Crucell and Harvard (BIDMC) Join Forces with IAVI to Advance AdVac®-based AIDS Vaccine
(Thomson Reuters ONE) -
Leiden, the Netherlands (August 11, 2010) - Dutch biopharmaceutical company
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announces
its intention to participate in an international Phase I clinical trial in the
United States and Africa of a combination of two AdVac(®)-based AIDS vaccine
candidates, Ad26.ENVA.01 and Ad35-ENV, in healthy adults who are not infected
with HIV. The clinical trial, which will be led by the International AIDS
Vaccine Initiative (IAVI), represents a collaboration between IAVI, Crucell, the
Ragon Institute, and Beth Israel Deaconess Medical Center (BIDMC), a major
teaching hospital of Harvard Medical School.
The Ad26.ENVA.01 vaccine candidate used in this study is manufactured by
Crucell, while the Ad35-ENV vaccine is developed by IAVI. Both vaccines
candidates are based on Crucell's proprietary AdVac(®) technology. The planned
Phase 1 trial of the vaccine combination, which follows a Phase I trial of the
Ad35-ENV vaccine by IAVI and a Phase I trial of Ad26.ENVA.01 by the
Harvard-Crucell consortium, supported by the National Institute of Allergy and
Infectious Diseases (NIAID), represents a key step towards proof of concept
studies to evaluate the efficacy of the vaccine combination in humans.
The Phase I trial is designed to test two AIDS vaccine candidates in a
prime-boost combination in HIV-uninfected healthy adult volunteers. The
objectives are to evaluate the safety of the candidate vaccines Ad26.ENVA.01 and
Ad35-ENV and their ability to provoke an immune response when administered in a
prime-boost regimen.
"We are very happy that IAVI has decided to support the NIAID-sponsored
Crucell-Harvard AIDS vaccine program, making it possible to advance this vaccine
candidate further towards proof of concept Phase IIb efficacy trials in humans,"
said Jaap Goudsmit, Chief Scientific Officer at Crucell. "A different
prime-boost AIDS vaccine approach has been shown in the RV144 trial (Thai Trial)
to protect against HIV in humans, for the first time in the history of AIDS
vaccine development. Our program to develop this combination vaccine represents
one of the most advanced AIDS vaccine programs in the world and is based on the
best science available today. We have the obligation as vaccine producers to do
everything in our power to bring an effective AIDS vaccine to all people in
need."
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 (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 1200
people. For more information, please visit www.crucell.com.
About Crucell's AdVac(®) technology
AdVac(®) technology is a vaccine technology developed by Crucell. It 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 Ad26 and 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 the Crucell-Harvard (BIDMC) AIDS/HIV Vaccine (Phase I)
In April 2008, Crucell announced the start of a Phase I clinical study of the
novel recombinant HIV vaccine. The vaccine is based on Crucell's AdVac(®) and
PER.C6(®) technologies, using adenovirus serotype 26 (rAd26) as vector, and is
jointly developed by Crucell and the BIDMC, funded by a grant from the US
National Institute of Allergy and Infectious Diseases, part of the National
Institutes of Health. The rAd26 vector is designed to avoid pre-existing
neutralizing antibodies to the more commonly used adenovirus serotype 5 (Ad5).
Phase I clinical studies are being conducted at the Brigham and Women's Hospital
in Boston, USA and are focused on assessing the safety and immunogenicity of the
vaccine in several trials including single and multi-dose regimens. In October
2009, preliminary results of the Phase I study were presented at La Conférence
AIDS Vaccine 2009 in Paris, France. The presentation was given by Dr Dan H.
Barouch, MD, PhD, Associate Professor of Medicine, Division of Vaccine Research,
Department of Medicine, BIDMC, Boston, USA. The preliminary results of this
study show that a 3-dose regimen of this HIV candidate vaccine is safe and
immunogenic.
About the International AIDS Vaccine Initiative (IAVI)
IAVI's core mission is to support in every way the development of preventive
AIDS vaccines that are not only safe and effective, but also accessible to all
people. To that end, IAVI invests the bulk of its resources in the research and
clinical assessment of candidate vaccines against strains of HIV that are
prevalent in the developing world, where some 95% of new HIV infections occur.
For more information, visitwww.iavi.org.
About Beth Israel Deaconess Medical Center (BIDMC)
BIDMC is a patient care, teaching and research affiliate of Harvard Medical
School, and consistently ranks in the top four in National Institutes of Health
funding among independent hospitals nationwide. BIDMC is clinically affiliated
with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard
Cancer Care Center. For more information, visitwww.bidmc.org.
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
ir(at)crucell.com
www.crucell.com
[HUG#1436935]
PDF file:
http://hugin.info/132631/R/1436935/381817.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
All reproduction for further distribution is prohibited.
Source: Crucell N.V. via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 11.08.2010 - 07:45 Uhr
Sprache: Deutsch
News-ID 39328
Anzahl Zeichen: 0
contact information:
Town:
Leiden
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 183 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Crucell and Harvard (BIDMC) Join Forces with IAVI to Advance AdVac®-based AIDS Vaccine"
steht unter der journalistisch-redaktionellen Verantwortung von
Crucell N.V. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
