Hepavaxx C
Product Overview
HepaVaxx C is a Chimigen™ therapeutic vaccine developed at the ViRexx research labs for the treatment of chronic hepatitis C viral infections.
HepaVaxx C consists of a recombinant chimeric molecule containing the elements of both hepatitis C viral antigen and a xenotypic antibody. The molecule is designed to target a particular set of cells that play a dominant role in the body's immune system. Plans are in place to carry out a pre-clinical evaluation of the vaccine candidates using specialized assay systems developed by ViRexx. The selected Chimigen™ vaccine is expressed in insect cells which produce the desired product in large quantities under appropriate culture conditions.
Market Overview
| Globally | US | |
| Prevalence | 170 million | 2.7 million |
| Target Market | 3-4 million | 25,000 |
Sources: World Health Organization Fact Sheet WHO/164 - October (2000) Med AdNews, August 2002.
Source: World Health Organization (2000)
The World Health Organization estimates that 170 million persons are chronically infected with HCV (more than four times as many as infected with HIV) and 3 to 4 million persons are newly infected each year.
(Source: WHO Fact Sheet WHO/164 - October 2000.)
Approximately 75% to 85% of individuals infected with HCV will develop a chronic infection of which approximately 15% to 20% will develop chronic liver disease progressing to cirrhosis. Between 1% and 5% of people with chronic infections will develop liver cancer over a period of 20 to 30 years.
An estimated 4 million people have been infected with HCV in the US , of whom 2.7 million are chronically infected. According to the US Center For Disease Control and Prevention (the "CDC"), new infections in the US have dropped from approximately 240,000 annually in the 1980s to less than 25,000 in 2001. This is largely due to the availability of a diagnostic antibody test, which was introduced in 1990 to screen and eliminate HCV-infected blood from the nation's blood supply. (Source: Centre for Disease Control Hepatitis C Fact Sheet (2003).)
Since 1990, all blood in the US has been screened for the presence of the virus, thus eliminating almost all cases of transmission through transfusion. While this screening test has also been adopted by many other industrialized nations, the rest of the world is still at risk from transfusions as well as the other common routes of transmission (especially contaminated needles). Without blood screening, many if not most carriers have no idea that they are infected, or that they should take precautions against infecting others.
While the incidence of infection in the US has decreased since the 1980s, the rate of deaths attributable to HCV continues to increase as people infected decades ago begin to succumb. According to the CDC, 8,000 to 10,000 people currently die each year from HCV-related liver disease. HCV continues to be the number one reason for liver transplants. The CDC has predicted that the death toll will triple by the year 2010 and exceed the number of US deaths due to AIDS. In addition, HCV is now the most common blood-borne infection in the US .
According to Hepatitis Central , over the next 10 to 20 years chronic HCV is predicted to become a major burden on the health care system as many patients who are currently asymptomatic will progress to end-stage liver disease and cancer. Predictions in the US indicate that there will be a 60% increase in the incidence of cirrhosis, a 68% increase in hepatoma, a 279% increase in hepatic decomposition, a 528% increase in the need for transplantation, and a 223% increase in liver death rate.
Presently, the only therapy for hepatitis C infection is Interferon and Ribavirin. However, this combination is expensive, has substantial side effects and is effective in approximately 30% of selected patients. The epidemic proportions of HCV infection, the limited efficacy and expensive nature of approved therapeutics, the high cost of liver transplants (about $250,000 each) and the huge burden on the healthcare system (about $600 million in 1998, just in medical and work-loss costs), all point out the need for prophylactic vaccines and new therapies to treat the disease. (Source: Health Canada News Release, September 18, 1998 and Fields Virology (2000) Volumes I and II (Fourth Edition).)