pipeline includes three therapies for dry eye syndrome which are uniquely applied to the outer upper and lower eyelids for transdermal delivery to the affected glands.

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