CRUCELL, NIH INITIATE TRIAL OF EBOLA VACCINE

Crucell has announced that the Ebola vaccine it is developing in partnership with the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has begun a Phase I study. The randomized, double-blind, placebo-controlled study in 48 healthy volunteers will test the single-shot vaccination in a dose-escalation trial.

The start of the trial follows the successful completion of the investigational new drug application process required by the FDA. In preclinical studies, a single shot of the PER.C6-based vaccine protected monkeys completely against a lethal Ebola challenge. The Phase I study will be carried out at the NIH Clinical Center in Bethesda, Md. The main factors under examination are the vaccine's safety, tolerability and immunogenicity.

Crucell has entered into an agreement with the NIH to jointly develop, test and manufacture an adenovirus-based Ebola vaccine. Under the terms of the agreement, Crucell has an option for exclusive worldwide commercialization rights to the Ebola vaccine resulting from this collaboration. In 2002 the agreement was extended to cover vaccines against Marburg and Lassa infections. In 2005 Crucell secured an exclusive license to certain patents of the NIH for the development and commercialization of recombinant vaccines against Ebola and a $21.4 million manufacturing contract.