Shaman Pharmaceuticals Inc. announced Monday that theresults of its challenge study of respiratory syncytial virus(RSV) infection reinforced the safety profile of the company'santiviral compound Provir, which is derived from a medicinalplant.
Shaman (NASDAQ:SHMN) president and chief executive officerLisa Conte presented the results at the S.G. Warburg EmergingPharmaceuticals Conference in London.
Shaman of South San Francisco, Calif., had already conducted aPhase I safety study of Provir in healthy volunteers. Thecompany used a "typical challenge study design, copied frominfluenza studies," for the latest safety trial, Conte explained.
The challenge study, conducted at the University of RochesterSchool of Medicine in Rochester, N.Y., was performed on adultswho were experimentally infected with RSV, followed within24 hours by Provir or placebo. Of the 32 patients enrolled, 11received about 2 milligrams of Provir per day per kilogram ofbody weight, 11 received a Provir dose of 10 milligrams, andthe other 10 received a placebo.
Although RSV is generally thought of as a childhood disease,"the virus used to induce disease in this study produced a lowincidence of infection (in adults)," commented John Treanor, theclinical investigator on the trial. "This low level of infection andthe small number of patients who showed measurablesymptoms did not allow us to detect potential significantbenefit in the treated groups. However, the drug was well-tolerated in infected individuals at the doses used," Treanoradded.
And -- along with data from the first Phase I study in 90patients -- that was enough to assure the company that thedrug is safe.
Shaman's next step is to seek regulatory approval to studywild-type RSV infection in children during the RSV season,which generally lasts from November through April. The dose-response portion of the upcoming trial, Conte told BioWorld,will be in hospitalized children under the age of two."Eventually, we'll be conducting Phase IIs on children on anoutpatient basis," she said.
-- Jennifer Van Brunt Senior Editor
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