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 October 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
Positive results from pivotal Phase 3 trials of Acambis' JE vaccine
Cambridge, UK and Cambridge, Massachusetts - 30 October 2006 - Acambis plc
(Acambis) (LSE: ACM, NASDAQ: ACAM) announces positive results from its pivotal
Phase 3 safety trial of ChimeriVaxTM-JE, its investigational single-dose vaccine
against Japanese encephalitis (JE) and encouraging preliminary data from its
Phase 3 efficacy trial.
The pivotal Phase 3 multi-centre safety trial evaluated the safety and
tolerability of ChimeriVax-JE in healthy adults. A total of 2,004 subjects were
enrolled into the randomized, double-blind placebo-controlled trial and the
ratio of individuals receiving ChimeriVax-JE to placebo was 4:1. The trials were
conducted in the US and Australia.
The primary endpoint of the study was the incidence of adverse events 30 days
after vaccination. Results show that the total number of subjects reporting
adverse events was comparable between subjects vaccinated with ChimeriVax-JE and
those who received placebo. Vaccination with ChimeriVax-JE was systemically and
locally well tolerated. The majority of adverse events were mild or moderate in
nature, with headache and fatigue being the most frequently reported events.
There was one serious adverse event considered to be vaccine-related. This
event, febrile illness, resolved without complications.
The pivotal Phase 3 multi-centre efficacy trial was designed to test the
non-inferiority of ChimeriVax-JE to a licensed JE vaccine, JE-VAX(R). The study
called for 816 subjects to be vaccinated, 408 with ChimeriVax-JE and 408 with
JE-VAX, which would enable a statistical comparison of immunogenicity to be
made. While the trial is still blinded, early serology data indicate an overall
seroconversion rate of approximately 98% in evaluable subjects receiving either
a single dose of ChimeriVax-JE or three doses of JE-VAX. Full results from the
efficacy trial are expected in the first quarter of 2007.
Acambis' Chief Executive Officer Gordon Cameron commented:
"We are delighted to report these positive Phase 3 safety results and
encouraging preliminary efficacy data. Together, they represent another major
advance in the successful development of ChimeriVax-JE and move us another step
closer to providing a convenient, affordable, single-dose vaccine to travellers
and those living in JE-endemic regions."
There is a global public health need for a safe and effective single-dose
vaccine against JE. This need is particularly significant in endemic areas like
India where such a vaccine could represent a major contribution to preventing JE
in children.
Acambis has a marketing and manufacturing agreement with a leading Indian
biopharmaceutical company, Bharat Biotech, and is actively pursuing partnerships
to support licensure and marketing of ChimeriVax-JE in other markets.
Enquiries:
Acambis plc:
Lyndsay Wright, VP, Communications and IR
Tel: +44 (0) 1223 275 300
Financial Dynamics
David Yates/Anna Keeble
Tel: +44 (0) 20 7831 3113
Notes to editors:
Japanese encephalitis
Japanese encephalitis is a virus transmitted to humans by mosquitoes and is the
leading cause of childhood encephalitis and viral encephalitis in Asia. Last
year, a JE epidemic affecting areas of northern India and Nepal, resulted in
6,340 cases and more than 1,200 deaths, mostly of children. Every year, there
are an estimated 30,000 to 50,000 cases of JE, approximately 25-30% of which are
fatal; a high proportion of survivors are left with serious neurological
impairment.
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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 based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). Its shares are listed on NASDAQ
(ACAM) in the form of American Depositary Receipts. 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 2005 Annual Report and "Risk factors" in 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: 30 October 2006 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.