Xenova Group PLC
18 October 2000
Xenova Group plc: XR9576 Phase II Cancer Programme Update
Further positive Phase IIa trial results
Slough, UK, 18 October 2000
Xenova Group plc (Nasdaq: XNVA) (London Stock Exchange: XEN) today announced a
programme update for its Phase II clinical trial candidate, XR9576.
A positive outcome has been confirmed in the second of three Phase IIa PK
(pharmacokinetic) trials, in which XR9576 was administered in combination
therapy with doxorubicin, one of the world's most frequently used cytotoxic
drugs. XR9576 is a P-glycoprotein pump (P-gp) inhibitor, designed to address
the problems of multi-drug resistance in cancer. It is estimated that,
depending on the type of cancer, between 30% and 80% of cancer patients
develop resistance to anti-cancer drugs. The most common form of this
resistance is the over-production of a membrane protein, known as P-gp, which
pumps anti-cancer drugs out of cells.
This XR9576/doxorubicin study is the second to be completed in a series of
three trials designed to assess the level of drug:drug interaction, if any,
between XR9576 and the cytotoxic in question. The positive results of a Phase
IIa PK study, in which XR9576 was administered with paclitaxel, the world's
leading selling cancer drug, and which was carried out in relapsed ovarian
cancer patients, were reported in March 2000. In the paclitaxel study, XR9576
showed no clinically significant PK interaction, allowing paclitaxel to be
administered at its full clinical dose.
Commenting on the doxorubicin study, principal investigator Dr David Ferry, of
the Queen Elizabeth Medical Centre, Birmingham, UK said: 'We are very pleased
with the outcome of this study. P-gp has been a difficult area to work in,
with variable and in some cases significant interactions observed between many
of the previously investigated P-gp inhibitors and the co-administered
cytotoxics. However, this trial has shown XR9576 to have only minor and
predictable effects when used with doxorubicin. XR9576's lack of variable and
clinically significant PK interaction should provide an advantage in clinical
practice, in that it could allow many different cytotoxic drugs to be used at
or close to their normal doses.'
Dr Hilary Thomas, Professor of Oncology at the Royal Surrey Hospital,
Guilford, UK and principal investigator for the paclitaxel/ovarian trial,
commented saying: 'Ideally, multi-drug resistance modulators should allow
cytotoxic drugs to be administered at or as close as possible to their normal
dosing levels. In the study, which we completed earlier this year in relapsed
ovarian patients, XR9576 showed no sign of toxicity associated with XR9576
itself and no sign of clinically significant effects on paclitaxel levels.
This allowed us to use paclitaxel at its full normal dosing levels, a
potentially important and differentiating capability.'
A third Phase IIa study, in which XR9576 is being administered in combination
with vinorelbine, another leading cancer drug, is scheduled for completion
shortly. This study is being carried out at the National Cancer Institute in
As previously reported, it is expected that XR9576 will be ready to enter
pivotal Phase III clinical trials by the end of 2000. The positive outcome of
the doxorubicin PK study, as announced today, provides additional clinical
options for the design of these Phase III studies.
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc, said:
'Multi-drug resistance remains one of the major barriers to treatment in many
forms of cancer. We are delighted with the continued progress shown by
Xenova Group plc
Tel: +44 (0)1753 706600
David A Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Hilary Reid Evans, Corporate Communications
Noonan/Russo Communications Inc
Tel: 001 212 696 4455
Tony Ho Loke (Media)
Tel: +44 (0)20 7831 3113
Xenova Group plc is a London Stock Exchange techMARK listed company.
Notes to Editors
Xenova Group plc is an emerging bio-pharmaceutical company specialising in the
development of new small molecule drugs. The company's strategy is to develop
commercially attractive new drugs, primarily in the area of cancer
In addition to its two Phase II programme drugs (XR9576 and topoisomerase I
and II inhibitor XR5000) Xenova is also currently undertaking cancer research
projects targeting MRP-related multi-drug resistance, further next generation
topoisomerase inhibitors, telomerase (with Brunel University) and plasminogen
activator inhibitor-1 (PAI-1). Xenova has a drug development agreement with
Lilly, based on small molecule inhibitors of PAI-1, to develop novel
antithrombotic drugs for chronic use.
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