CAMBRIDGE, England
and CAMBRIDGE, Mass., Nov. 25 /PRNewswire-FirstCall/ -- Acambis
plc ("Acambis") (Nasdaq:
ACAM -
News; LSE:
ACM -
News)
announces it has successfully completed a Phase I trial in its
development of a vaccine against the virus that causes dengue
fever.
This initial Phase I trial tested in 56 healthy adult
volunteers the safety, tolerability and immunogenicity of one of
the four components in Acambis' ChimeriVax-Dengue vaccine. The
component tested is known as ChimeriVax-DEN2 as it is targeted
against the Dengue 2 serotype.
The trial incorporated several elements:
-- a randomised, double-blind element in 42 volunteers compared the
safety and immunogenicity of ChimeriVax-DEN2 at two dose levels with a
licensed yellow fever vaccine, YF-VAX(R). All these volunteers had
not previously had contact with yellow fever; and
-- an open-label portion of the trial included 14 volunteers who had
previously received a yellow fever vaccine. They were vaccinated with
ChimeriVax-DEN2 to test whether prior immunity to yellow fever would
inhibit the response to ChimeriVax-DEN2. This is because the
ChimeriVax technology from which ChimeriVax-DEN2 was developed employs
an attenuated yellow fever virus as a backbone.
The preliminary findings from the trial are as follows:
-- ChimeriVax-DEN2 was well-tolerated at the two dose levels tested;
-- there were no serious adverse events;
-- 100% of subjects developed neutralising antibodies to the homologous
Dengue 2 serotype virus within one month of vaccination and
96% developed neutralising antibodies to a wild-type Dengue 2 virus;
-- the seroconversion rate was similar at both dose levels tested; and
-- prior immunity to yellow fever did not inhibit response to
ChimeriVax-DEN2.
There are four immunologically related dengue virus
serotypes, each of which needs to be represented in an effective
vaccine. Acambis has successfully constructed vaccines against
all four dengue virus serotypes and tested the immunogenicity,
safety and efficacy of the tetravalent (four- component) vaccine
in pre-clinical models. A Phase I trial of the tetravalent
vaccine, ChimeriVax-Dengue, is planned for the first half of
2003.
Dr John Brown, Chief Executive Officer of Acambis, said:
"Dengue fever is a major problem across the world, with an
estimated 50 million cases every year. Development of an
effective vaccine to prevent dengue fever is critical for the
two-fifths of the world's population who are at risk from
infection and these positive trial results represent a
significant step along the road to achieving that goal."
The ChimeriVax-Dengue project is funded by Acambis' partner,
Aventis Pasteur, who holds worldwide rights to sales of the
vaccine.
A spokesperson for Aventis Pasteur commented:
"From our Aventis Pasteur partnership perspective, these
results further illustrate the attractiveness of the ChimeriVax
technology for vaccine development. Aventis Pasteur is
encouraged to press ahead with trials of the tetravalent
ChimeriVax-Dengue."
Acambis
Acambis is a biopharmaceutical company discovering,
developing and manufacturing vaccines to prevent and treat
infectious diseases. It has operations in Cambridge, UK, and in
Cambridge, Massachusetts, US. It has a broad portfolio of
vaccine product candidates undergoing clinical trials and
technology platforms that provide the basis for further vaccine
product candidates.
Dengue fever
Found in most tropical and subtropical areas of the world,
dengue fever is a disease caused by infection with a virus
transmitted to humans by infected mosquitoes. According to the
World Health Organization ("WHO"), the global prevalence of
dengue has grown dramatically in recent decades and is now
endemic in more than 100 countries in Africa, the Americas, the
eastern Mediterranean, south-east Asia and the western Pacific.
This puts two-fifths of the world's population at risk from
dengue. The WHO estimates that there are approximately 50
million dengue infections each year and 500,000 cases of the
more severe form of the disease, dengue haemorrhagic fever.
"Safe Harbor" Statement Under the Private Securities
Litigation Reform Act
of 1995:
The statements in this news release that are not historical
facts are forward-looking statements that involve risks and
uncertainties, including the timing and results of clinical
trials and other product development and commercialisation
risks, the risks of satisfying the regulatory approval process
in a timely manner, the need for and the availability of
additional capital. For a discussion of these and other risks
and uncertainties see "Risk factors" in the Company's Annual
Report and Form 20-F for the most recently ended fiscal year, in
addition to those detailed in the Company's filings made with
the Securities and Exchange Commission from time to time. These
forward-looking statements are based on estimates and
assumptions made by the management of Acambis and are believed
to be reasonable, though are inherently uncertain and difficult
to predict. Actual results or experience could differ materially
from the forward-looking statements.
This, and other news releases relating to Acambis, can be
found on the Company's website at
http://www.acambis.com .