Slough, UK, 13 April 2005 - Xenova Group plc (NASDAQ: XNVA; London
Stock Exchange: XEN) today announced that it has entered into a
licensing agreement for its lead product candidate, TransMID(TM),
with PharmaEngine, Inc. (PEI) of Taiwan for the Chinese and South
Under the terms of the agreement, Xenova will receive an upfront
payment as well as milestone payments and significant royalties on
potential future sales. Xenova also retains manufacturing rights and
will be the exclusive supplier of TransMID(TM) to PEI. PEI receives
exclusive rights to develop, market and sell TransMID(TM) in both the
People's Republic of China and in the Republic of South Korea
following PEI sponsored registration trials in these countries.
PEI focuses on developing novel medications in the areas of oncology,
immune disorders infection, and Asian prevalent diseases. Dr. C.
Grace Yeh, CEO of PEI, said "We are excited to add a late stage
novel product candidate to our product portfolio. Notably, using
transferrin toxin conjugate to target tumour cells was the research
focus during my early career in the UK and France"
David Oxlade, CEO of Xenova said: "Today's announcement illustrates
the significant global potential for TransMID(TM) along with the
existing licences already granted for this exciting product
candidate. Recruitment on the Phase III trial is ongoing and we are
expecting an interim review around mid 2006."
Notes to Editors
Brain tumours in China:
The incidence of brain and CNS tumours in China is 29,739 per annum
(data from Globocan 2002). According to PharmaEngine's market survey
of major cities in China, the target patient number for TransMID(TM)
in 10-15 hospitals which have specialised neurosurgery teams for
brain tumours is in the region of 1500 per year.
Brain tumours in Republic of Korea
The incidence of all brain and CNS tumours in Korea is 992 per annum
(data from Globocan 2002), with an incidence of high grade glioma of
around 400 per year.
TransMID(TM) is being developed for the treatment of glioblastoma
multiforme (GBM) (a type of brain cancer). The prognosis for patients
is poor and it is a condition in which there has been little
improvement in treatment for the last two decades. TransMID(TM) is a
modified diphtheria toxin conjugated to transferrin. Transferrin
receptors are particularly prevalent on rapidly dividing cells, and
the high level of transferrin receptor expression on glioma cells
makes it an ideal target for brain cancer. The diphtheria toxin
gains entry to the tumour cell when the transferrin to which it is
attached binds to transferrin receptors on the surface of the tumour
cell. Once inside a cell the diphtheria toxin interferes with protein
synthesis which ultimately kills the cancer cell.
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 and produces high local
concentrations of drug. 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.
In a Phase II study, 50% or greater reduction in tumour volume was
noted in 35% of evaluable patients, with a corresponding increase in
life expectancy in those patients that did respond. Median survival
time for patients receiving TransMID(TM) was approximately 37 weeks.
This compares to the historic average life expectancy of
approximately 26 weeks for patients with this condition being treated
with best standard of care.
In May 2004 Xenova reached agreement with the US Food and Drug
Administration (FDA) under the Special Protocol Assessment (SPA)
procedure for the revised Phase III clinical trial programme proposed
for TransMID(TM). The initial Phase III clinical trial will enrol up
to 323 patients with non-resectable, progressive and/or recurrent GBM
who have failed conventional therapy with the first patient dosed in
July 2004. The study is a randomised, open-labelled, multi-centre
trial to compare TransMID(TM) against a number of presently used
chemotherapeutic agents regarded as Best Standard of Care. The 323
patients will be randomised in a 2:1 ratio of TransMID(TM) to Best
Standard of Care across approximately 65 sites in the EU, Israel and
North America. The primary end-point is overall survival time with a
planned interim analysis to be conducted after 50% of the required
events have been observed.
TransMID(TM) is currently licensed to Nycomed Denmark A/S 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 have been retained by Xenova Group plc.
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 candidate 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 75 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.com and www.gbmtrial.com
PharmaEngine Inc, located in Taipei, Taiwan, has in-licensed two
product candidates to develop, manufacture, market and sell in the
Asian territory (including Japan). The company is developing PEP02
for the treatment of cancers and PEP03 for respiratory indications
which are in Phase I and Phase II trials respectively. For more
information, please visit www.pharmaengine.com.
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: difficulties or delays in obtaining regulatory approvals
to market products, our dependence upon strategic alliance partners
to develop and commercialize products and services, failure to
achieve product development or commercialization milestones on a
timely basis or at all and adverse results and delays in our drug
discovery and clinical development programs as well as the
requirement for substantial funding to conduct such activities. For
a further list and description of the risks and uncertainties we
face, see our reports on file 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
---END OF MESSAGE---