FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13s - 16 or 15d - 16 of
the Securities Exchange Act of 1934
For the month of February 2006
Acambis plc
(Translation of registrant's name into English)
Peterhouse Technology Park
100 Fulbourn Road
Cambridge CB1 9PT
England
(address of principal executive offices)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F
Forms 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information
contained in this Form also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934).
Yes No X
(if "Yes" is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g3-2(b): 82- ).
Enclosure:
Research Update
Acambis announces results from Phase 1 trial of C. difficile vaccine
Cambridge, UK and Cambridge, Massachusetts -15 February 2006 - Acambis plc
(Acambis) (LSE: ACM, NASDAQ: ACAM) announces results from a Phase 1 trial of its
investigational vaccine against Clostridium difficile (C. difficile) in healthy
adults.
C. difficile infection is the leading cause of antibiotic-associated diarrhoea
in hospitals. Most C. difficile-associated disease (CDAD) cases involve elderly
individuals who become infected in hospitals and long-term care facilities that
have become reservoirs of these bacteria.
It is estimated that C. difficile causes at least 350,000 cases in the US alone
with annual costs to the healthcare system exceeding $1 billion.(1) Recently,
researchers from Canada, the UK and the US have reported markedly increased
rates of CDAD and more serious disease. In a recent outbreak in Quebec caused by
a new epidemic strain, the mortality attributable to C. difficile was 16.7%.(2)
Acambis' Phase 1 trial evaluated the safety, tolerability and immunogenicity of
its C. difficile vaccine when administered at different dose levels. The
randomised, double-blind, placebo-controlled study included a total of 50
healthy adult subjects: 37 subjects received Acambis' C. difficile vaccine and a
control group of 13 subjects received placebo.
Antibody responses were seen in all subjects who received Acambis' vaccine. Four
weeks after the first injection of the highest dose, anti-toxin A and anti-toxin
B immunoglobulin G levels were at least 10-fold higher than those reported in
another study of patients who had recovered from natural infection with C.
difficile and did not suffer recurrent disease.(3) Future efficacy trials will
investigate the antibody levels produced by the vaccine that are needed for
clinical protection against CDAD.
Vaccination at all dose levels was well tolerated in all subjects. The majority
of side effects observed were those typical of vaccines injected
intramuscularly. These reactions included mild tenderness, redness and pain at
the injection site, and headache. No subjects experienced unexpected or serious
vaccine-related adverse events.
Dr Thomas Monath, Chief Scientific Officer of Acambis, commented:
"The need for a vaccine to protect against C. difficile infection has grown with
the emergence of a hypertoxic and epidemic C. difficile strain associated with
severe disease, which has been reported in North America and the UK. These
results are encouraging and show that subjects vaccinated with our C. difficile
vaccine developed high levels of antibodies against toxins A and B, the toxins
responsible for CDAD."
Today, no vaccine exists to protect individuals against CDAD and Acambis is the
only company known to be developing a vaccine against it. Current treatment of
CDAD includes the use of an antibiotic, metronidazole or vancomycin, to
eradicate the C. difficile bacterium. Approximately 20% of treated patients
experience a relapse of CDAD.
As previously announced, a second Phase 1 trial of Acambis' C. difficile vaccine
is underway in healthy elderly adults with results expected later this year.
Phase 2 proof-of-principle trials are scheduled to commence before the end of
the year.
Enquiries:
Acambis:
Gordon Cameron, Chief Executive Officer
David Lawrence, Chief Financial Officer
Lyndsay Wright, VP, Communications and Investor Relations
Tel: +44 (0) 1223 275 300
Financial Dynamics:
David Yates/Davina Langdale
Tel: +44 (0) 20 7831 3113
About Acambis
Acambis is a leading developer of vaccines to prevent and treat infectious
diseases. Recognised internationally as the leading producer of smallpox
vaccines, Acambis is developing an investigational smallpox vaccine, ACAM2000,
and is manufacturing emergency-use stockpiles of this investigational vaccine
for the US Government and other governments around the world. It is also
developing an attenuated smallpox vaccine, MVA3000, under contracts with the US
National Institutes of Health. Acambis' US-based subsidiary Berna Products
Corporation markets Vivotif(R), the world's only licensed oral typhoid vaccine,
in North America. Acambis' investigational vaccine against Japanese
encephalitis, ChimeriVax-JE, is undergoing Phase 3 clinical testing. It also has
the most advanced investigational vaccine against the West Nile virus, which has
spread to 48 US States in the last six years, and a vaccine against Clostridium
difficile bacteria, a leading cause of hospital-acquired infections.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US. Its primary
listing is on the London Stock Exchange (ACM) and its shares are listed in the
form of American Depositary Receipts on NASDAQ (ACAM). More information is
available at www.acambis.com.
"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, product development, manufacturing 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 management" in
the Company's 2004 Annual Report and Form 20-F for the year ended 31 December
2004, in addition to those detailed on the Company's website and 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.
- --------------------------
(1) Kyne et al., Clinical Infectious Diseases 2002; 34:346-353
(2) Pepin et al., Canadian Medical Association Journal 2005; 173:1037-1042
(3) Kyne et al., New England Journal of Medicine 2000; 342:390-397
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant Peptide Therapeutics Group has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
Date: 15 February 2006 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.