U.S. Patent Approved for Conjugate Vaccine Against Group B Streptococcus
COLUMBIA, Md., June 8 /PRNewswire/ -- North American Vaccine (Amex: NVX) announced today that the United States Patent Office approved a U.S. patent for a unique group B streptococcal (GBS) vaccine which incorporates a GBS polysaccharide conjugated to a C protein alpha antigen or beta antigen of GBS. Pre-clinical studies indicate that these antigens are effective carrier proteins, conferring long-lived memory immune responses to the different GBS polysaccharide serotypes.
A number of organizations have expressed interest in working with the Company on this project. The Company estimates the annual market potential for GBS vaccines to be $500 million for the U.S. and Europe. There are currently no approved vaccines for the prevention of group B streptococcal infections.
Dr. Randal Chase, Chief Executive Officer and President of North American Vaccine, stated "Our GBS vaccine is another example of the rich product pipeline at North American Vaccine. A collaboration may be the fastest and most reliable way for us to deliver the benefits of this exciting product to the market."
The National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health, and the Company are collaborating in further evaluation of GBS conjugate vaccines. The Company is targeting the end of the first half of 2000 to begin clinical testing of its tetravalent GBS conjugate vaccine. The NIAID conducted proof-of-principal clinical studies in 1996 for a GBS conjugate vaccine manufactured using the Company's technology. These trials demonstrated that the vaccine is generally safe and produces protective antibodies.
Group B Streptococcus is the most common cause of serious infections in newborns and young infants. Newborns are usually infected with GBS from the mother during the delivery process. Disease occurs principally during the first three months of life and can result in serious complications, including blindness, mental retardation, pneumonia, sepsis and permanent brain damage from meningitis. There are an estimated 8,000 - 12,000 cases of invasive GBS infection in neonates each year in the United States with a mortality rate of approximately 5% - 8%. GBS disease is also a prominent cause of peripartum maternal infections, causing an estimated 50,000 cases annually that can lead to serious morbidity and mortality. Since there is no vaccine for the prevention of GBS disease, the Centers for Disease Control and Prevention has issued guidelines for detecting and treating GBS infections in pregnant women. These guidelines, which have been adopted by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, include screening during the third trimester and, for those who are infected or identified as being at high risk, a course of intravenous antibiotics is recommended during and post labor. While this approach has reduced the number of neonates infected with GBS, it has not eliminated disease. In addition, this approach may promote the growth of antibiotic resistant strains of GBS and other bacteria. |
