Molecular Templates Announces Partial Clinical Hold for Phase 1 Study of MT-0169
Partial hold based on previously disclosed cardiac events at 50 mcg/kg cohort; FDA to review safety data in lower dose cohorts
AUSTIN, Texas, April 07, 2023 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), today announced that the U.S. Food and Drug Administration (the “FDA”) informed MTEM that it has placed a partial clinical hold on the Phase 1 study of MT-0169 based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg that prompted the dose reduction to 5 mcg/kg last year. Since then, four patients have been dosed at 5 mcg/kg and three patients have been dosed at 10 mcg/kg with no cardiac adverse events noted.
Of the patients dosed at 50 mcg/kg, one patient experienced asymptomatic grade 2 myocarditis and one patient experienced asymptomatic grade...
