Thallion and LFB Initiate Phase II SHIGATEC Trial
News Nov 30, 2010
Thallion Pharmaceuticals Inc. and LFB Biotechnologies (LFB) have announced the initiation of a Phase II trial (SHIGATEC trial) in South America evaluating Shigamabs® as a treatment for Shigatoxin-producing E. coli (STEC) infections. The timing of the Phase II clinical trial coincides with the seasonal high period for STEC infections in the Southern hemisphere. The study will comprise up to 18 clinical sites in Argentina, Chile and Peru.
“Since signing the licensing agreement with LFB last February, our primary development goal was to get Shigamabs® back into the clinic before year end and maximize recruitment during the high incidence season in South America,” said Dr. Allan Mandelzys, Chief Executive Officer of Thallion Pharmaceuticals Inc.
“STEC infection is a completely unmet medical need that affects more than 300,000 people in the industrialized world annually. No approved therapies exist today, with the current standard of care being to hydrate and then wait for disease progression. Our novel, dualantibody approach has the potential to be the first treatment to address this patient population.”
The randomized, double-blind, placebo-controlled trial will enroll 42 patients aged six months to 18 years testing positive for STEC infection, distributed in two cohorts. The first cohort will compare standard of care combined with a low dose of Shigamabs® (1 mg/kg) versus standard of care with placebo, followed by an interim analysis of data for safety conducted by an Independent Data Monitoring Committee (IDMC).
Following a positive recommendation to proceed by the IDMC, the second cohort will compare standard of care combined with a high dose of Shigamabs® (3 mg/kg) versus standard of care with placebo. The primary endpoints for the Phase II trial are safety and tolerability. Secondary endpoints include pharmacokinetics and objective measures of efficacy using single and composite endpoints. Data from the core study is expected within 9-12 months, with long term safety data available after a one year follow-up period (extension phase).