INFORMATION
For Trade Press Release Only
May 14, 2009
Contact: 513.271.3700
Richard L. Eberly
MERIDIAN LIFE SCIENCE TO PRESENT AT BIO 2009: DEVELOPMENT OF A RECOMBINANT HUMAN PARVOVIRUS B19 VACCINE TO PREVENT TRANSIENT APLASTIC CRISIS
Meridian Life Science, Inc.® (MLS) will be hosting a presentation at the BIO 2009 at the BIO 2009 Annual Meeting in Atlanta on the Development of a Recombinant Human Parvovirus B19 (HPVB19) vaccine to prevent Transient Aplastic Crisis (TAC). This presentation will be given at the Genetic Engineering News Theater located at booth # 5924 on Wednesday, May 20th, at 3:00pm EDT. This presentation will cover the manufacturing and clinical development of this vaccine being developed in collaboration with the National Heart Lung and Blood Institute (NHLBI) and the Division of Microbiology and Infectious Diseases at NIH.
HPVB19 is a member of the family parvoviridae and genus parvovirus. These small DNA viruses replicate autonomously and destroy principally human erythrocyte precursors. HPVB19 has been shown to be the causative agent of a variety of conditions, ranging from asymptomatic infection, erythema infectiosum [(EI), also “fifths disease”] in children, arthritis in adults, TAC in patients with hemolytic anemia, chronic anemia in immunodeficient patients, and hydrops fetalis leading to spontaneous abortion in infected pregnant women. While originally developed for the Sickle Cell Population, this vaccine has the potential to prevent life-threatening Parvovirus B19 infections in cancer patients on chemotherapy (or other treatment regimens rendering them immunocompromised) and in organ transplant patients on immunosuppressive therapies. The global health care burden of HPVB19 is not fully known but is suspected to be significant in developing countries. Immunization is a promising strategy to prevent serious parvovirus infection in high-risk groups.
A recombinant HPVB19 vaccine has been invented by Dr. Neal Young and investigators at the NHLBI. Initial clinical development with the vaccine showed development of neutralizing antibodies in healthy adults. MLS subsequently licensed the rHPVB19 vaccine technology from the NIH and is assisting the NIH with manufacturing of the vaccine and aspects of clinical development. The vaccine is a virus-like particle vaccine consisting of two viral proteins (VP1 and VP2) in separate baculovirus vectors that are co-infected into Spodoptera frugiperda (Sf9) cells and that, upon expression, self assemble at the appropriate ratio into immunogenic but non-infectious virus-like particles. The presentation will be given by Dr. Daniel Shelly, Director of Business Development. The clinical development plan will be discussed along with estimates of the global disease burden caused by the HPVB19 virus.
ABOUT MERIDIAN LIFE SCIENCE:
Meridian Life Science, Inc. provides contract R&D, process development, and clinical cGMP biomanufacturing of vaccines, viral challenge materials, gene therapies, virus-like particles, and recombinant proteins at its contract biopharmaceutical manufacturing facility in Memphis, TN. This business focuses on materials that will be used in Phase I and II clinical trials that are intended for use as "injectables." As such, they are produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA. With 25 years of cell culture experience, virus production, purification, assay development and quality, Meridian has become a leader and trusted partner for Phase I-II cGMP biomanufacturing solutions. Meridian also supplies critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets. Meridian Life Science services its customers from three primary manufacturing operations in Memphis, Tennessee; Saco, Maine; and Boca Raton, Florida. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian’s website address is www.meridianlifescience.com.
FOR ADDITIONAL INFORMATION CONTACT:
Daniel A. Shelly, Ph.D., MBA, Director of Marketing and Business Development, 513.271.5266.