PRESS RELEASE: arGentis Signs Exclusive License Agreement with UTRF for Scleroderma Treatment

arGentis Signs Exclusive License Agreement with UTRF for Scleroderma Treatment

MEMPHIS, Tenn., Aug. 14 -- arGentis Pharmaceuticals, LLC announced today an agreement with The University of Tennessee Research Foundation to license the intellectual property surrounding the use of solubilized type 1 native bovine collagen (CI) as a treatment for systemic sclerosis (SSc or systemic scleroderma) and other fibrosing diseases. The agreement gives arGentis the rights to the treatment as well as the processes involved in manufacturing the pharmaceutical product.

Systemic sclerosis (SSc or systemic scleroderma), a type of Scleroderma, is an autoimmune disease where the immune system attacks the body's own type 1 collagen causing 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. Median survival from diagnosis is eleven years (Mayes, 2003). There are approximately 100,000 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.

The use of orally administered, highly purified native bovine type 1 collagen (CI) for the treatment of SSc was pioneered by Arnold Postlethwaite, M.D., Director of the Division of Connected Tissue Disease 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. According to Dr. Postlethwaite, "One of the most widely distributed auto-antigens in SSc is type I collagen (CI), the most abundant protein in the body and a component of all tissues, organs and blood vessels involved in the disease processes of SSc. Immune tolerance is induced by orally introducing type 1 collagen, meaning that the body's immune system, over time, ceases to attack its own type 1 collagen."

CI has completed an NIH-funded, 168-patient, double-blind, placebo-controlled Phase II clinical trial with 13 major Rheumatology Centers participating to include Johns Hopkins University, Northwestern University Medical School, UCLA and The University of Tennessee Health Science Center. The trial included patients with the diffuse form of systemic sclerosis. These patients have cutaneous sclerosis over the limbs, trunk, and face with fibrosis of internal organs as well. In addition to the placebo group there were two prospectively defined subgroups in the Phase II trial: patients who had been diagnosed for less than three years (early phase) and those diagnosed from three to ten years (late phase). Patients were treated for 12 months with follow up at 15 months. Data from the trial demonstrated a statistically 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 early phase patients receiving CI versus the placebo group (p=0.006). CI was also shown to be safe and well-tolerated.

"With no therapies to treat the underlying cause of SSc, the prognosis for diagnosed patients is very poor," stated Tom Davis, CEO of arGentis. "Bringing the CI therapy to market will bring hope to tens of thousands of patients with the diffuse form of the disease. We anticipate a post-Phase II meeting with the FDA and EMEA in the next several months. These meetings should give us further clarity of the clinical path necessary for approval. arGentis is pleased to add this therapy to our existing pipeline of products targeting chronic disease states. With CI's successful completion of both a Phase I and Phase II trial, we determined that it met our technology transfer selection criteria."

"UTRF is proud to have arGentis as the exclusive licensee of the Scleroderma treatment technology developed at The University of Tennessee," stated Dr. Fred Tompkins, President of UTRF. "We look forward to working with the strong management team at arGentis as they further develop this technology to meet an important health need. UTHSC researchers Arnold Postlethwaite and Andrew Kang have worked for years to gain an understanding of Scleroderma and to find an effective treatment for this devastating condition. Thus, it was both exciting and gratifying to see that arGentis immediately recognized the potential of their research findings. This is a clear example of how academic researchers and the commercial sector can work together for the benefit of the broader community."

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 from diagnosis.

About arGentis

arGentis Pharmaceuticals, LLC is a specialty pharmaceutical 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 has two pre-clinical drug formulations in development for the treatment of Dry Eye Syndrome. In addition, arGentis has licensed a treatment for Systemic Sclerosis which has successfully completed a Phase II clinical trial.

About UTRF

The University of Tennessee Research Foundation (UTRF) provides research and technology transfer services to The University of Tennessee, including a number of technology management-related services to include identification of promising new inventions, management of intellectual property protection matters, marketing of innovative technologies to the private sector, assisting start-up companies based on intellectual property, licensing of University-developed technologies to promote commercialization, advising, counseling, and assisting in the formation of sponsored research agreements as well as the processing of confidentiality and materials transfer agreements.