Xenova Group PLC
26 October 2001
For Immediate Release
Xenova Group plc
Successful Results of Phase IIa and Phase I HPV-Related Clinical Trials
Start of Combined 'Prime-Boost' Phase II Trial
Slough, UK, 26th October 2001 - Xenova Group plc (Nasdaq NM: XNVA; London
Stock Exchange: XEN) today announced the successful results of clinical trials
for two of its vaccines for the treatment of human papillomavirus (HPV)
associated diseases. HPV infection is a recognised risk factor in both anal
and genital cancers.
Successful Results of Phase IIa trial of TA-HPV
Results from a physician-initiated Phase IIa trial of Xenova's TA-HPV vaccine
in women with high grade vulval intra-epithelial neoplasia (VIN 3), part of a
group of conditions known collectively as ano-genital intraepithelial
neoplasia (AGIN), were presented at the 19th International Human
Papillomavirus Conference (September 2001).
The 18-patient study, which was conducted by researchers at St Mary's
Hospital, Manchester and the Paterson Institute for Cancer Research,
Manchester, showed that the vaccine was safe and well tolerated. Forty-four
per cent of patients demonstrated an objective clinical response at six months
and a further twenty-two per cent showed significant symptom relief. A
further Phase IIa AGIN study is ongoing at Addenbrooke's Hospital, Cambridge,
UK and is due to be completed in the near future.
VIN 3 is a high-risk human papillomavirus (HPV) associated condition. The
incidence of VIN has increased over the last 20 years, particularly in younger
women. VIN 3 is difficult to treat, has a high recurrence rate and is a
condition that can progress to cancerous disease.
Successful Results of Phase I trial of TA-CIN
The successful results of a Phase I safety and immunogenicity study for
TA-CIN, a Xenova vaccine which is being developed for the treatment of
cervical intraepithelial neoplasia (CIN), a further AGIN condition, were also
presented at the recent Human Papillomavirus Conference. In this
placebo-controlled, dose-escalating study, the vaccine was administered by
intramuscular injection to 40 healthy volunteers. TA-CIN was found to be very
well tolerated. No serious adverse events were reported during the study. The
vaccine was also found to be immunogenic. TA-CIN specific antibody responses,
and positive T cell responses were seen in all of the cohorts receiving active
Phase II 'Prime Boost' Clinical Trial Begins
Preclinical studies, conducted by Xenova in conjunction with scientists at the
Leiden University Medical Center, The Netherlands, have demonstrated that a
combination of TA-HPV and TA-CIN results in an immune response that is
significantly stronger than that observed with either product alone. Using
this 'prime-boost' immunisation regimen, the CD8+ T cell response, which is
believed to be important in controlling HPV infection, is increased 5-10 fold.
The results of this preclinical study were published in the June 1st 2001
issue of 'Vaccine'.
Based on the positive results of the TA-HPV and TA-CIN clinical studies to
date and on the significant preclinical combination study, a 'prime-boost'
Phase II clinical trial, in which TA-HPV is given in combination with TA-CIN,
has now begun at 3 centres in the UK, Cambridge, Cardiff and Manchester. The
studies are being conducted in up to 30 women with HPV associated AGIN
conditions, excluding CIN. This will allow evaluation over a six month period
of the effect of the combined vaccination regime on disease progression.
David Oxlade, Chief Executive Officer of Xenova, commented:
'HPV has been linked to both AGIN and to ano-genital cancers. AGIN conditions
are highly recurrent, difficult to treat and have debilitating effects for
sufferers. The Prime-Boost study is designed to prime, focus and boost the
immune response against HPV infection in AGIN, using two vaccines in
combination. If successful, this approach will play a significant role in the
treatment of AGIN and prevention of related ano-genital cancers.'
Xenova Group plc Financial Dynamics
Tel: +44 (0) 1753 706600 Tel: +44 (0) 207 831 3113
David Oxlade: Chief Executive Officer David Yates/Fiona Noblet
Daniel Abrams: Finance Director
John St Clair Roberts: Medical Director
Hilary Reid Evans: Corporate Communications
Tel: 001 212 477 9007
Brad Miles (Ext 17)/Lauren Tortorete (Ext 20)
Notes to Editors
Xenova's product pipeline focuses principally on the therapeutic areas of
cancer, infectious, autoimmune and cardiovascular diseases. The Group has a
well-established track record in the identification, development and
partnering of innovative products and technologies. Xenova has partnerships
with a number of major pharmaceutical companies including Lilly, Pfizer,
Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova
website at www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of
1995: Some or all of the statements in this document that relate to future
plans, expectations, events, performances and the like are forward-looking
statements, as defined in the US Private Securities Litigation Reform Act of
1995. Actual results of events could differ materially from those described
in the forward-looking statements due to a variety of factors, including those
set forth in the Company's filings with the US Securities and Exchange