PARIS Biovector Therapeutics¿ nasally administered influenza vaccine has successfully completed a Phase I clinical trial, which entailed the administration of a trivalent vaccine using the company¿s proprietary Biovector Light delivery system. The use of a nasal spray is designed to trigger the production of antibodies at the nasal mucus level as well as at a systemic level, and the company maintains that this ¿double barrier of protection has effectively demonstrated a more complete immune response.¿
The randomized, double-blind trial comparing the vaccine with a placebo was carried out on a cohort of 60 healthy patients by the University of Dalhousie Clinical Research Center, at the IWK-Grace Health Care Center, in Halifax, Nova Scotia. The vaccine, which consisted of the three viral strains recommended by the World Health Organization for the 1997 to 1998 influenza season, was administered twice, 28 days apart, and demonstrated satisfactory tolerance as well as a fourfold-plus increase in patients¿ immunoglobulin (Ig) systemic IgG and mucus IgA.
Emile Loria, CEO of Toulouse-based Biovector Thera peutics, said these initial results are ¿very encouraging.¿ The company is developing the product with BioChem Vaccins, a subsidiary of Canada¿s BioChem Pharma. Loria explained that, while this trial entailed the use of antigens traditionally cultured on eggs, ¿other clinical trials to be carried out with antigens cultured on cells using a BioChem Pharma process could help our two companies establish new standards for influenza vaccines.¿
Phase II trials of this first vaccine could take place in 1999, probably in Canada and the U.S., but that depends on BioChem Pharma. In June, it signed a worldwide development and marketing agreement for the product with SmithKline Beecham plc, of London, giving the latter marketing rights in all countries outside North America, while BioChem has exclusive rights for Canada. The two companies are to set up a joint venture to market the product in the U.S.
As for Biovector, its strategy is to continue focusing on upstream development for the time being. The nasal spray is one of several novel drug delivery systems it is developing, four of which it has patented for the delivery of various antigens and genes. BioChem Vaccins became Biovector¿s first pharmaceutical partner when it signed an agreement in April for the co-development of six vaccines utilizing the French company¿s delivery systems.
The other pathologies being targeted by Biovector are cancer, certain infectious diseases, meningitis, hemophilia and AIDS treatments for which are all at the preclinical stage.