LEIDEN, THE NETHERLANDS--(Marketwire - April 14, 2010) - Dutch biopharmaceutical company
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL) (SWISS: CRX) and the Aeras
Global TB Vaccine Foundation today announced the start of a Phase II
trial of the jointly developed tuberculosis (TB) vaccine candidate
AERAS-402/Crucell Ad35 in HIV infected adults.
The Phase II study is designed to test the safety and efficacy of
AERAS-402/Crucell Ad35 in adults infected with HIV and will be conducted by
Aurum Institute in Klerksdorp, South Africa. All Aeras-sponsored TB vaccine
candidates have been or will be tested for safety in people living with
Among people living with HIV in Africa and Asia, TB is a leading cause of
People with HIV living in countries with high TB prevalence are 20 times
likely to develop TB than those who are HIV-negative. According to the
Health Organization's (WHO) 2009 TB surveillance report, one in four TB
globally is HIV-related, twice as many as previously recognized. In 2007,
were an estimated 1.4 million new cases of TB among people living with HIV
456 000 deaths. Seventy-one percent of people with TB in South Africa are
co-infected with HIV.
"With the support of Crucell's innovative technologies, we are on a joint
mission with Aeras to develop a next generation vaccine against TB," said
Jaap Goudsmit, Crucell's Chief Scientific Officer. "As there are many
uses of the new TB vaccine, it is crucial to test the safety and immune
responses in those who have been infected with HIV. That is why we are
pleased with the initiation of this Phase II study, an important next step
towards our ambition of reducing the global burden of this fatal disease."
Enrollment of study volunteers for the first stage of the Phase II trial
started. This is the first study testing the AERAS-402/Crucell Ad35 TB
candidate among this study population.
In 2004, Aeras and Crucell began jointly developing this vaccine candidate
Crucell's AdVac®vaccine technology and PER.C6® manufacturing
Data from all AERAS-402/Crucell Ad35 trials support the immunogenicity and
acceptable safety profile of the TB vaccine candidate at all dose levels
AERAS-402/Crucell Ad35 trials
In October 2008, the first Phase II study in adults who have had active TB
started in South Africa. In this ongoing study, AERAS-402 has demonstrated
acceptable safety profile. Preliminary data indicate that the candidate
induces CD8-cell immune responses in patients who have completed TB
To date, seven Phase I studies have been conducted in populations including
healthy adults and infants and adult tuberculosis patients:
* A trial in healthy adults not previously immunized with Bacille
Calmette-Guérin (BCG), the traditional TB vaccine, demonstrated that the
candidate vaccine had an acceptable safety profile in this population.
* A South African study showed CD8 T cell immune responses that are much
higher than those seen in humans in any previous TB vaccine study.
* US studies in healthy adults, focusing on the immunogenicity and safety
two boost doses after BCG priming, showed that two injections of the
candidate vaccine are immunogenic, with an acceptable safety profile, when
used in combination with a BCG prime, regardless of the boosting interval.
This immune response is greater than that detected in the absence of BCG
prime, supporting the possible utility of AERAS-402/Crucell Ad35 as a
booster vaccine. BCG prime alone shows limited efficacy.
* Testing of the candidate vaccine's safety in BCG-vaccinated adults with
without latent TB has been completed in Kenya, with ongoing analysis. The
vaccine had an acceptable safety profile in this study.
* A trial in South Africa is testing the safety of the candidate vaccine
infants previously vaccinated with BCG vaccine. The study is fully
and dosing is ongoing. To date, the vaccine appears to have an acceptable
safety profile in this study.
* Currently a US trial has started for more detailed analysis of the
response to AERAS-402/Crucell Ad35, using a known immunogenic regimen of
and the candidate vaccine in healthy adults, followed by collection of
numbers of immune cells.
Tuberculosis is the world's second deadliest infectious disease, with
9.3 million new cases diagnosed in 2007. According to the WHO, an estimated
million people died from TB in 2007. One-third of the world's population
been infected with the TB bacillus and current treatment takes 6-9 months.
current TB vaccine, Bacille Calmette-Guérin (BCG), developed over 85 years
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
with the highest rates of TB disease. TB is changing and evolving, making
vaccines more crucial for controlling the pandemic. Tuberculosis is now the
leading cause of death for people living with HIV/AIDS, particularly in
Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB)
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
reemerging infectious diseases, and in biodefense. The technology supports
practice of inserting genetic material from the disease-causing virus or
parasite into a 'vehicle' called a vector, which then delivers the
material directly to the immune system. Most vectors are based on an
such as the virus that causes the common cold. The AdVac® technology is
specifically designed to manage the problem of preexisting immunity in
against the most commonly used recombinant vaccine vector, adenovirus
5 (Ad5), without compromising large-scale production capabilities or the
immunogenic properties of Ad5. AdVac® technology is based on adenoviruses
do not regularly occur in the human population, such as Ad35. In contrast
instance Ad35 antibodies, antibodies to Ad5 are widespread among people of
ages and are known to lower the immune response to Ad5-based vaccines,
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
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®
lie in its excellent safety profile, scalability and productivity under
serum-free culture conditions. These characteristics, combined with its
to support the growth of both human and animal viruses, make PER.C6®
technology the biopharmaceutical production technology of choice for
current and potential pharmaceutical and biotechnology partners.
The Aeras Global TB Vaccine Foundation is a non-profit product development
partnership dedicated to the development of effective TB vaccine regimens
will prevent tuberculosis in all age groups and will be affordable,
and adopted worldwide. Aeras partners with academic, biotechnology,
pharmaceutical research institutes throughout the world to ensure rapid
development and ample vaccine distribution to eliminate TB. Aeras receives
funding from foundations and government aid agencies and has six TB vaccine
candidates in its product development pipeline. It operates from its
headquarters in Rockville, Maryland, and an office in Cape Town, South
For more information, please visit www.aeras.org.
About Aurum Institute
Aurum is an internationally recognized, specialist research and health
management organization. The focus is TB and HIV prevention, treatment and
The negative impact of the poor understanding and management of these
is vast, affecting individuals, communities and economies. The recognition
the huge advantages of controlling these diseases is Aurum's motivation.
has an international reputation for its work in the fields of tuberculosis,
HIV/AIDS and is the recipient of research and other grants from South
and international agencies and institutions for this work. For more
please visit www.auruminstitute.org.
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. Its vaccines are sold in public and private markets
worldwide. Crucell's core portfolio includes a vaccine against hepatitis B,
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
and the only aluminum-free hepatitis A vaccine on the market. The Company
broad development pipeline, with several product candidates based on its
PER.C6® production technology. The Company licenses its PER.C6®
and other technologies to the biopharmaceutical industry. Important
licensees include Johnson & Johnson, DSM Biologics, sanofi-aventis,
Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the
Netherlands, with subsidiaries in Argentina, China, Italy, Korea, Spain,
Switzerland, UK and the USA. The Company employs over 1200 people. For more
information, please visit www.crucell.com.
This press release contains forward-looking statements that involve
risks and uncertainties. We have identified certain important factors that
cause actual results to differ materially from those contained in such
forward-looking statements. For information relating to these factors
refer to our Form 20-F, as filed with the US Securities and Exchange
on April 7, 2010, in the section entitled 'Risk Factors'. The Company
its financial statements under International Financial Reporting Standards
For further information please contact Crucell:
Vice President Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
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