Caprion Pharmaceuticals Inc. has announced the completion of Phase I studies for Shigamabs, its therapeutic product currently in human clinical trials for the treatment of Shigatoxin-producing E. coli infections.
Infections by Shigatoxin-producing E. coli (STEC), including the O157:H7 strain involved in the current US outbreak, cause severe clinical symptoms such as hemorrhagic colitis, thrombocytopenia, hemolytic anemia and hemolytic uremic syndrome in up to 60 per cent of all infected patients, and are potentially lethal in the most severe cases. Serious complications are most frequent in young children and the elderly. There are no treatments currently available for STEC infections.
The safety and tolerability of Caprion's anti-toxin antibodies were evaluated in 40 healthy adult volunteers. Shigamabs were shown to be safe and well tolerated when given individually or concomitantly in 3 clinical studies conducted over the last 4 years at major medical centers in the US and Canada. Detailed results will be presented at the upcoming VTEC 2006 meeting in Melbourne, Australia.
Caprion anticipates moving Shigamabs into a European Union and North American pivotal trial in 2007 pending final regulatory review.
Caprion Pharmaceuticals Inc. is a clinical-stage biotechnology company developing pharmaceutical products in the areas of infectious disease and oncology. The company's clinical-stage programs include: Shigamabs, a product for the treatment of Shigatoxin-producing bacterial infections, and CAP-232, a peptide with broad applicability in several oncology indications. Additionally, 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.