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 November 2005
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 starts Phase I trial of C. difficile vaccine in elderly subjects
Cambridge, UK and Cambridge, Massachusetts - 28 November 2005 - Acambis plc
("Acambis") (LSE: ACM, NASDAQ: ACAM) announces that it has started a Phase I
clinical trial of its investigational vaccine against Clostridium difficile (C.
difficile) in healthy elderly subjects. This follows an initial Phase I safety
and immunogenicity trial in healthy young adults that commenced in July and is
the next step in the Company's clinical development plan for this vaccine
candidate.
C. difficile infection, which is characterised by diarrhoea and colitis, is one
of the most common hospital-acquired infections around the world. A
hyper-virulent, hyper-toxigenic strain of C. difficile has recently emerged and
is believed to be responsible for sharp increases in the number of infections
and deaths associated with the infection in countries including the UK, Canada
and the US.(1)
The Phase I trial is designed to obtain information on the safety, tolerability
and immunogenicity of Acambis' C. difficile vaccine when administered at
different dose levels. The randomised, double-blind, placebo-controlled study in
healthy elderly subjects is being conducted in the US.
Acambis is the only company with a vaccine against C. difficile in clinical
development. Its vaccine is designed to provide protective immunity against
toxins A and B, the toxins responsible for the development of C.
difficile-associated disease (CDAD). The primary market for the vaccine is those
most at risk of CDAD, such as the elderly, individuals entering nursing homes
and chronic disease sufferers at risk of hospitalisation, and relapsers.
Dr Thomas Monath, Chief Scientific Officer of Acambis, commented:
"The emerging hyper-toxigenic C. difficile strain has become a growing problem
in hospitals around the world. We believe that a preventative vaccine could be a
particularly effective approach in the fight against CDAD and are pleased to be
progressing our vaccine candidate into clinical testing in one of the main
target populations."
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 is establishing a travel vaccines
franchise through its US-based subsidiary Berna Products Corporation, which
markets Vivotif(R), the world's only licensed oral typhoid vaccine, in North
America. Acambis has other potential travel vaccines in development and is also
developing an investigational vaccine against the West Nile virus, which has
spread to 48 US States in the last six years.
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) Warny, M, Pepin, J, et al. Toxin production by an emerging strain of
Clostridium difficile associated with outbreaks of severe disease in North
American and Europe. Lancet 2005; 366:1079-1084.
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:28 November 2005 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.