Univax Biologics Inc. and Genzyme Corp. have started Phase I/IIhuman safety trials of HyperGAM+CF, a specific polyclonal antibodyproduct designed to prevent and treat lung infections in cystic fibrosis(CF) patients.Univax of Rockville, Md., and Genzyme of Cambridge, Mass., hopethat HyperGAM+CF will give CF patients an immune defense againstmucoid strains of the bacteria, Pseudomonas aeruginosa. It is the firstproduct Univax has taken from the development-stage to clinical trials.Cabot Caski, chief financial officer for Univax, told BioWorld that thetrial will consist of five arms with four patients each: a standard gammaglobulin arm and a low dose of HyperGAM+CF, two moderate dosesand a high dose.Under terms of their agreement reached last summer, Genzyme willreimburse Univax, through milestone payments, about $5 million thatUnivax already had put into the program. The companies now willshare development costs, Univax will be responsible for manufacturingand Genzyme for marketing, Caski said. Profits would be shared at anundisclosed percentage. - Jim Shrine
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