Cangene has entered a collaborative research and development agreement with Acambis plc to develop and manufacture a hyperimmune globulin for treating and preventing infection by West Nile virus (West Nile Immune Globulin; WNIG). The companies will share development and funding for the project. Acambis will provide its investigational ChimeriVax-West Nile vaccine, qualified product-assay technology and testing for efficacy of the WNIG. Cangene will collect plasma, and develop and manufacture the product using its established manufacturing process in its Winnipeg facility.
A hyperimmune globulin against West Nile may be used to treat people who have become infected with the virus and to give immediate protection to immunocompromised individuals, such as the elderly, whose immune systems may not be able to generate a sufficient immune response.
"West Nile spread across North America at an astonishing rate and has rapidly established itself as a public health concern. With operations in Manitoba and Ontario we are acutely aware of the threat of mosquito-borne infections and we believe that hyperimmune technology is well suited to meet the challenge," said Dr. John Langstaff, president and CEO of Cangene Corporation.
West Nile virus is a flavivirus spread by mosquitoes that have fed on the blood of infected birds. West Nile virus is closely related to the viruses that cause dengue fever, yellow fever and St. Louis encephalitis. The first recorded outbreak in North America occurred in New York City in 1999. In Canada, the virus was first confirmed in birds in Ontario in 2001 with the first human case being confirmed in Ontario in September 2002. In 2002, there were 4156 reported cases of West Nile infection, including 284 deaths, across 44 states in the U.S. The Washington Post (Aug. 7, 2003) quoted Dr. Julie Gerberding, Director of the U.S. Centers for Disease Control and Prevention (CDC) as saying "(incidence this year) indicates we are starting the epidemic with more cases than last year" and warning of "a great number of infected people." West Nile virus is currently present in six Canadian provinces - New Brunswick, Quebec, Ontario, Manitoba, Saskatchewan and Alberta. In the U.S., 1764 cases had been reported to the CDC from 34 states as of September 2, 2003.
An estimated one fifth of infected people will develop mild flu-like symptoms, including fever, headache, body aches, and sometimes rash and swollen lymph nodes; 1 in 150 of those infected will develop a severe infection including high fever, inflammation in the brain and possibly permanent neurological effects or death. Persons over 50 years of age, particularly the elderly, have the highest risk of severe disease.
Acambis' vaccine, ChimeriVax-West Nile, has been developed using the company's proprietary ChimeriVax technology and its chosen vaccine candidate has successfully undergone pre-clinical testing to establish its safety profile and effectiveness at protecting against West Nile virus. Acambis plans to begin a Phase I trial of ChimeriVax-West Nile shortly. The advantages of ChimeriVax vaccines include a good safety profile, the ability to induce protection within a few days after a single dose and long-lasting immunity without the need for booster doses.
Hyperimmune globulins are highly purified antibodies made from specialty human plasma used for therapeutic purposes. Such concentrated antibodies react with a specific infectious agent and can confer immediate protection against it. They differ from vaccines in that they do not require the patient's own immune system to develop immunity.