Meridian Bioscience, Inc. Announces the Commencement of Phase I/II Clinical Trials of Parvovirus B19 Vaccine
CINCINNATI--(BUSINESS WIRE)--Aug. 28, 2007--Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced the commencement of a Phase I/II Clinical Trial for a Parvovirus B19 Vaccine manufactured by its wholly owned subsidiary, Meridian Life Science, located in Memphis, Tennessee. The Investigational New Drug (IND) Application for the Parvovirus B19 Vaccine was a collaborative effort between Meridian Life Science and two branches of the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI/NIH), and the National Institute of Allergy and Infectious Diseases (NIAID/NIH). The Phase I/II Clinical Trial will be conducted at three of NIAID/NIH's Vaccine Testing and Evaluation Units (VTEU) on behalf of the NHLBI/NIH. The VTEUs are the Cincinnati Children's Hospital, the Baylor College of Medicine, and the University of Maryland, Baltimore. The trial has been initiated and it will evaluate the safety and immunogenicity of the Parvovirus B19 Vaccine in healthy adult human volunteers.
In October 2003, Meridian was awarded a contract to manufacture a recombinant DNA Parvovirus B19 Vaccine for the NHLBI/NIH. The technology was invented by Dr. Neal Young, Chief of the Hematology Branch at the NHLBI/NIH. Process Development and cGMP manufacturing of the Parvovirus B19 Vaccine took place at Meridian's life science manufacturing facility located in Memphis, Tennessee. Upon successful completion of the Phase I/II Clinical Trials, Meridian Life Science plans to continue its collaboration with the NIH and conduct Phase II and Phase III Clinical Trials. Meridian Life Science will be responsible for the manufacture of the vaccine, and will assume a greater role with respect to the regulatory aspects of the vaccine.
In July 2005, Meridian was awarded the exclusive global license for the technology related to the Parvovirus B19 Vaccine from the NIH. The license provides Meridian with exclusive and global rights to utilize the patented technology to develop, manufacture and market the Parvovirus B19 Vaccine for Fifth Disease, Transient Aplastic Crisis (TAC), and Hydrops Fetalis.
According to the NHLBI/NIH, the Institute has a long-standing interest in Parvovirus B19, an important pathogen affecting humans. Parvovirus B19 infection is common among children and adults and is often asymptomatic. Parvovirus B19 infection can result in serious and occasionally fatal hematologic diseases in susceptible patients. In sickle cell disease and other hereditary and acquired hemolytic anemias, acute Parvovirus B19 infection results in TAC, in which hemoglobin levels fall precipitously, anemia becomes life threatening, and congestive heart failure may ensue. Parvovirus B19 is also the cause of "Fifth Disease," a highly contagious childhood infection. Children with Fifth Disease act as a reservoir for the virus and can infect seronegative women who are pregnant leading to transmission of the virus to the fetus causing severe anemia, congestive heart failure, and death in utero or at birth (also known as Hydrops Fetalis). Based on the current literature, up to 40% of all pregnant women are seronegative and susceptible to Parvovirus B19 infection.
Richard L. Eberly, President, Meridian Life Science, Inc., commented, "We are pleased to have expanded our collaboration with the NIH to include the initiation of Phase I/II Clinical Trials for the Parvovirus B19 Vaccine. The combination of Meridian's scientific and technical capabilities with the NIH's proprietary technology and clinical research expertise will hopefully lead to an important and much needed vaccine for the prevention of disease caused by parvovirus infections."
Dr. Preston Dorsett, Founder and President, Emeritus, Viral Antigens, Inc., commented, "The manufacturing process uses recombinant protein technology to generate non-infectious Parvovirus B19 viral particles for use in the vaccine. Meridian is developing processes at a scale sufficient for commercialization of the vaccine."
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian's diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company's shares are traded through NASDAQ's Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, President, 513-271-3700
SOURCE: Meridian Bioscience, Inc.