arGentis Signs Agreement with LifeCyte to Develop cGMP Facility

MEMPHIS, Tenn.--(BUSINESS WIRE)--arGentis™ Pharmaceuticals, LLC announced today that it had signed an agreement with LifeCyte Inc., a Memphis-based biopharmaceutical services company, to assist in the design and development of a dedicated current Good Manufacturing Practices (cGMP) facility that will purify arGentis’ collagen products portfolio.

“Our experience in delivering effective process development and cGMP production solutions will facilitate completion of their advanced clinical trials and the forthcoming market launch of collagen therapies.”

Initially bovine native type 1 collagen (CI) will be purified for use in ARG201, arGentis’ treatment for systemic sclerosis (SSc). Pending discussions with the FDA, ARG201 is expected to enter a Phase III clinical trial in 2008.

arGentis will also produce various types of highly purified (>98%) collagen used for the research and the medical device industries. The proprietary process, pioneered by Dr. Andrew Kang during his 35 years of collagen research, will enable arGentis to produce collagen that is among the purest in the world. LifeCyte is working with arGentis on process development, facility design, quality assurance and control, and implementing standard operating procedures to meet regulatory guidelines. arGentis has commenced their site selection process for the new cGMP facility and will finalize the location over the next several months.

“arGentis’ plan is to move the collagen production process from the laboratory into a facility that can purify commercial quantities. This will enable us to use virtually the same purification process under GMP guidelines and ensures that the collagen produced for the ARG201 clinical trial maintains the same immunologic activity and consistency of results as the earlier trials. In addition, the purity and variety of collagens that will be produced at the cGMP facility also affords us a revenue opportunity by providing highly purified collagen to the research and medical device markets,” said Tom Davis, CEO of arGentis.

In addition to type 1 collagen that will be used in the upcoming late-stage trial for SSc, arGentis Collagen Labs will produce multiple types of collagen with broad ranging deliverables. The end result of the highly specialized process is a premium grade collagen that has low cross-link properties ensuring a more homogenous product that can be used to produce mixtures for Extra Cellular Matrix-like growth vehicles, dermal implants, hemostat agents, wound and burn dressings, periodontal membranes, sutures and corneal shields.

“We are very pleased to have the opportunity to work with the dynamic arGentis team of collagen experts who are dedicated to advancing treatment options for sufferers of Systemic Sclerosis,” commented Natika Calhoun, LifeCyte CEO. “Our experience in delivering effective process development and cGMP production solutions will facilitate completion of their advanced clinical trials and the forthcoming market launch of collagen therapies."

About LifeCyte

LifeCyte, Inc. is a contract biopharmaceutical services company providing laboratory, analytical, and cellular therapy development services. Their expert team provides custom-tailored solutions which accelerate time to commercialization and decrease production costs. LifeCyte operates under GLP, GTP and GMP standards and provides quality systems and advanced translational development services for cell-based and regenerative medicine products, as well as cGMP manufacturing for medical device products. The company maintains corporate headquarters in Memphis, Tennessee. For more information, visit www.lifecyte.com.

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, ARG201 which has successfully completed a Phase II clinical trial. http://www.argentisrx.com

About Systemic Scleroderma ARG201

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. There are no therapies presently available to treat the underlying cause of the disease.

ARG201 has completed a NIH-funded, 168-patient, double-blind, placebo-controlled Phase II clinical trial. 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 late phase patients receiving CI versus the placebo group (p=0.006). CI was also shown to be safe and well-tolerated.