BUSINESS WIRE; Thursday, March 12, 1998, 6:25 am PST
The first abstract reports on laboratory data from a pathogenesis-based Phase II clinical study conducted on 18 patients with HIV disease treated with WF10. As seen in an earlier study, administration of the drug was safe and without serious adverse clinical or laboratory events. While some immune modulators have been shown to increase HIV RNA viral loads, with WF10 treatment there was no change in viral load after 47 days.
Previous investigators have demonstrated that HIV infection is characterized by a state of inappropriate, persistent immune activation and that several markers, including CD38+ cells, correlate with the stage and progression of the disease. The researchers in this study found that treatment with WF10 led to down-regulation of this immunologic activation marker and confirmed previous observations of up-regulation of macrophage phagocytosis. In addition, the lymphocyte pool appeared to be reconstituted with CD8+ T cells, potentially capable of responding to opportunistic infections. This suggests that WF10 may be useful for treating some of the symptoms associated with HIV disease.
Further potentially beneficial, immune-modulation was seen in the abstract on AIDS dementia. In an earlier study of AIDS dementia patients, this same research group found markedly elevated levels of intracellular macrophage TNF-alpha, a known neurotoxin. In this new study they found that WF10 treatment of blood from such patients showed a marked down-regulation of macrophage TNF-alpha expression. This suggests that WF10 may be useful in the treatment of AIDS-related dementia.
A link to understanding some of these immune-modulating changes of the immune system may be found in the third abstract on antigen presentation. The researchers demonstrated that WF10 could be a potent inhibitor of antigen presentation, an important step in activating the immune system. At their conference presentation, the authors will propose a model wherein this inhibitory effect might down-regulate the overactive T-cell response that characterizes HIV disease progression.
"These presentations represent a very significant stage in the development of WF10," said Rebecca Keeler, President and CEO of Dimethaid Research. "The findings show some remarkable attributes of WF10 as a platform immune modulator and suggests it could have great benefit for people living with AIDS."
Oxo Chemie AG is the developer and holder of the patent rights to WF10. Dimethaid Research holds a 20 percent interest in Oxo, as well as all Canadian distribution rights to WF10. Dimethaid Research is a pharmaceutical company engaged in the development and commercialization of innovative therapeutic products which work with the body's own healing mechanisms.
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Note to Editors: The three abstracts are available on our web site: www.dimethaid.com
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CONTACT: Dimethaid Research Inc. Peter Block, 905/415-1446 e-mail: pblock@dimethaid.com
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