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July 26, 2005

HCV Treatment Clincal Trial Announcement

Another new treatment being tested against Hepatitis c. The drug companies are scrambling to get a better treatment to market than what is currently available. God bless them!

lobeImmune Initiates Phase 1b Study of GI-5005 for Chronic Hepatitis C Infection

DENVER, July 26 /PRNewswire/ -- GlobeImmune, Inc., a biopharmaceutical company that discovers, develops and manufactures immunotherapeutic products known as Tarmogens(TM) to treat cancer and infectious disease, today announced that it has initiated a Phase 1b study of GI-5005, a Tarmogen for the treatment of chronic hepatitis C infection (HCV). This study is being conducted under an Investigational New Drug application (IND) that was filed with the U.S. Food and Drug Administration in March 2005.

The Phase 1b study is a double-blind, placebo controlled, dose-escalation, multi-center trial evaluating the safety, immunogenicity, and efficacy of GI- 5005, a Tarmogen expressing a NS3-Core fusion protein. NS3 and Core are HCV protein antigens that are expressed in infected cells and are essential for virus replication. GI-5005 has demonstrated robust activity in preclinical models of HCV. Because Tarmogens elicit a balanced immune response that is similar to the response occurring in the minority of individuals who successfully clear primary hepatitis C infection, the Company believes that the GI-5005 Tarmogen may represent a successful approach to treating this difficult disease.

"Hepatitis C is an area of major unmet medical need," said Timothy C. Rodell, M.D., CEO of GlobeImmune. "We are hopeful that GI-5005 will ultimately be able to treat the significant proportion of patients for whom there is currently no effective therapy. This is a significant event for GlobeImmune, as this milestone represents the second Tarmogen product to enter human clinical trials in 18 months and the first clinical trial of a Tarmogen for the treatment of an infectious disease."

Chronic hepatitis C infection, a viral liver disease, is a global health epidemic. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4-5 million live in the United States with an additional 5 million living in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma (liver cancer) and 30% of liver transplants in the United States.

The incidence of new symptomatic infections with hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person that is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control Prevention (CDC) estimate that there are up to 230,000 new hepatitis C infections in the United States every year. Currently, 8,000 to 10,000 deaths each year are attributed to the disease.

ABOUT GLOBEIMMUNE

GlobeImmune, Inc., is an emerging biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. The Company's lead products are in Phase 1 testing for the treatment of hepatitis C infection and for the treatment of cancers of the lung and gastrointestinal tract. Tarmogens are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein antigens that stimulate the immune system against diseased cells.

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July 19, 2005

New National HCV Initiative

It always does my heart well when more information is getting out there to the general public about Hepatitis c.

Health Centers Mobilize Against a 'Silent Killer'
Tuesday July 19, 10:20 am ET
New National Initiative Targets Hepatitis C (HCV) Infection

WASHINGTON, July 19 /PRNewswire/ -- The National Association of Community Health Centers (NACHC), has launched a new initiative against the "silent killer" Hepatitis C (HCV), concentrating efforts through local health care centers and seeking to treat patients before they develop potentially life- threatening symptoms. Among the chronically infected, nearly 70% of patients will develop chronic liver disease, with Hepatitis C being the leading cause of liver transplants in the United States. Kicked off this week in Denver, Colorado, with a national HCV Educational Symposium for project participants, sponsored by The National Association of Community Health Centers (NACHC), the program is rolling out nationally to pilot programs in six U.S. cities.

HCV is described as a "silent epidemic" because most people who are infected will carry the virus for years without knowing it. The disease is responsible for an estimated 10,000 US deaths a year - a number that the Centers for Disease Control and Prevention (CDC) projects will double or triple as people infected decades ago develop more debilitating symptoms.

The Denver symposium lays the groundwork for select health centers throughout the country to develop aggressive clinical strategies against the disease. Working in conjunction with the Denver-based Liver Research Institute (LRI), NACHC will conduct pilot programs in six U.S. cities. After completing the program, health center clinical providers will have the capacity to treat HCV on-site at the patients' medical home. NACHC expects the on-site treatment will lead to improved adherence to the rigorous treatment protocol and enable more health center HCV patients to receive care.

"It is appropriate that the health centers are a staging area for the battle against HCV," stated Tom Curtin, MD, the Vice President for Clinical Affairs at NACHC. "Health centers have compiled an impressive record of success in the prevention and early detection of diseases over the last 40 years. They are uniquely designed for this intervention effort because they are community-based; they understand their patient population and, more importantly, the foundation necessary to conduct outreach and early intervention is already in place."

The Liver Research Institute (LRI) is committed to understanding the natural history of liver disease and the development and evaluation of new therapies. LRI is involved in educational activities to increase awareness and improve outcomes.

"We are excited to be working with NACHC to bring together both clinical expertise and practical tools for health centers in the fight against Hepatitis C," said Stephen Steinberg, MD, Medical Director of the Liver Research Institute.

The second phase of the project includes a three day training program guided by local HCV experts. The national HCV initiative provides select health centers with the state-of-the-art tools and clinical training to expand HCV early intervention and treatment. Each health center will receive clinical education and training, as well as resources to help integrate a treatment strategy in their existing clinical setting. Clinical teams from participating health centers include those from Miami, FL, Houston, TX, New York City, NY, Baltimore, MD, Los Angeles, CA, and Denver/Fort Lupton, CO.

The launch of the initiative comes as the CDC estimates that nearly four million Americans are infected by HCV, with new infections expected to grow at a rate of 30,000 a year. HCV sufferers can develop liver diseases that impair function, such as liver cancer or cirrhosis -- conditions that are ultimately fatal.

Health centers are the medical home to nearly 15 million Americans, many of whom are low-income and/or uninsured and at high risk for HCV infection. For more information about health centers or NACHC, visit http://www.nachc.com.

Established in 1971, NACHC is a non-profit organization whose mission is (1) to represent the interests of federally supported and other federally qualified health centers and (2) to serve as an information source concerning issues of health care for poor and medically underserved populations in the United States.

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