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| |  Cell-Culture Flu Vaccine Safely Boosts Immunity LAVAL, Quebec -- April 25, 1997 -- The results of a Phase I clinical trial on a novel cell-culture-based influenza vaccine demonstrate that it is safe and significantly boosts immunity in healthy volunteers. These positive results will allow BioChem Pharma Inc.’s vaccine subsidiary, IAF BioVac Inc., to proceed to Phase II/III clinical trials, planned to begin in the second half of 1997. The Phase I trial involved 112 healthy adults, half of whom were tested with the new cell-culture-based vaccine and half with Fluviral(R) S/F, the classical egg-based split influenza vaccine manufactured by IAF BioVac Inc. The objectives of the Phase I clinical trial were to demonstrate proof of concept and to evaluate safety and immunogenicity (ability of this new influenza vaccine to elicit an immune response). The goal of the planned Phase II/III trials is to confirm the vaccine's safety and immunogenicity in greater numbers of people, including those at risk, prior to filing for approval and commercialization in Canada. IAF BioVac plans to file a U.S. IND in the second half of 1998 seeking approval to commence U.S. Phase II / III trials for this new vaccine. This new vaccine, produced by an innovative cell-culture-based process, was shown to have an effect on immunity equivalent to Fluviral S/F for both the A-Texas and B-Harbin viral strains of influenza. Respectively 88 percent and 91 percent of the subjects who received the cell-culture-derived vaccine responded to the B- Harbin strain and to the A-Texas strain, while some 77 percent of subjects responded to both strains using the egg-based vaccine. "The results of the Phase I trial clearly show that the vaccine from cell culture is safe and highly immunogenic -- meaning that the subjects in the study responded as we would hope," said the principal investigator, Dr. Scott Halperin from the Clinical Trials Research Center at Dalhousie University and the IWK Grace Health Centre in Halifax, Nova Scotia. While vaccines such as Fluviral S/F are considered highly effective, public health officials from around the world see a need for an alternative. The time required to produce embryonated chicken eggs results in a process that takes six months or longer to manufacture the egg-based vaccine. With the cell culture system, the vaccine would be produced more rapidly and, in the case of a pandemic, could also be manufactured in greater volume. In addition, it could be administered to people allergic to eggs. "Influenza is a significant disease globally, seriously reducing the productivity and quality of life of people around the world. In North America, as many as 25,000 deaths are caused by this disease each year. This cell-culture-based flu vaccine represents a highly innovative advance and is one of a number of technological innovations we are looking at presently," said Dr. Claude Vezeau, President of IAF BioVac. IAF BioVac is the vaccine subsidiary of BioChem Pharma. BioChem Pharma is an international biopharmaceutical company engaged in the research, development and commercialization of innovative products for the prevention, detection, and treatment of human diseases.
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