LEIDEN, NETHERLANDS--(Marketwire - September 22, 2010) -
Study to Test New Tuberculosis Vaccine in Infants
Leiden, The Netherlands / Rockville, MD, USA (September 22, 2010) -
Dutch
biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL) (SWISS: 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-Guérin (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 courses 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."
fAERAS-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.
About Tuberculosis
Tuberculosis is the world's second deadliest infectious disease, with
nearly
9.3 million new cases diagnosed in 2007. According to the World
Health
Organization (WHO), an estimated 1.8 million people died from TB in
2007.
One-third of the world's population has been infected with the TB
bacillus and
current treatment takes 6-9 months. The current TB
vaccine, Bacille
Calmette-Guérin (BCG), developed over 85 years ago, reduces the risk
of severe
forms of TB in early childhood but is not very effective in preventing
pulmonary
TB in adolescents and adults - the populations with the highest rates
of TB
disease. TB is changing and evolving, making new vaccines more
crucial for
controlling the pandemic. Tuberculosis is now the leading cause of
death for
people living with HIV/AIDS, particularly in Africa. Multidrug-
resistant TB
(MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering
treatment and
control efforts.
About AdVac® technology and Ad35
AdVac® technology is a vaccine technology developed by Crucell and is
considered
to play an important role in the fight against emerging and re-
emerging
infectious diseases, and in biodefense. The technology supports the
practice of
inserting genetic material from the disease-causing virus or parasite
into a
'vehicle' called a vector, which then delivers the immunogenic material
directly
to the immune system. Most vectors are based on an adenovirus, such
as the
virus that causes the common cold.
The AdVac® technology is specifically designed to manage the
problem of
pre-existing immunity in humans against the most commonly used
recombinant
vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-
scale
production capabilities or the immunogenic properties of Ad5. AdVac®
technology
is based on adenoviruses that occur less frequently in the human
population,
such as Ad35. In contrast to for instance Ad35 antibodies, antibodies to
Ad5 are
widespread among people of all ages and are known to lower the immune
response
to Ad5-based vaccines, thereby impairing the efficacy of these
vaccines. All
vaccine candidates based on AdVac® are produced using
Crucell's PER.C6®
production technology.
About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the
large-scale
manufacture of biopharmaceutical products including vaccines. The
production
scale potential of the PER.C6® cell line has been
demonstrated in an
unprecedented successful bioreactor run of 20,000 liters.
Compared to
conventional production technologies, the strengths of the PER.C6®
technology
lie in its excellent safety profile, scalability and productivity
under
serum-free culture conditions. These characteristics, combined with its
ability
to support the growth of both human and animal viruses, make
PER.C6®
technology the biopharmaceutical production technology of choice for
Crucell's
current and potential pharmaceutical and biotechnology partners.
About Aeras
The Aeras Global TB Vaccine Foundation (www.aeras.org) is a non-profit
research
organization developing new tuberculosis vaccines and ensuring that
they are
distributed to all who need them around the world. Aeras is funded
primarily by
private foundations and government aid agencies. Aeras is based in
Rockville,
Maryland, where it operates a state-of-the-art manufacturing and
laboratory
facility, and Cape Town, South Africa.
About KEMRI/CDC
The KEMRI/CDC Research and Public Health Collaboration in Kenya was
established
in 1979 by the Kenya Medical Research Institute (KEMRI) and the United
States
Centers for Disease Control and Prevention (CDC). KEMRI is a parastatal
in the
Kenyan Ministry of Health and is responsible for conducting research
into the
major public health problems of the country. Until 2000, KEMRI/CDC
focused
mostly on malaria research, but today HIV and TB research activities are
also
primary focuses. The KEMRI/CDC field site in Kisumu is one of few sites
in the
world capable of conducting large?scale late phase TB vaccine
trials. The
KEMRI/CDC Research and Public Health Collaboration has well-developed
malaria,
HIV, microbiology, and tuberculosis laboratories that perform a
range of
standard diagnostic procedures. KEMRI/CDC is well positioned to
play an
important role in global surveillance to monitor infectious diseases,
assess
problems of public health importance such as the spread of
antimicrobial
resistance, and provide a basis for evaluating interventions designed to
reduce
the burden of disease among vulnerable groups. For more information,
please
visitwww.kemri.org and www.cdc.gov.
About Crucell
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL) (SWISS: CRX) is a global
biopharmaceutical company focused on research development, production and
marketing of vaccines, proteins and antibodies that prevent and/or treat
infectious diseases. In 2009 alone, Crucell distributed more than 115
million
vaccine doses in more than 100 countries around the world, with the vast
majority of doses (97%) going to developing countries. Crucell is one of
the
major suppliers of vaccines to UNICEF and the developing world. Crucell was
the
first manufacturer to launch a fully-liquid pentavalent vaccine. Called
Quinvaxem®, this innovative combination vaccine protects against five
important childhood diseases. Over 130 million doses have been sold since
its
launch in 2006 in more than 50 GAVI countries. With this innovation,
Crucell has
become a major partner in protecting children in developing countries.
Other
products in Crucell's core portfolio include a vaccine against hepatitis B
and a
virosome-adjuvanted vaccine against influenza. Crucell also markets travel
vaccines, such as an oral anti-typhoid vaccine, an oral cholera vaccine and
the
only aluminum-free hepatitis A vaccine on the market. The Company has a
broad
development pipeline, with several product candidates based on its unique
PER.C6® production technology. The Company licenses its PER.C6®
technology and other technologies to the biopharmaceutical industry.
Important partners and
licensees include Johnson & Johnson, DSM Biologics, sanofi-aventis,
Novartis,
Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the
Netherlands, with offices in China, Indonesia, Italy, Korea, Malaysia,
Spain,
Sweden, Switzerland, UK, the USA and Vietnam. The Company employs over 1300
people. For more information, please visit www.crucell.com.
Forward-looking statements
This press release contains forward-looking statements that involve
inherent
risks and uncertainties. We have identified certain important factors that
may
cause actual results to differ materially from those contained in such
forward-looking statements. For information relating to these factors
please
refer to our Form 20-F, as filed with the US Securities and Exchange
Commission
on April 7, 2010, in the section entitled 'Risk Factors'. The Company
prepares
its financial statements under International Financial Reporting Standards
(IFRS).
For further information please contact:
Crucell N.V. Aeras Global TB Vaccine
Foundation
Oya Yavuz Annmarie Leadman
Vice President Corporate Communications & Director of Communications
Investor Relations Tel: +1 240 599 3018
Tel: +31 71 519 7064 aleadman@aeras.org
ir@crucell.com www.aeras.org
www.crucell.com
[HUG#1445824]
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