Medarex, Inc. (Nasdaq: MEDX) and PharmAthene, Inc. have recently announced the positive results of their Phase I study for Valortim™ (MDX-1303) in healthy volunteers.
Valortim™, a fully human antibody against anthrax infection has been developed using Medarex's UltiMAb Human Antibody Development System®.
The said Phase I clinical study was conducted to assess the safety and tolerability of Valortim in forty-six healthy volunteers that received either a single intravenous (IV) dose of Valortim ranging from 0.3 to 20.0 mg/kg (10 subjects in cohorts receiving 1.0, 3.0 or 10.0 mg/kg and 3 subjects in cohorts receiving 0.3 and 20 mg/kg) or a single 100 mg intramuscular (IM) dose of Valortim (10 subjects).
Results data showed that Valortim was safe and well tolerated while no drug-related Grade 2-4 or serious adverse events were reported.
These study results were presented in an oral presentation on Sunday, October 15, 2006, at the Infectious Diseases Society of America (IDSA) annual meeting held in
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