ATLANTA, April 9, 2008 /PRNewswire-USNewswire/ -- Dutch
biotechnology company Crucell N.V., the Aeras Global TB Vaccine
Foundation and the South African Tuberculosis Vaccine Initiative
(SATVI) present a progress update and immunology data from a
Phase I Ad35 tuberculosis vaccine study at the biennial
"Tuberculosis Vaccines for the World" conference (Atlanta,
Georgia, April 9 to 11) today. The study, conducted in Worcester,
South Africa and launched in May 2007, is the second phase I
study in a current series of three and has revealed promising
results.
Highest CD8 immune responses ever in a TB vaccine study
Preliminary data show both critical arms of the cellular immune
system, CD4 and CD8 immune T-cells were induced and that in those
participants who responded, CD8 immune responses are considerably
higher than has ever previously been seen in a TB vaccine study.
The trial of AERAS-402/Crucell Ad35, which began in May 2007, is
being conducted as a double-blind, randomized, placebo-controlled
dose escalation study in four groups of healthy adults vaccinated
at birth with BCG (Bacille Calmette-Guerin) vaccine. A total of
40 healthy adult volunteers are enrolled.
"While preliminary, these results are promising. We are pleased
that Crucell's technologies are playing a key role in the search
and development of a much-needed TB vaccine," said Dr. Jaap
Goudsmit, Chief Scientific Officer at Crucell. "We highly value
the collaboration with Aeras and SATVI on this important
mission."
Third key clinical phase I study in progress
Aeras and Crucell began jointly developing this vaccine candidate
in 2004 using Crucell's AdVac(R) vaccine technology and PER.C6(R)
manufacturing technology. A first Phase I clinical trial
launched in October 2006 in Kansas, USA indicated that the
vaccine candidate is safe in healthy adults in the US. The
results of a second study, launched in May 2007, are presented in
Atlanta at the "TB Vaccines for the World" conference. A third
phase I study in healthy adults in St. Louis, Missouri, USA was
launched in December 2007 and focuses on the immunogenicity and
safety of two AERAS-402/Crucell Ad35 boost doses administered at
three to six month intervals after BCG priming in healthy adults.
"The world urgently needs a new TB vaccine, and although we are
still in the early stages of clinical trials, the preliminary
data of this second phase I study are promising," said Dr. Jerald
C. Sadoff, President and CEO of Aeras. "Aeras is delighted to be
working with the excellent researchers at Crucell and SATVI. We
are grateful to the Bill & Melinda Gates Foundation, the
Netherlands Ministry of Foreign Affairs, and our other donors for
their financial support of this trial and our vaccine development
efforts."
This trial was conducted in the Boland-Overberg region of Western
Cape Province in South Africa, which has one of the world's
highest TB burdens.
"SATVI is proud to be playing such an important role in the
global effort to develop new vaccines to combat TB, which are
needed in South Africa and worldwide," said Dr. Gregory Hussey,
Director of SATVI and Principal Investigator for the trial. "By
conducting this trial, we have advanced the development of a new
TB vaccine, expanded scientific capacity, and built awareness of
the need for new TB vaccines."
About Tuberculosis
Tuberculosis is the world's second deadliest infectious disease,
with over 9 million new cases diagnosed in 2006. According to the
World Health Organization (WHO), an estimated 1.7 million people
died from TB in 2006. 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-Guerin (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 to 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(R) technology and Ad35
AdVac(R) 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(R) 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(R) technology is
based on adenoviruses that do not regularly occur 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(R) are produced using Crucell's
PER.C6(R) production technology.
About PER.C6(R) technology
Crucell's PER.C6(R) technology is a cell line developed for the
large-scale manufacture of biopharmaceutical products including
vaccines. The production scale potential of the PER.C6(R) 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(R)
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(R) 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 (http://www.aeras.org/) is
a non-profit organization working as a Product Development
Partnership to develop new tuberculosis vaccines and ensure that
they are distributed to all who need them around the world.
Aeras is funded by the Bill & Melinda Gates Foundation, the
Netherlands Ministry of Foreign Affairs, the Danish International
Development Agency, the Research Council of Norway and the U.S.
Centers for Disease Control and Prevention. Aeras, with over 110
employees, is based in Rockville, Maryland, where it operates a
state-of-the-art manufacturing and laboratory facility.
About Crucell
Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss: CRX.SW) is a
biotechnology company focused on research, development and
worldwide marketing of vaccines and antibodies that prevent and
treat infectious diseases. Its vaccines are sold in public and
private markets worldwide. Crucell's core portfolio includes a
vaccine against hepatitis B, a fully-liquid vaccine against five
important childhood diseases, and a virosome-adjuvanted vaccine
against influenza. Crucell also markets travel vaccines, such as
the only 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 Crucell
products based on its unique PER.C6(R) production technology. The
Company licenses this and other technologies to the
biopharmaceutical industry. Important partners and licensees
include DSM Biologics, sanofi aventis, GSK and Merck & Co.
Crucell is headquartered in Leiden (the Netherlands), with
subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the
US. The Company employs over a 1000 people. For more information,
please visit http://www.crucell.com/.
About SATVI
The South African Tuberculosis Vaccine Initiative is located in
the Institute of Infectious Disease and Molecular Medicine at the
University of Cape Town (UCT). Since 1999, with funding largely
from the Aeras Global TB Vaccine Foundation, SATVI has developed
the capacity to conduct registration standard vaccine trials at a
site in Worcester, some 110km outside Cape Town, where rates of
tuberculosis are amongst the highest in the world. SATVI has a
state of the art immunology laboratory located at UCT, where the
complex assays needed for TB vaccine studies can be performed. In
the last 6 years SATVI has conducted a number of very large field
trials and epidemiological cohort studies of the type which will
be necessary to test the efficacy of new tuberculosis vaccines,
involving thousands or tens of thousands of participants, as well
as a number of smaller phase one and two trials of new TB
vaccines. In addition, SATVI conducts cutting edge basic science
research aimed at better understanding the human immune response
to tuberculosis and to tuberculosis vaccines. For more
information, please visit http://www.satvi.uct.ac.za/.
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 U.S. Securities and
Exchange Commission on June 13, 2007, and the section entitled
"Risk Factors." The Company prepares its financial statements
under generally accepted accounting principles in the United
States (US GAAP) and Europe (IFRS).
CONTACT: Barbara Mulder, +1-31
Source: Aeras Global TB Vaccine Foundation
www.aegis.org