Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Study to test new tuberculosis vaccine in infants

Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) and the Aeras Global TB Vaccine Foundation today announced the start of a Phase II clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35.

The main objective of the trial is to test the safety and efficacy of the TB vaccine candidate in infants previously vaccinated with the Bacille Calmette-Gu-rin (BCG) vaccine, which is currently the only vaccine licensed to help prevent TB. The first part of this clinical trial, which will be conducted in Kenya, will establish the optimal dosing regimen. The selected regimen will then be tested in the second part of the trial, which is planned to begin in 2011 in Kenya, Mozambique, South Africa and Uganda.

The Phase II study of AERAS-402/Crucell Ad35 is being led in Kenya by a joint research project of the Kenya Medical Research Institute and the US Centers for Disease Control and Prevention, called the KEMRI/CDC Research and Public Health Collaboration. Participants from the Siaya District in Nyanza Province of Western Kenya will be enrolled.

"Despite the availability of the BCG vaccine, two million men, women and children die from tuberculosis every year. We urgently need a new TB vaccine to ensure long-term and effective TB protection," said Jim Connolly, President and CEO of the Aeras Global TB Vaccine Foundation. "This clinical trial represents an important step in our collaboration among a global network of researchers and the people of Kenya, who continue to be at high-risk for TB infection."

In 2004, Aeras and Crucell began jointly developing this vaccine candidate using Crucell's AdVac- vaccine technology and PER.C6- manufacturing technology.

"I am extremely pleased at the pace in which our work to develop a next generation vaccine against TB is progressing. Our successful collaboration with Aeras, enabling the initiation of yet another Phase II study, is an important step towards our ambition of reducing the global burden of this fatal disease," said Jaap Goudsmit, Crucell's Chief Scientific Officer.

Kenya is ranked 13th on a list of 22 high-burden TB countries, according to the World Health Organization. In 2007, 24,000 Kenyans died from TB and there were 132,000 new cases.

"The communities in which we work are hard hit by both TB and HIV/AIDS, two leading causes of mortality," said Videlis Nduba, MD, MPH, Principal Investigator for the trial at KEMRI/CDC Research and Public Health Collaboration. "We are pleased to apply our research expertise at this stage in the development of this vaccine-a vaccine which has undergone considerable early-stage safety testing."

AERAS-402/Crucell Ad35 has been tested in seven early-stage clinical trials including a phase I clinical trial in infants in South Africa. A Phase II trial to test its safety and efficacy in adults living with HIV is ongoing in South Africa. To date, the candidate has been shown to have an acceptable safety profile in these populations.