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 August 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 announces results of ChimeriVax-JE bridging study; on track to commence
Phase lll trials in 2005
Cambridge, UK and Cambridge, Massachusetts - 23 August 2005 - Acambis plc
("Acambis") (LSE: ACM, NASDAQ: ACAM) today announces results of a "bridging"
trial of ChimeriVaxTM-JE, its investigational vaccine against Japanese
encephalitis. Successful completion of the trial ensures that Acambis is on
track to initiate pivotal Phase lll testing of the vaccine before the end of
2005.
A bridging study was undertaken following scale-up to commercial scale
manufacture of ChimeriVax-JE at Acambis' plant in Canton, MA. Results from the
trial demonstrate, on average, a 96% seroconversion to JE-neutralising
antibodies after a single dose of ChimeriVax-JE vaccine in all trial subjects,
which is consistent with the profile seen in the Phase l and ll trials
previously conducted. Results from the trial have also enabled Acambis to define
the vaccine dose level for Phase III clinical studies.
In addition to the bridging study, Acambis has been conducting supplementary
Phase ll trials to provide a comprehensive database to support its product
licence application. Data generated on duration of immunity 12 months after
vaccination has enabled Acambis to take a single-dose product to Phase lll
testing.
One additional Phase II study was recently completed, which was designed to
investigate the effect of administering ChimeriVax-JE in three different
regimens: before, after or at the same time as yellow fever 17D vaccine. This
study was conducted since the ChimeriVax technology uses an attenuated yellow
fever 17D backbone. No clinically significant interactions were observed and
high levels of neutralising antibodies to both JE and yellow fever were found in
all three treatment groups.
Gordon Cameron, Chief Executive Officer of Acambis, said:
"As a result of our strategy of investing in our pipeline to drive the
development of our products, we have seen significant progress in the
development of ChimeriVax-JE. In addition, by bringing manufacture of
ChimeriVax-JE in-house, we are able to retain as much control and value over our
own products as possible. The bridging trial has validated our in-house
manufacturing process and we have successfully crossed this major hurdle in the
development of ChimeriVax-JE, which is one of our key development programmes. We
are now looking forward to initiating our pivotal Phase lll trials before the
end of the year."
-ends-
Enquiries:
Acambis plc
Gordon Cameron, Chief Executive Officer: Tel +1 (617) 761 4200
David Lawrence, Chief Financial Officer: Tel: +44 (0) 1223 275 300
Lyndsay Wright, VP, Communications and Investor Relations:
Tel +44 (0) 1223 275 300
Financial Dynamics
David Yates/Lucy Briggs: 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 "Rick Factors" in the 2004 Form 20-F, 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.
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: 23 August 2005 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and Investor Relations