Valortim designated OD by FDA

USA-based companies Medarex and PharmAthene say that their product Valortim (MDX-1303), designed to protect against inhalation anthrax, has been granted Orphan Drug Designation by the Food and Drug Administration. Preclinical assessment of the product suggested that it has the potential to provide significant protection against anthrax infection when administered as a prophylactic.

Valortim is a fully-human antibody, which is designed to target the protective antigen component of the toxin complex produced by Bacillus anthracis. The protective antigen is believed to both initiate the onset of illness and enable the entry of additional toxin into infected cells.

The product is currently being assessed in a Phase I open-label, dose-escalation clinical trial to evaluate its safety, tolerability, immunogenicity and pharmakokinetics, in healthy volunteers. The firms added that they expect the results later this year.