Crucell and NIH VRC Announce Start of Ebola Vaccine Clinical Trial
Leiden, The Netherlands, September 26, 2006 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced that the Ebola vaccine it is developing in partnership with the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has commenced its Phase I clinical 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 (IND) application process required by the Food and Drug Administration (FDA) in the US. 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 by the VRC at the NIH Clinical Center in Bethesda, Maryland. The main factors under examination are the vaccine's safety, tolerability and immunogenicity.
"We are proud that another of our vaccines is progressing to the clinic, and the Ebola vaccine is the first employing our adenovirus vaccine technology to do so," said Jaap Goudsmit, Chief Scientific Officer at Crucell. "Crucell and the VRC have so far made significant progress together, and we now aim to take our partnership to the next level in developing a vaccine against this extremely dangerous disease."
About Ebola
The Ebola virus is one of the few viruses capable of causing hemorrhagic fever, a severe, often-fatal disease in humans characterised by high fever and massive internal bleeding. Among other hemorrhagic fevers including Marburg and Lassa, Ebola causes death in 50% to 80% of all cases. Ebola outbreaks occur regularly in tropical Africa, affecting both human and great ape populations. Since the Ebola virus was first recognized, approximately 2,000 cases with over 1,200 deaths have been reported. Ebola usually appears in sporadic outbreaks, and spreads within a health-care setting. Because of the high disease-related mortality rates and lack of any vaccine or therapy, the Ebola virus is on the US Centers for Disease Control and Prevention (CDC) category "A" list of bioterror agents, together with smallpox and anthrax.
About Crucell-VRC Partnership
Crucell has entered into a Cooperative Research and Development Agreement (CRADA) with the VRC (www.vrc.nih.gov) 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 August 2002, the CRADA was extended to cover vaccines against Marburg and Lassa infections. In March 2005, Crucell secured an exclusive license to certain patents of the NIH for the development and commercialization of recombinant vaccines against Ebola, and a US$ 21.4 million manufacturing contract was signed with the NIH in April 2005, under which Crucell will manufacture its recombinant adenovirus vector Ebola vaccine for clinical trials in humans.