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PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop
Date:9/24/2008

onal anthrax on or before the fifth day post-exposure. Extended time-to-death (days 6-9) was observed in 5 of the 8 Valortim(R)-treated animals that succumbed to inhalational anthrax.

An oral presentation entitled, "Valortim(R), an Anti-toxin Monoclonal Antibody, for the Treatment and Post-exposure Prophylaxis of Inhalation Anthrax," provided a summary of the Valortim(R) development program.

In the Phase I clinical study, 46 human volunteers were administered either a single dose of intravenous (IV) Valortim(R) (dose range 0.3 mg/kg-20 mg/kg) or intramuscular Valortim(R) (100mg). Valortim(R) was found to be safe and well-tolerated with no drug-related Grade 2-4 or serious adverse events reported. PK analysis demonstrated a half-life of approximately 26 days for IV administration.

Valortim(R) has been tested in both the New Zealand White (NZW) rabbit and non human primate models to evaluate its efficacy in the post-exposure prophylaxis and therapeutic settings.

In the post-exposure setting, Valortim(R) was dosed starting one hour after spore exposure. Valortim(R) protected >85% of both NZW rabbits and non human primates at doses as low as 1 mg/kg beginning one hour after exposure to spores.

In the therapeutic setting, Valortim(R) was dosed starting at fixed time points after spore exposure (24 or 48 hours in the NZW rabbit) or after first demonstrating antigenemia by a positive ECL assay (AGM). Valortim(R) protected 88% and 42% of NZW rabbits that initiated treatment at 24 and 48 hours after spore exposure, respectively. When AGMs were treated with Valortim(R) at the time of first positive ECL after spore exposure, 56% of the animals survived.

"We are very excited about the animal model data from the AGM study, which showed over 50% of Valortim(R)-treated animals survived inhalational anthrax as compared to no controls. This is especially compelling given that the toxin-releasing bacteria were present in the bloodstream at th
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SOURCE PharmAthene, Inc.
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