Information  X 
Enter a valid email address

Xenova Group PLC (XEN)

  Print      Mail a friend

Friday 28 June, 2002

Xenova Group PLC

Research Update

Xenova Group PLC
28 June 2002

                                                           FOR IMMEDIATE RELEASE

                                  Xenova Group plc

                       Phase III Trials Begin for Tariquidar

Slough, UK, June 28th, 2002 - Xenova Group plc (NASDAQ NM: XNVA; London Stock
Exchange: XEN) today announces that patient enrolment has begun in two pivotal
Phase III clinical trials for tariquidar, in which tariquidar is being used as
an adjunctive treatment in combination with first-line chemotherapy for
non-small cell lung cancer (NSCLC) patients.  Discovered by Xenova, tariquidar,
a P-glycoprotein (P-gp) inhibitor, is being developed for the treatment of
multidrug resistance (MDR) in cancer with QLT Inc. (NASDAQ: QLTI; TSE: QLT),
Xenova's partner for North America.

The two double-blind, randomised, placebo-controlled trials are being carried
out in patients with stage IIIb/IV NSCLC at approximately 100 centres located
throughout North America and Europe.  Patients will receive as first-line
therapy paclitaxel/carboplatin and either tariquidar or placebo in one trial and
vinorelbine and either tariquidar or placebo in the second.  Approximately 1,000
patients will be recruited in total. The trials are designed to demonstrate the
ability of tariquidar to enhance the effectiveness of chemotherapeutic agents
affected by MDR and the primary end-point of both trials is overall survival.
An interim analysis is planned for mid-2003.

It is anticipated that, on successful completion of the Phase III programme, QLT
will file for approval of tariquidar in North America for use in combination
with first-line chemotherapy in advanced NSCLC by the end of 2005.  NSCLC is the
first of several indications for which tariquidar will be investigated.  A Phase
IIb trial with tariquidar in patients with refractory breast cancer is also
underway at the University of Texas MD Anderson Cancer Center.

In August 2001, Xenova signed an exclusive licence agreement with
Vancouver-based QLT Inc (Nasdaq MN: QLTI; TSE: QLT) for the development and
marketing in the United States, Canada and Mexico of Xenova's P-gp inhibitor,
XR9576 (tariquidar) for the treatment of MDR in cancer.  Under the terms of the
agreement, QLT have assumed responsibility for the further development of
tariquidar, including Phase III trials, all regulatory filings and the
manufacture and sale of tariquidar within those territories covered by the
agreement.  QLT made an immediate upfront licence payment to Xenova of US$10m
(£7.1m) and will provide up to US$45m (£32.0m) in funding for all development
activities related to Phase III clinical studies for tariquidar in North America
and Europe.  Milestones of up to US$50m (£35.6m) and royalties in the range of
15 to 22 per cent depending on the level of North American sales are also
receivable by Xenova.

Xenova retains substantially all commercial rights to tariquidar outside the
United States, Canada and Mexico, including European and Rest of World marketing

David Oxlade, Chief Executive of Xenova, commented:

'There is increasing evidence of the rationale for this approach to the
treatment of non-small cell lung cancer. For example, in one independent study,
patients whose tumours were P-gp negative had a significantly longer survival
time than patients whose tumours were P-gp positive. Together with our partner,
QLT, good progress has been made in the 10 months since the signing of our
licence agreement and we are pleased that tariquidar has entered clinical
registration studies on schedule.'

Paul J. Hastings, President and CEO of QLT Inc, said:

'We are extremely pleased to begin the Phase III trials for tariquidar on time
and to have reached another critical milestone in our development pipeline. We
believe tariquidar has the potential to be QLT's next big success story.'


UK:                                                 US:
Xenova Group plc                                    Trout Group/BMC Communications
Tel: +44 (0)1753 706600                             Tel: 001 212 477 9007
David A Oxlade, Chief Executive Officer             Press: Brad Miles (Ext 17) Lauren Tortorete (Ext 20)
Daniel Abrams, Group Finance Director               Investors: Jonathan Fassberg (Ext 16) Lee Stern (Ext 22)
Hilary Reid Evans, Corporate Communications

Financial Dynamics
Tel: +44 (0)207 831 3113
David Yates/Fiona Noblet

Media: Tamara Hicks, Tel 001 604 707 7316
Investors: Therese Crozier or Tamara Hicks

Tel 001 604 707 7000

Notes to Editors

Xenova Group plc's product pipeline focuses principally on the therapeutic areas
of cancer and immune system disorders.  Xenova currently has a broad pipeline of
eight programmes in clinical development.  The Group has a well-established
track record in the identification, development and partnering of innovative
products and technologies and has partnerships with major pharmaceutical
companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium

Tariquidar - One of the major barriers to successful cancer chemotherapy is the
development by cancer cells of resistance to those drugs being used for
treatment.  Tariquidar targets this drug resistance mechanism through the
inhibition of P-glycoprotein, a membrane based 'pump' that acts to expel the
cytotoxic drug from the tumour cell, preventing the cytotoxic drug from being
fully effective.  Tariquidar has completed a series of three separate Phase IIa
trials, in which tariquidar was administered together with three of the world's
best-selling cytotoxic drugs, each of which is known to be affected by the
resistance mechanism.  The successful outcome of these trials was announced in
late 2000/early 2001.  The trials demonstrated that the combination of
tariquidar with the cytotoxic drug was safe and well tolerated and that no
clinically significant pharmacokinetic interaction occurred between tariquidar
and the cytotoxic drug.  This allows the cytotoxic drug to be administered at or
close to its full normal clinical dose, which is of potentially significant
therapeutic benefit.  A number of complete and partial responses (elimination or
shrinkage of the tumour) were observed to occur during these open label and
uncontrolled studies.

For further information about Xenova and its products please visit the Xenova
website at

Lung Cancer - In the United States, a total of 169,500 new cases of lung cancer
were estimated for 2001, accounting for 13% of cancer diagnoses.  Lung cancer is
the leading cause of cancer-related death in the United States, accounting for
over 30% of cancer deaths in men and 25% in women.  NSCLC accounts for
approximately 80% of all lung cancer cases.

QLT Inc is a global biopharmaceutical company dedicated to the discovery,
development and commercialisation of innovative therapies to treat cancer, eye
diseases and immune disorders.  Combining expertise in opthalmopogy, oncology
and photodynamic therapy, QLT has commercialised two products to date, including
Visudyne(R) therapy which is the largest selling ophthalmology product ever
launched.  For more information you are invited to visit QLT's website at

For Xenova: Disclaimer to take advantage of the 'Safe Harbor' provisions of the
US Private Securities Litigation Reform Act of 1995. This press release contains
'forward-looking statements,' including statements about the discovery,
development and commercialisation of products. Various risks may cause Xenova's
actual results to differ materially from those expressed or implied by the
forward looking statements, including: adverse results in our drug discovery and
clinical development programs; failure to obtain patent protection for our
discoveries; commercial limitations imposed by patents owned or controlled by
third parties; our dependence upon strategic alliance partners to develop and
commercialise products and services; difficulties or delays in obtaining
regulatory approvals to market products and services resulting from our
development efforts; the requirement for substantial funding to conduct research
and development and to expand commercialisation activities; and product
initiatives by competitors.  For a further list and description of the risks and
uncertainties we face, see the reports we have filed with the Securities and
Exchange Commission.  We disclaim any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.

                      This information is provided by RNS
            The company news service from the London Stock Exchange