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news.SciClone Pharmaceuticals has posted preclinical data demonstrating that oral SCV-07 retains its immunomodulatory properties and is as effective as the standard injection formulation against tuberculosis in an animal model.
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In the study, which was designed to evaluate the efficacy of an oral formulation of SCV-07 in tuberculosis (TB), mice were infected with M. tuberculosis Erdman. Twelve days after infection, all mice were treated with isoniazid and rifampicin, and some were further treated for five days with either oral or intraperitoneally injected SCV-07 at doses ranging from 0.10ug/kg to 10ug/kg.
Pathological signs of tuberculosis were evaluated 45 days later, and both the oral and injected groups demonstrated significant improvement when treated with 1ug/kg of SCV-07, compared to the control group, which showed minimal changes.
“We are pleased with these data that suggest SCV-07 is orally active, and that the tablet has comparable efficacy to the injection formulation in this animal model of TB,” commented Dr Cynthia Tuthill, chief scientific officer and senior vice president of scientific affairs at SciClone. “We also have a phase I oral comparison clinical study underway to evaluate the oral availability of SCV-07 in healthy human volunteers. Results from this trial are expected in the second half of this year, and, if positive, could substantially broaden the therapeutic potential for SCV-07.”
The data were presented at the 2006 annual meeting of the Federation of Clinical Immunology Societies (FOCIS) in San Francisco, California.