MARTINSRIED, Germany and SAN DIEGO, Sept. 16, 2002 (PRIMEZONE) -- Apovia AG and its wholly owned subsidiary Apovia Inc. today announced the initiation of its first human Phase I clinical trials for its candidate malaria vaccine, MalariVax(R). The trials will evaluate the safety and immunogenicity of MalariVax(R).
The University of Maryland School of Medicine Center for Vaccine Development is conducting the Phase I clinical trial under an IND filed with the Food and Drug Administration (FDA) by the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases' (NIAID) Division of Microbiology and Infectious Diseases (DMID).
A second clinical trial has been initiated under a Clinical Trial Exemption (CTX) filed by the Company with the Medicines Control Agency (MCA) in the United Kingdom. Simbec Research, a clinical research organization (CRO) based in Merthyr Tydfil, South Wales, is conducting this Phase I study.
"The initiation of our first Phase I clinical trials in the U.S. and in the U.K. for our malaria vaccine candidate, MalariVax(R), represents a significant milestone for the Company," stated George B. Thornton, Managing Director, Apovia Inc. and head of R&D. "The generous support and collaboration of the National Institutes of Health and the Malaria Vaccine Initiative, as well as our scientific and clinical collaborators at New York University and Advanced Biologics, LLC, have been invaluable in achieving this first major step towards the development of our malaria vaccine concept," said Thornton.
"The clinical trial of Apovia's, MalariVax(R) is an important step forward, and we believe our support for this technology will help advance malaria vaccine development," said Regina Rabinovich, MD, Director of the Malaria Vaccine Initiative. "We commend Apovia for stepping up to the plate and undertaking the challenge of developing a vaccine so badly needed in so much of the world."
Malaria is a parasitic infection transmitted through the bite of the Anopheles mosquito. The World Health Organization estimates that between 300 and 500 million people are currently infected, and 2.3 billion are at risk. More than two million people or more die of malaria every year, and over half of these deaths are of children in subSaharan Africa.
MalariVax(R) is based on Apovia's proprietary CorVax technology. CorVax is a potent antigen delivery and carrier platform that stimulates high levels of antibody production and primes cellular immunity. The Company believes that its CorVaxbased vaccines' anticipated safety profile, potency, competitive cost and ease of manufacture will enable it to address diseases of global significance.
Apovia is a biopharmaceutical company focused on the prevention and treatment of infectious diseases through vaccines based on its CorVax carrier platform. The Company conducts research at its headquarters in Martinsried, Germany and at its subsidiary Apovia Inc. in San Diego, California and produces clinical trial material at its pilot GMP manufacturing facility in Coralville, Iowa. Apovia's product candidates under development include vaccines against malaria, influenza, otitis media and bacterial meningitis.
Notes for Editors:
Advanced Biologics LLC: Advanced Biologics LLC is a full service clinical research organization (CRO) located in Lambertville, NJ. Advanced Biologics LLC offers global clinical development support for Phase IIV clinical programs and has coordinated numerous IND and NDA submissions. For further information visit website at: www.advbiol.com.
Malaria Vaccine Initiative: MVI was created in the belief that the technology and knowledge needed to create a malaria vaccine exist, but that market forces alone will not lead to the aggressive development of a vaccine needed only by developing countries. Program for Appropriate Technology in Health (PATH) established the Malaria Vaccine Initiative through a $50 million award by the Bill & Melinda Gates Foundation. PATH is an international nonprofit organization whose mission is to improve health, especially the health of women and children. For further information on MVI, visit the Web site at: www.malariavaccine.org.
Medicine Control Agency: The U.K. Medicines Control Agency (MCA) is an Executive Agency of the Department of Health. Its primary responsibilities are: to protect and promote high standards of public health through the regulation of the quality, efficacy and safety of human medicines; and to work for the benefit of the wider interests of the U.K. economy. The Medicines Control Agency's (MCA) primary objective is to safeguard public health by ensuring that all medicines on the U.K. market meet appropriate standards of safety, quality and efficacy. Safety aspects cover potential or actual harmful effects; quality relates to development and manufacture; and efficacy is a measure of the beneficial effect of the medicine on patients.
National Institute of Allergy and Infectious Diseases: The National Institute of Allergy and Infectious Diseases (NIAID) is a component of the National Institutes of Health (NIH). NIAID conducts and supports research that strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten hundreds of millions of people worldwide.
Simbec Research: Simbec is one of Europe's foremost Clinical Research Organizations (CROs) that has provided clinical research services to the international pharmaceutical and biotechnology industry for over twentyfive years. Simbec has its headquarters and main clinical pharmacology unit in South Wales, in the United Kingdom with clinics in Israel, and Spain and offices in France, Japan, India and Central and Eastern Europe. (www.simbec.co.uk)
University of Maryland School of Medicine Center for Vaccine Development (CVD): The Center for Vaccine Development has earned an international reputation for genetically engineering and testing vaccines against cholera, typhoid and malaria. Based in the School of Medicine at the University of Maryland, Baltimore, the Center was established in the 1970's as one of the first facilities to evaluate vaccines in community volunteers. It is the only university vaccine center in the world engaged in the full range of vaccinology: from basic science through vaccine development, clinical evaluation and field studies. For further information visit website at: www.medschool.umaryland.edu/cvd/SOM.HTML.
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