Univax Biologics Inc.'s polyclonal immunoglobulinHyperGAM+CF contains sufficient quantities of antibodies tobegin testing the compound for treatment of lung infections incystic fibrosis patients, the company reported at theInterscience Conference on Antimicrobial Agents andChemotherapy (ICAAC) in New Orleans.
HyperGAM+CF is derived from the plasma of donors immunizedwith Univax's HyperVAX+CF vaccine. In the data presented atICAAC, 88 of 189 plasma donors immunized with a dose of thevaccine produced antibodies specific for mucoid pseudomonasbacteria, which causes lung infection in CF patients. "Over 75percent of responders developed acceptable opsonic (killing)titers within four weeks, with all responders reaching thatlevel within six weeks post-vaccination," the companyreported.
Univax's associate director of clinical research, Mark Thornton,noted that the "opsonic activity of HyperGAM+CF against themucoid pseudomonas was seven-to-fifteen-fold that ofstandard immunoglobulin."
Univax said that "up to 90 percent of CF patients eventuallyexperience obstructive bronchitis" associated with lunginfections, and a majority of infected patients "are unable toproduce antibodies capable of killing" bacteria. Thesefrequently die of pulmonary failure secondary to the chronicinfections.
The company plans to begin preparatory studies for Phase IItesting of the antibody product this quarter and to begin thetrials by mid-1994. Trial subjects will initially be CF patientswith acute exacerbation of pseudomonas infections. A safetyand pharmacokinetics study will be followed with a 60-patienttrial designed to assess bacterial load, pulmonary function andquality of life parameters. The studies will be conducted atStanford University Medical Center.
Univax (NASDAQ:UNVX) of Rockville, Md., is developingHyperGAM+CF with Genzyme Corp. (NASDAQ:GENZ) under anagreement announced in August. Univax will manufacture theantibody product, as well as other products to treat lunginfections associated with CF, and Genzyme will market them.-- Brenda Sandburg
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