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 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 encouraging safety and immunogenicity results from Phase 2
study of MVA3000 smallpox vaccine
Cambridge, UK and Cambridge, Massachusetts - 31 July 2006 - Acambis plc
(Acambis) (LSE: ACM, NASDAQ: ACAM) announces preliminary results from a Phase 2
trial of its Modified Vaccinia Ankara (MVA) smallpox vaccine, MVA3000. Acambis
is co-developing MVA3000 with Baxter Healthcare SA ("Baxter"), which is
providing process development and manufacturing services.
MVA3000 is an attenuated smallpox vaccine that 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.
Acambis was awarded contracts by the US National Institute of Allergy and
Infectious Disease ("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 1 and Phase 2 clinical trials.
In total, 590 healthy adult subjects were enrolled in this randomised,
double-blind, placebo-controlled Phase 2 trial, which tested multiple dose
levels of MVA3000 against placebo. Of the enrolled subjects, 361 had never
received a smallpox vaccine (i.e., were "vaccinia naive"), and 229 had
previously been vaccinated against smallpox. This was the first trial in which
the safety and immunogenicity of MVA3000 had been tested in subjects previously
vaccinated against smallpox.
In vaccinia naive subjects vaccinated at the highest dose level, immunogenicity
results were consistent with the findings from the Phase 1 trial of MVA3000 with
75% of subjects seroconverting (i.e., experiencing a four-fold increase or above
in neutralising antibodies to vaccinia virus) after two doses. In previously
vaccinated subjects, 88% of subjects vaccinated at the highest dose level
seroconverted after two doses. The neutralising antibody levels necessary to
protect against smallpox are unknown.
No subjects experienced vaccine-related serious adverse events and most of the
adverse events were mild or moderate in nature. Despite active solicitation of
cardiac-related adverse events, no subjects were diagnosed with myocarditis or
pericarditis during this study. Among the subjects receiving MVA3000, the most
commonly reported adverse events were events traditionally associated with
smallpox vaccination and included injection site reactions (pain, redness,
swelling and itching), headache, fatigue, malaise and muscle ache.
Chief Executive Officer Gordon Cameron commented:
"With these Phase 2 clinical trial results, we achieve another milestone in our
programme to develop MVA3000. Both the safety and immunogenicity results are in
line with our expectations about MVA3000, with the results from our Phase 1
trial of the vaccine and with previous data on other MVA vaccines."
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/Anna Keeble
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 and is
manufacturing emergency-use stockpiles of this investigational vaccine for the
US Government and other governments around the world. 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 seven 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, was worth
$76m and required clinical testing and manufacture of 500,000 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 2005 Annual Report and its 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: 31 July, 2006 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.