Thallion Pharmaceuticals Inc. has announced that the Independent Data Monitoring Committee (IDMC) for the Company's Phase II SHIGATEC trial has completed a planned safety analysis and recommends that the trial continue as per the protocol.
This scheduled review by the IDMC occurred after the treatment and 56-day follow-up of the 22 patients that received the low dose treatment (1 mg/kg/dose) in the first cohort of the trial.
The purpose of the IDMC is to provide objective, independent safety monitoring of the SHIGATEC trial, a study evaluating Shigamabs® as a treatment for Shiga toxin-producing E. coli (STEC) infection.
Thallion has advised its clinical sites to initiate enrollment of the second, high dose, cohort of the trial in which patients will receive 3 mg/kg/dose.
The Company anticipates the completion of patient enrollment and the top line results to be available prior to the end of the year.
"The IDMC's recommendation based on the Phase II data obtained to date is consistent with the strong safety profile observed during the four previous Phase I studies," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc.
"We can now proceed as planned to enroll the final 21 patients in this Phase II trial at our clinical sites in South America."
Thallion expects to present the blinded safety results from the first cohort at a scientific conference in the second half of 2011.