TransMID(TM) - First Patient Treated in Pivotal Phase III GBM Trial
Slough, UK, 7 June 2004 - Xenova Group plc (London Stock Exchange:
XEN; NASDAQ: XNVA) announced today that patient dosing has begun in
the Phase III clinical trial of TransMID(TM) for the treatment of
progressive or recurrent non-operable Glioblastoma Multiforme (GBM).
The first patient was enrolled at University of Utah Huntsman Cancer
Institute in the US.
On 11 May 2004, Xenova and the FDA reached agreement under the
Special Protocol Assessment procedure for the revised Phase III
clinical trial programme for TransMID(TM).
The Phase III clinical trial will enrol up to 323 patients with
non-resectable, progressive or recurrent Glioblastoma Multiforme (the
most common form of high-grade glioma or brain cancer), who have
failed conventional therapy. The study is a randomised,
open-labelled, multi-centre trial designed to compare TransMID(TM)
against a number of presently used chemotherapeutic agents regarded
as "best standard of care" (BSC). The 323 patients will be
randomised in a 2:1 ratio of TransMID(TM) to BSC across 29 centres in
the EU, 4 in Israel and 21 in North America.
In an earlier Phase II study involving 44 patients, a 50% or greater
reduction in tumour volume was noted in 35% of evaluable patients.
In this study, median survival for patients receiving TransMID(TM) on
an intent to treat (ITT) basis was approximately 37 weeks. This
compares to a historical average life expectancy of approximately 26
weeks for patients being treated with best standard of care, as
determined from the literature.
William Broaddus, MD, PhD, Associate Professor of Neurosurgery at
Virginia Commonwealth University Health System (Richmond, Virginia)
and Chair of the Executive Steering Committee for the TransMID(TM)
Phase III trial said "This toxin conjugate has shown unprecedented
results in Phase I and II trials with tumors that are notoriously
difficult to treat. The novel therapeutic agent and the innovative
delivery strategy represent significant milestones in our search to
find better ways of treating these devastating tumors. I am very
pleased to see the start of this promising Phase III trial."
David A. Oxlade, Chief Executive Officer said "We are pleased to have
our first patient dosed, having recently reached agreement with the
FDA on the revised SPA for TransMID(TM). Patients with inoperable or
recurrent brain tumours currently have very limited therapeutic
alternatives, and there remains a serious need to provide improved
outcomes for these individuals."
Xenova Group plc is a UK-based biopharmaceutical company focused on
the development of novel drugs to treat cancer and addiction with a
secondary focus in immunotherapy. The Company has a broad pipeline
of products in clinical development, including three cancer
programmes: its lead product TransMID(TM), for the treatment of
high-grade glioma, is in Phase III trials, and its novel DNA
targeting agents and XR303 are both in Phase I for cancer
indications. Xenova is also developing two therapeutic vaccines for
cocaine and nicotine addiction, which are in Phase II and Phase I
trials respectively. Quoted on the London Stock Exchange (XEN) and
on NASDAQ (XNVA), Xenova employs approximately 112 people throughout
its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN
For further information about Xenova and its products please visit
the Xenova website at www.xenova.co.uk.
Notes to Editors
Information on this trial as well as others can be found on:
www.cancerhelp.org.uk (an information service about cancer and
cancer care for people with cancer and their families brought to
people by Cancer Research UK)
www.clinicaltrials.gov (a service of the National Institutes of
Health (US government) to provide information about federally and
privately supported clinical research)
Xenova takes no responsibility for the information enclosed in these
TransMID(TM) is a treatment initially being developed for high-grade
glioma (a type of brain cancer), a disease for which improved
treatment is essential, as there remains a poor prognosis for
patients. TransMID(TM) is a modified diphtheria toxin conjugated to
transferrin. When TransMID(TM) binds to transferrin receptors on the
surface of the cell, the diphtheria toxin gains entry to the cell.
Once inside the cell, the diphtheria toxin interferes with protein
synthesis and ultimately kills the cell. Transferrin receptors are
particularly prevalent on rapidly dividing cells, and the high level
of transferrin receptor expression on glioma cells relative to normal
brain tissue makes transferrin an appropriate targeting mechanism for
the diseased cells.
TransMID(TM) is pumped directly into the brain tumour using CED
(Convection Enhanced Delivery - licensed from the National Institutes
of Health, Bethesda, Maryland, USA). CED enhances the distribution
of TransMID(TM) through the tumour mass, producing high local
concentrations of drug and reducing systemic side effects. This also
has the benefit of circumventing the usual obstacles present in drug
delivery to the brain caused by the blood-brain barrier.
Phase I and Phase II clinical trials for TransMID(TM) have been
successfully completed in patients suffering from inoperable,
recurrent high grade gliomas who have failed to respond to other
forms of treatment. A Phase I dose-escalating study was performed at
the National Institutes of Health in the US and was followed by a
Phase II multi-centre study at nine premier US medical centres.
Marketing rights to TransMID(TM) have been licensed to Nycomed
Danmark ApS in Europe, Sosei Co Ltd in Japan, Medison Pharma Ltd in
Israel and Ranbaxy Laboratories Limited in India. The rights to
TransMID(TM) in North America and other territories have been
TransMID(TM) received Fast Track status from the FDA in August 2001
and orphan drug status in December 2001. In addition, the European
Commission granted TransMID(TM) orphan designation in March 2002.
Convection Enhanced Delivery
Convection enhanced delivery (CED) involves the slow continuous
infusion of TransMID(TM) over several days via one or more catheters
directly into the tumour. This technique maximises perfusion of the
drug into the target area. Xenova has licenses from the NIH for the
use of CED and TransMID(TM) in cancers of the CNS, head and neck.
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 development and commercialization of
products. Various risks may cause Xenova's actual results to differ
materially from those expressed or implied by the forward looking
statements, including: unexpected costs and delays, 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
commercialize 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
commercialization 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.
Xenova Group plc
+44 (0)1753 706600
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
UK - Financial Dynamics
+44 (0)20 7831 3113
US - Trout Group/BMC Communications
+1 212 477 9007
Media: Brad Miles
Investors: Lee Stern
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