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Xenova Group plc (XEN)

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Monday 14 February, 2005

Xenova Group plc

TransMID(TM) Obtains Orphan Drug Designation in...

Slough, UK, 14 February 2005 - Xenova Group plc (NASDAQ: XNVA; London
Stock Exchange: XEN) today announced that, Sosei Co. Ltd. (Sosei)
(4565, Tokyo Stock Exchange MOTHERS Index), its licensee for the
Japanese market, has been granted orphan drug status for the use of
TransMID(TM) in the treatment of glioma (a type of brain cancer) by
the Ministry of Health, Labour and Welfare (MHLW) in Japan.

TransMID(TM) is Xenova's lead product candidate currently in Phase
III trials for the treatment of glioblastoma multiforme.  The
achievement of orphan drug designation triggers a milestone payment
from Sosei to Xenova.

Orphan drug designation will facilitate the initiation of clinical
trials by Sosei and provide fast track approval process by the MHLW
once trials have been completed and a dossier seeking marketing
approval has been filed.

David Oxlade, Chief Executive Officer of Xenova said: "We welcome the
decision to grant orphan drug designation to TransMID(TM) in Japan.
Glioblastoma multiforme is an indication that is very poorly served
by current treatments. TransMID(TM) has already demonstrated
significant improvement over existing treatments in Phase II clinical
trials increasing median survival for patients from a historical
average of 26 weeks up to 37 weeks.  The positive response from the
MHLW in Japan, following that from the FDA and the EMEA, underlines
the potential for TransMID(TM) in the worldwide market for brain
tumour treatment."

Mr. Shinichi Tamura, President & CEO of Sosei, commented: "This
orphan drug status is a significant step for the development and
commercialisation of TransMID(TM) in Japan and we will do our best to
bring this product to patients as soon as possible."

Notes to Editors

Orphan designation in Japan
There are few incentives for industry to undertake the research,
development and marketing of drugs for small patient populations.
The orphan drugs system is intended to encourage the pharmaceutical
industry to undertake the work on these drugs for the treatment of
rare diseases.

MHLW designates a drug as an orphan drug according to the following

1.  Patient population less than 50,000
2. No alternative drugs are available or much higher efficacy or
safety compared to existing drugs
3. Theoretical basis for the application and a feasible plan to

Orphan designated drugs may receive the following support measures
from the government:

1.     Grant money up to a half of the development study costs
2.      Tax deduction
3.      Free advice for studies for IND/NDA
4.      Prioritised examination for NDA
5.     Extended re-examination period up to 10 years (period when
generics cannot appear)

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.  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. 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.
 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 or recurrent GBM who
have failed conventional therapy with the first patient dosed in July
2004.  The study will be a randomised, open-labelled, multi-centre
trial and will 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

Sosei Co. Ltd. founded in 1990 by Shinichi Tamura, the ex-CEO of
Genentech Japan, is a leading Japanese biopharmaceutical company with
significant expertise in drug development.  It enriches its core
product pipeline by in-licensing compounds from Western and Japanese
companies, by its distinctive Drug Reprofiling Platform� (DRP�) and
through new molecular entity (NME) research programmes in
collaboration with biopharmaceutical companies and universities both
in Japan and the West. Sosei is also developing its own sales and
marketing organization in Japan. The company is capitalising on its
extensive global network established over the past 10 years in its
successful technology transfer business. For further information
about Sosei, please visit

This press release contains "forward-looking statements," including
statements about the development and commercialization of product
candidates. Various risks may cause Xenova's actual results to differ
materially from those expressed or implied by the forward looking
statements, including: the possibility of unsatisfactory results from
further clinical testing, failure to receive full regulatory
approvals on a timely basis or at all, the inability to obtain
effective protection of intellectual property, the successful
development and commercialization of competing products by other
companies and our dependence upon strategic alliance partners to
develop and commercialize products and services.  For further
information concerning 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
David Yates
Ben Atwell

US - Trout Group/BMC Communications
+1 212 477 9007
Media: Brad Miles
Investors: Lee Stern



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