Biotechnology Firm ImmuneWorks Begins National Clinical Trial for New Idiopathic Pulmonary Fibrosis (IPF) Investigational Treatments

INDIANAPOLIS (October 19, 2010) – ImmuneWorks, Inc. today announced the initiation of its Phase I clinical trial to evaluate the safety, tolerability, and biologic effects of three doses of IW001 in patients suffering from idiopathic pulmonary fibrosis (IPF), a serious lung disease. The clinical trial will move the biotech company one step closer to commercialization of its lead IPF treatment compound.

“We are pleased to move forward into clinical investigation of IW001 in patients suffering from IPF as we believe that it represents a truly novel approach to therapy in this deadly disease,” said ImmuneWorks Chief Scientific Officer David S. Wilkes, M.D. “This IPF clinical trial is important to study the safety of this naturally derived protein and investigate its ability to influence the ongoing immune response in IPF patients.”

ImmuneWorks’ lead product, IW001, is an oral solution of Type V collagen, which is a naturally occurring protein in the human body. Administration of Type V collagen has been shown in animal models of lung disease to induce immune tolerance and prevent progression of lung fibrosis. IW001 was granted orphan drug status by the U.S. Food and Drug Administration (FDA) in 2009 for IPF.

The ImmuneWorks Phase I clinical trial is expected to enroll approximately 30 patients at eight academic research centers in the United States. Research centers expected to participate in the trial are:

Indiana University, Indianapolis, Ind.
Medical University of South Carolina, Charleston, S.C.
Ohio State University, Columbus, Ohio
University of Alabama-Birmingham, Birmingham, Ala.
University of Chicago, Chicago, Ill.
University of Louisville, Louisville, Ky.
University of Michigan, Ann Arbor, Mich.
University of Vermont, Burlington, Vt.

To promote the clinical trial and recruit participants across the eight cities, ImmuneWorks partnered with Indianapolis-based Synergy Marketing Group to develop a new website and conduct search engine optimization (SEO) to reach IPF patients and their physicians, friends and family members. The new website is www.ImmuneWorks.com.

ImmuneWorks has been conducting research and development of treatments for serious autoimmune lung diseases for the last five years. Over that time, the company attracted the attention of several key investors, raising nearly $4 million. This funding came from groups including Indiana’s 21st Century Research & Technology Fund, BioCrossroads’ Indiana Seed Fund and the IU Medical Group Foundation.

IPF is a devastating lung disease that is progressive and generally fatal. An estimated 128,000 persons in the United States suffer from IPF, with 48,000 new persons diagnosed annually and 40,000 patients dying from the disease each year (source: Coalition for Pulmonary Fibrosis). The number of deaths annually is the same as breast cancer and greater than other cancers such as multiple myeloma. Currently no FDA-approved drug therapies exist for IPF in the United States or Europe.

About ImmuneWorks
Headquartered in Indianapolis, ImmuneWorks was formed in 2006 to develop and commercialize treatments for serious autoimmune diseases of the lung. Led by founders David Wilkes, MD; Michael Klemsz, PhD; Ronald Meeusen, PhD; and President and CEO Wade Lange, the company has made pioneering scientific discoveries that ImmuneWorks is developing as novel therapies and diagnostic products for idiopathic pulmonary fibrosis (IPF) and lung transplantation. In November 2009, the U.S. Food and Drug Administration (FDA) granted orphan drug exclusivity to ImmuneWorks’ lead compound, IW001, a purified bovine Type V Collagen oral solution. In June 2010, the U.S. FDA granted ImmuneWorks approval to begin clinical trials on the compound. Now, in collaboration with Lung Rx, LLC, a wholly-owned subsidiary of United Therapeutics Corporation (NASDAQ: UTHR), ImmuneWorks is conducting clinical trials among IPF patients to test the effects of its new drug candidate. For more information about the company, visit the new website at www.ImmuneWorks.com.