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 July 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:
'Statement re Clinical Trial'
Acambis announces start of MVA3000 Phase II trial
Cambridge, UK and Cambridge, Massachusetts - 14 July 2005 - Acambis plc
("Acambis") (LSE: ACM, NASDAQ: ACAM) today announces that it has commenced a
Phase II clinical trial of its investigational MVA smallpox vaccine, MVA3000.
Acambis is co-developing MVA3000 with its process development and manufacturing
partner Baxter Healthcare SA ("Baxter").
MVA vaccines are a weakened form of smallpox vaccine. MVA3000 is being developed
for use in people for whom the traditional smallpox vaccine is contraindicated,
such as patients with disorders of the immune system or skin conditions such as
eczema. The US Government plans to procure a stockpile of MVA as part of its
defence against the threat of smallpox virus being used as a bioterrorist
weapon.
The Phase II trial is designed to gather further safety and immunogenicity data
about MVA3000 when administered at three different dose levels. The randomised,
double-blind, placebo-controlled study will involve 700 healthy adult subjects,
half of whom have been previously vaccinated against smallpox, and is being
conducted at up to 10 sites in the US. Each subject will receive two doses of
either MVA3000 or placebo, and the MVA3000 inoculations will be given across a
broad range of doses. Data from this study will be used to select a dose of
MVA3000 for further clinical testing.
In April, Acambis announced results from a Phase I safety and immunogenicity
trial of MVA3000, in which 97% of subjects vaccinated at the highest dose level
seroconverted to vaccinia virus-specific antibodies (determined by enzyme-linked
immunosorbent assay) and 82% seroconverted to vaccinia neutralising antibodies
(determined by plaque-reduction neutralisation testing) after two doses. No
subjects experienced unexpected or serious adverse events.
Acambis' Chief Executive Officer Gordon Cameron commented:
"The MVA3000 trial results to date have been exactly in line with our
expectations of the vaccine's profile and we are confident this will continue in
our Phase II trial. Under existing contracts with the US Government, we are also
preparing for additional Phase I/II trials in target population subjects with
HIV and atopic dermatitis and remain on schedule to commence these later this
year.
"In the meantime, we look forward to the US Government's issuance of an RFP for
a stockpile of MVA vaccine. Having already delivered more than 180 million doses
of our investigational ACAM2000 smallpox vaccine to the US stockpile, we bring
unmatched experience to the US Government's efforts to create a stockpile of MVA
vaccine. Our experience, combined with our ability to manufacture to commercial
scale through our partnership with Baxter, puts us in a very strong position to
bid for supply of the US MVA stockpile."
Acambis was awarded contracts by the US National Institute of Allergy and
Infectious Diseases ("NIAID"), part of the US National Institutes of Health, in
February 2003 and September 2004 for the manufacture of MVA3000 and a series of
Phase I and Phase II clinical trials. The Phase II trial and subsequent Phase I/
II target population trials of MVA3000 are part of the second NIAID contract.
Enquiries
Acambis:
Gordon Cameron, Chief Executive Officer
Tel: +1 (617) 761 4200
David Lawrence, Chief Financial Officer
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 47 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.
About Acambis' NIAID contracts
Acambis has been awarded two contracts by the NIAID for the manufacture and
development of its MVA smallpox vaccine, MVA3000. The first contract, awarded in
February 2003, was for $9.2m. The second, awarded in September 2004, is
potentially worth up to $131m, with a $76m core component requiring clinical
testing and manufacture of 500,000 doses of MVA3000, and an optional element
worth $55m for the manufacture of a further 2.5 million doses of MVA3000.
"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.
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: 14 July 2005 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: Director of Communications