Thallion Announces First Patient Enrolled In High Dose Cohort of Phase II SHIGATEC Trial
Product News May 31, 2011
Thallion Pharmaceuticals Inc. and LFB Biotechnologies have announced the enrollment of the first patient in the high dose cohort of the Company's Phase II SHIGATEC trial.
The high dose cohort (3 mg/kg/dose) is expected to enroll 21 patients which will complete the Phase II trial evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection. The Company anticipates top line results to be available prior to the end of the year.
"Following the positive recommendation from the IDMC after the low dose cohort and the resumption of patient enrollment in our SHIGATEC trial, we continue to push forward with the clinical development of our novel Shigamabs® treatment. Shigamabs® represents the most advanced clinical treatment in development for the prevention of a condition in which the current standard of care is simply to hydrate, wait and then monitor disease progression," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc.
"We believe a clear medical need exists for the treatment of STEC infections, and the recent German outbreak, where approximately 300 cases of haemolytic uraemic syndrome (HUS) and 10 deaths have been reported, is an unfortunate reminder of that," said Guillaume Bologna executive Vice-President for Development Programs of LFB Biotechnologies.