Crucell and NIH Announce Start of Malaria Vaccine Trial in Burkina Faso
(Thomson Reuters ONE) -
Leiden, the Netherlands (May 11, 2010) - Dutch biopharmaceutical company Crucell
N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced the
start of a Phase I clinical study in Burkina Faso of its AdVac(®)-based malaria
vaccine vector. Crucell is developing its malaria vaccine vector in
collaboration with the National Institute of Allergy and Infectious Diseases
(NIAID), part of the US National Institutes of Health (NIH), the Centre National
de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, and the
Noguchi Memorial Institute for Medical Research at the University of Ghana.
The study is a randomized, controlled, double-blinded, dosage-escalation
clinical trial evaluating the immunogenicity and safety of the recombinant
malaria vaccine vector Ad35-CS in malaria semi-immune, healthy adult volunteers
living in Burkina Faso. This is the first study evaluating the safety and
immunogenicity of this AdVac(®)-based malaria vaccine vector candidate in a
population residing in a malaria endemic area.
"We are very pleased that the collaboration with NIH enables us to enter into
this new trial," said Dr. Jerald Sadoff, Crucell's Chief Medical Officer at
Crucell. "Using Crucell's technologies, we are on a joint mission to develop a
vaccine against malaria, one of the top three killers in the world, causing
close to a million deaths every year, mostly amongst children."
The study is funded by NIAID/NIH and conducted by Burkinabè researchers at the
CNRFP, lead by the director of the CNRFP Dr. Sodiomon B. Sirima, MD, PhD. "The
innovative approach in designing this malaria vaccine vector gives us confidence
that it could open a new, promising era in the quest for an effective malaria
vaccine, which would save the lives of millions of our children." said Dr.
Sirima.
A Phase I clinical study recently completed in the United States demonstrated
that the Ad35-CS vector has an acceptable safety and immunogenicity profile in
malaria naïve, healthy adult volunteers.
About AdVac(®) technology
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 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
preexisting 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 do not regularly occur in the human
population, such as Ad26 and Ad35. In contrast to Ad26 and 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 Crucell's malaria vaccine
Crucell is developing a recombinant malaria vaccine, Ad35-CS, based on the
company's AdVac(®) technology and PER.C6(®) manufacturing platform. The vaccine
candidate is made by inserting the gene for the CSP from the P. falciparum
malaria parasite into adenoviral vectors, which act as a 'vehicle' for
vaccination delivery. This prime vaccine candidate is currently being tested in
a phase I study in partnership with the National Institute of Allergy and
Infectious Diseases (NIAID).
About Crucell
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: 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 fast
majority of doses 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(®).
Quinvaxem(®) protects against five important childhood diseases and over 130
million doses have been sold since its launch in 2006 in more than 50 GAVI
countries. Through Quinvaxem(®) and its innovation, Crucell has become a major
partner in protecting children in developing countries. Crucell's core portfolio
also includes 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
subsidiaries in Argentina, China, Italy, Korea, Spain, Sweden, Switzerland, UK
and the USA. The Company employs over 1200 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:
Oya Yavuz
Vice President Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
www.crucell.com
[HUG#1414437]
PDF file: http://hugin.info/132631/R/1414437/365734.pdf
Unternehmensinformation / Kurzprofil:
Datum: 11.05.2010 - 07:45 Uhr
Sprache: Deutsch
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