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2005/OB/16
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OXFORD
BIOMEDICA TO PRESENT NEW TROVAX® DATA FROM
PHASE II TRIALS IN COLORECTAL CANCER AT THE 2005 ASCO ANNUAL
MEETING ON 15 MAY
Oxford
BioMedica (LSE: OXB), the leading gene therapy company, today
announced that new data from the Phase II trials of TroVax,
its cancer immunotherapy, in colorectal cancer will be presented
on 15 May at the 2005 American Society of Clinical Oncology
(ASCO) Annual Meeting taking place in Orlando, Florida, USA,
on 13-17 May 2005. Details are as follows:
"An Open
Label Phase II Study of MVA Expressing the Tumour Antigen
5T4 Given in Conjunction with Chemotherapy: Safety and Immunogenicity
Before, During and After Chemotherapy." (Abstract #30642)
Session: Developmental
Therapeutics, Immunotherapy
Sunday 15 May, 8:00 am - 12:00 noon, Level 2, Hall C, H10
This abstract may
be accessed online at http://www.asco.org/ at the conclusion
of the meeting.
The presentation
describes two Phase II trials of TroVax in first line treatment
of metastatic colorectal cancer alongside irinotecan-based
(IFL) and oxaliplatin-based (FOLFOX) chemotherapy. Oxford
BioMedica previously reported encouraging results from the
trials in March 2005. The new data include analysis of immune
responses and clinical benefit.
Enrolment in the
trials was completed in September 2004 with 36 patients recruited.
The trials are on track to report full safety and immunological
data as well as final tumour response statistics in the second
half of 2005. Patient survival, which can be compared to historical
controls, will be reported once the median survival has been
reached in the two trials. This is anticipated in early 2006.
Commenting on the
ASCO presentation of Phase II results for TroVax, Oxford BioMedica’s
Chief Scientific Officer, Dr Sue Kingsman, said: "We
are very pleased with the progress of TroVax in clinical trials
and look forward to presenting new data at ASCO".
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Notes
| 1. |
Oxford
BioMedica |
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Oxford BioMedica (LSE: OXB) is a biopharmaceutical
company specialising in the development
of novel gene-based therapeutics with a
focus on the areas of oncology and neurotherapy.
The Company was established in 1995 as a
spin out from Oxford University, and is
listed on the London Stock Exchange.
Oxford
BioMedica has core expertise in gene delivery,
as well as in-house clinical, regulatory
and manufacturing know-how. In oncology,
the pipeline includes an immunotherapy and
a gene therapy in multiple Phase II trials,
and a preclinical targeted antibody therapy
in collaboration with Wyeth. In neurotherapy,
the Company’s lead product is a gene
therapy for Parkinson’s disease, which
is expected to enter clinical trials in
early 2006, and four further preclinical
candidates. The Company is underpinned by
over 80 patent families, which represent
one of the broadest patent estates in the
field.
The
Company has a staff of approximately 65
split between its main facilities in Oxford
and its wholly owned subsidiary, BioMedica
Inc, in San Diego, California. Oxford BioMedica
has corporate collaborations with Wyeth,
Intervet, Amersham, Viragen, MolMed and
Kiadis; and has licensed technology to a
number of companies including Merck &
Co and Biogen Idec.
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| 2. |
TroVax®
cancer immunotherapy |
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TroVax is Oxford BioMedica’s leading
cancer immunotherapy product. It is designed
specifically to stimulate an anti-cancer
immune response and has potential application
in most solid tumour types. TroVax targets
the tumour antigen 5T4, which is broadly
distributed throughout a wide range of solid
tumours. The presence of 5T4 is correlated
with poor prognosis. The product consists
of a poxvirus (MVA) gene transfer system,
which delivers the gene for 5T4 and stimulates
a patient’s body to produce an anti-5T4
immune response. This immune response destroys
tumour cells carrying the 5T4 protein.
In
Phase I/II trials in late stage colorectal
cancer patients, TroVax was safe and well
tolerated; patients mounted an anti-5T4
immune response; and the immune response
correlated, with high significance, to time
to disease progression, which translated
into a correlation with improved overall
survival.
Four
Phase II trials are underway. Positive initial
data from trials investigating TroVax in
colorectal cancer in combination with first
line standard of care treatment and as a
(neo) adjuvant to surgery were released
in March 2005. The primary endpoints of
safety and immunological responses were
achieved. In the two trials of TroVax alongside
chemotherapy, the secondary endpoint of
tumour response rate exceeded expectation.
A
further Phase II trial is ongoing in renal
cell carcinoma, and the US National Cancer
Institute, through the Southwest Oncology
Group, is planning a Phase II trial in breast
cancer.
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| 3. |
ASCO |
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The American Society of Clinical Oncology
is the world's leading professional organisation
representing physicians who treat people
with cancer. ASCO's members set the standard
for patient care worldwide and lead the
fight for more effective cancer treatments,
increased funding for clinical and translational
research, and, ultimately, cures for the
many different cancers that strike millions
of people around the world every year.
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further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel: +44 (0)1865 783 000 |
| City/Financial
Enquiries
Lisa
Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
Tel: +44 (0)20 7466 5000
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Scientific/Trade
Press Enquiries
Sue
Charles, Katja
Stout, Ashley
Lilly
College Hill - Life Sciences |
Tel:
+44 (0)20 7886 8150 |
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