Phase I clinical trial results on Cambridge Biotech Corp.'svaccine adjuvant QS-21 have shown that a vaccine containingthis adjuvant is both safe and active in humans.

Philip Livingston, a researcher at the Memorial Sloan-KetteringCancer Center in New York, reported these results Saturday at ameeting of the New York Academy of Sciences on SpecificImmunotherapy of Cancer with Vaccines.

Livingston assessed methods of augmenting antibody responseto melanoma ganglioside vaccines combined with variousadjuvants in 30 post-surgical melanoma patients. Six patientsreceived a putative vaccine consisting of Stimulon, theWorcester, Mass., company's QS-21 adjuvant, in combinationwith a melanoma-specific antigen -- ganglioside GM-2 --prepared by Biomira Inc. of Edmonton, Alberta. The otherpatients received ganglioside formulations containing otheradjuvants, including BCG. (This ganglioside is not a product thatBiomira is taking into clinical trials right now, according to JaneJack, Biomira's manager of investor relations.)

The QS-21-containing vaccine "produced longer-lasting IgMantibodies of four- to eightfold greater titer" than the vaccinecontaining the BCG adjuvant "and IgG antibodies capable ofmediating both complement dependent cytotoxicity andantibody dependent cell mediated cytotoxicity against GM2-expressing melanoma cells," Livingston reported.

"This clinical trial marks the first use of Cambridge Biotech'sQS-21 adjuvant in humans," said Gerald Beltz, director ofresearch. But more trials are on the way, some starting in thefirst half of this year, Beltz told BioWorld. These will come fromone or more of Cambridge Biotech's (NASDAQ:CBCX)collaborations in vaccine development. Cambridge Biotech hasan agreement with SmithKline Beecham on 25 differentvaccines, with Genentech on an AIDS vaccine, and with PasteurMerieux on an influenza vaccine, Beltz explained. -- JenniferVan Brunt

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