Results of Phase IB trials of the anti-AIDS drug GLQ223 showedthat the purified form of trichosanthin is safe and well-tolerated, and clinically active according to severalimmunologic markers, Genelabs Technologies Inc. said Monday.
Markers used to chart the clinical course of GLQ223 were asignificant, dose-related increase in T-3 white blood cells,which include CD4 and CD8 cells, and elevations in levels ofbeta-2-microglobulin, a change believed to indicate destructionof HIV-infected macrophages.
Ken Gorelick, vice president of medical and regulatory affairs atthe company (NASDAQ:GNLB), said GLQ223 is the only drug heis aware of that affects any HIV-infected macrophage or CD4cell, whether it's activated or not.
Both changes in immune markers were reversed when thedrug was withdrawn from the 21 patients with AIDS or AIDS-related complex who had received four weekly infusions.
The Redwood City, Calif., company purifies alpha-trichosanthin,the same active ingredient in Compound Q, which has beenused in underground tests in AIDS patients. Compound Q hadbeen associated with severe neurologic reactions in a few of thepatients tested, said Gorelick, but the company's trial ofGLQ223 did not produce these consequences.
Reactions observed by Genelabs included muscle and jointpains that could be severe, but were controlled by non-prescription pain killers and tended to abate over the course ofGLQ223 therapy, Gorelick told BioWorld.
A Phase II trial, begun in September, will probably conclude bythe end of next year. GLQ223 will be both compared with andcombined with AZT.
Genelabs stock closed at $8.88, up $1.25, on Monday. -- RobertaFriedman, Ph.D.
(c) 1997 American Health Consultants. All rights reserved.