The US FDA has granted Fast Track designation to Shigamabs, Caprion Pharmaceuticals dual antibody product being developed for the treatment of Shigatoxin-producing bacterial infections. The company anticipates moving Shigamabs into a pivotal phase II/III trial by the first quarter of 2007.

According to FDA, Hemolytic uremic syndrome (HUS) is a serious condition that may result from infection with Shigatoxin-producing bacteria. There are currently no therapies available for the prevention of HUS in infected patients, and therefore, the Shigamabs antibodies to Shigatoxins 1 and 2 have the theoretical potential to address this unmet medical need.

Dr. Marc Riviere, Caprion's executive VP of clinical development said, "Based on our clinical results to date, we believe that Shigamabs is a well-positioned candidate to become the first therapy for this significant unmet medical need."

Shigamabs is a single, intravenously administered product that consists of two monoclonal antibodies: caStx1 and caStx2. Shigamabs is being developed for the treatment of Shigatoxin-producing bacterial infections, the most common of which is caused by Shigatoxin-producing E. coli (STEC).

CellCarta, Caprion's proprietary proteomics technology, provides Caprion with an effective means to identify novel drug targets, predict which therapeutics may be safer and more efficacious and, in certain cases, identify which patients may benefit most from a particular therapy.