Xenova Group plc
Tariquidar Phase I Paediatric Study
Data Presented at ASCO
Abstract on XR5944 also presented
Slough, UK, 7 June 2004 - Xenova Group plc (London Stock Exchange:
XEN; NASDAQ: XNVA) announced today that the Paediatric Oncology
Branch of the National Cancer Institute (NCI) in Bethesda, US,
yesterday presented a poster at the American Society of Clinical
Oncology (ASCO) conference in New Orleans, Louisiana on the
paediatric Phase I clinical trial of tariquidar in children with
The primary objectives of this trial were to assess the toxicity,
optimal dose and pharmacokinetics of tariquidar in children with
solid tumours and to assess the toxicity and pharmacokinetics of the
anti cancer drugs in combination with tariquidar. A total of 18
children have been enrolled into the study to date, between the ages
of 2 and 18 with a range of tumours including Ewing's Sarcoma,
osteosarcoma and adrenocortical carcinoma amongst others.
Tariquidar was administered intravenously over 30 minutes with a
starting dose of 1mg/kg in four patients and then escalated to
1.5mg/kg in six patients and then to 2.0mg/kg in the eight remaining
patients. This was followed by administration of the anti-cancer
drug which was chosen on the basis of tumour type and prior therapy.
Doxorubicin was administered to 11 patients at 50mg/m2, docetaxel was
administered to four patients at 75mg/m2 and vinorelbine was
administered to two patients at 20mg/m2 on days one and eight.
Fligrastim was administered to all patients during the 21 day cycle.
The results of the study showed that tariquidar was well tolerated in
children. Of the 18 subjects enrolled, one patient had a complete
response, one had a partial response and five had stable disease for
one to eight cycles of therapy. Doxorubicin clearance was comparable
to previously published results indicating the clearance of
doxorubicin was not altered by pre-treatment with tariquidar. The
future development of tariquidar by Xenova is currently under review.
Commenting on these results, David Oxlade, Chief Executive Officer of
Xenova, said, "It is encouraging to see these results in children
with solid tumours. The NCI is undertaking a number of exploratory
clinical trials with tariquidar in both adults and children and we
look forward to further results from these studies."
In addition to this poster, Xenova and Millennium have an abstract
published relating to the on-going Phase I study of XR5944 at the
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
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 LN)
For further information about Xenova and its products please visit
the Xenova website at www.xenova.co.uk.
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.
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