Shigamabs™ Preclinical Data
Preclinical studies of Shigamabs® have shown the antibodies to be safe, highly active and without any cross-reactivity to human tissues. The antibodies' half-lives or elimination times in vivo were similar to other monoclonal antibodies that have received regulatory approval.
Independent trials conducted by two different contract research organizations in mice and non-human primates examined the two antibodies separately and together at doses up to 30 mg/kg each without any observation of toxicity or maximum tolerated dose. The trials each concluded that there are no clinical, biological or histo-pathological signs of toxicity related to the administration of Shigamabs® at 10 times the planned clinical dose.
In recognized animal models of STEC, each antibody has independently demonstrated a protective effect at low doses, and animal rescue was demonstrated possible even when administration of cαStx2 was initiated up to 72 hours post-infection.
Demonstrated preclinical efficacy
Demonstrated therapeupic window
