Caprion Receives FDA Fast Track Designation for Shigamabs Clinical Program

16-May-2006

Caprion Pharmaceuticals Inc. announced that the US food and Drug Administration (FDA) has granted Fast Track designation to Shigamabs, its 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.

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). STEC is transmitted by contaminated food or water. In 50% of people that experience Shigatoxin-mediated events, clinical outcomes include hemolytic anemia, thrombocytopenia, kidney failure, brain damage, and for 2% to 3% of such patients, death. There is currently no approved treatment for STEC infections.

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous