Jun 5, 2008 - Emergent BioSolutions Inc. (NYSE:EBS) announced today that dosing of patients has begun in a U.S. Phase II clinical trial of the company's single-dose oral typhoid vaccine candidate. This randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial is being conducted in healthy adults. The company anticipates that trial results will be available by year end. This US study will evaluate vaccine manufactured at the large-scale facility planned for commercial launch. This trial is designed to confirm the safety and immunogenicity of the vaccine, and Phase III trials are expected to begin in 2009. If approved, this candidate would be the first single-dose, drinkable typhoid vaccine available for adults and children.
"The commencement of this U.S. Phase II study represents an important milestone in the clinical development of our oral typhoid vaccine candidate," said Daniel Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "In previous clinical studies, this vaccine candidate has demonstrated promising immunogenicity and safety results in both children and adults. We are pleased with our continued progress in the development of this important vaccine candidate, which is a cornerstone in our company's mission of protecting life."
The whole story can be read here.
No comments:
Post a Comment