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news.Canadian drug developer Thallion Pharmaceuticals has terminated the screening procedure and patient recruitment of high dose cohort in the randomized, double-blind, placebo-controlled SHIGATEC Phase II study temporarily.
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The first cohort of the SHIGATEC trial compares standard of care combined with a low dose of Shigamabs (1 mg/kg/dose) versus standard of care with placebo, in patients aged six months to 18 years who have tested positive for STEC infection (foodborne bacterial infection).
The second cohort will compare standard of care combined with a high dose of Shigamabs (3 mg/kg/dose) versus standard of care with placebo.
Thallion has observed out-of-specification (OOS) finding during routine stability testing of anti-Stx1 monoclonal antibody.
Thallion and its partner LFB Biotechnologies are analysing the nature of the product and will intimate the steps to be taken soon.
Thallion CEO Allan Mandelzys said until they have more complete data to fully assess the situation, they determined that temporarily suspending enrollment is the appropriate and most conservative decision.