
PRNewswire October 30, 2000 FRAMINGHAM, MA, October 30 /PRNewswire/ -- Genzyme Transgenics Corporation ("GTC") (Nasdaq: GZTC) announced today that a malaria vaccine protein under development using GTC's technology has elicited protection against malaria in primates. The scientific paper describing this study will be presented today at the 49th Annual Meeting of the American Society of Tropical Medicine and Hygiene in Houston, Texas. GTC's technology produced a version of the MSP-1 (Merozoite Surface Protein 1) protein that successfully protected Aotus nancymai monkeys in a preclinical vaccine study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). "This study result successfully demonstrates that recombinant proteins obtained from the milk of transgenic animals in high yield can elicit protective immunity in a simian model of malaria immunity," stated Dr. Harry Meade, Vice President of Research of GTC. "Thus, transgenic animal production may have significant technical as well as economic advantages for the manufacturing of vaccines against malaria." Although malarial parasite proteins can be produced in other recombinant systems, it is in very limited quantities or in forms that may not induce the necessary immune response. The NIAID and GTC established a CRADA (Cooperative Research and Development Agreement) to evaluate the feasibility of developing animals capable of producing recombinant versions of MSP-1 in their milk. To express the MSP-1 protein at high quantities, GTC's scientists modified its gene sequence while conserving the overall amino acid sequence of the protein. The MSP-1 protein has been expressed at 2-4 mg/ml in the milk of mice that have incorporated this gene sequence. This rate of production is substantially higher than is typically achieved in other recombinant systems. "GTC is proud of this achievement and the people who have contributed to the development of a malaria vaccine," stated Sandra Nusinoff Lehrman, M.D., President and Chief Executive Officer of GTC. "We believe that MSP-1 is an important protein to advance into further studies." The malarial parasite enters the bloodstream from the bite of an infected mosquito. After an initial period of development in liver cells, parasite forms known as merozoites are released back into the bloodstream and initiate the blood stage of the infection. During the blood stage of the infection, malaria parasites multiply in red blood cells of infected individuals. These red cells eventually burst, releasing merozoites that then invade other red blood cells to propagate the infection. MSP-1 is a protein associated with the merozoite stage of the malaria life cycle. A vaccine based on this protein would be expected to interfere with the development of red cell infection, resulting in protection against malaria. The World Health Organization (WHO) estimates that 300-500 million people are infected annually worldwide, with over one million malaria-attributable deaths each year, mostly among infants and children. Mosquitoes that transmit the disease have become resistant to insecticides, and the most lethal form of the parasite, P. falciparum, has become resistant to the major drug used to treat the disease, chloroquine. It is widely recognized that development of an effective malaria vaccine would constitute a significant global public health advance. Genzyme Transgenics Corporation is a leader in developing medicines from the milk of specially bred animals, primarily goats. Many of the medicines under development are monoclonal antibodies and immunoglobulin fusion proteins or other therapeutic proteins. To date, GTC has formed more than a dozen collaboration agreements which provide for production of specific proteins. Additional information is available on the GTC web site, http://www.transgenics.com. This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements about the potential benefits of MSP-1, anticipated advantages of transgenic production over other forms of recombinant technology, and the impact of malaria on world health. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in Genzyme Transgenics Corporation's prospectuses and 1999 Annual Report on Form 10-K, as filed with the Securities and Exchange Commission, including the uncertainties associated with additional studies, the risks and uncertainties of developing purification and production processes, and the risks and uncertainties associated with dependence upon the actions of government and regulatory agencies.
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