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2005/OB/36
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OXFORD
BIOMEDICA CLARIFIES TROVAX® STRATEGY
Oxford
BioMedica (LSE: OXB), the leading gene therapy company, provides
clarification of its strategy for its lead cancer immunotherapy,
TroVax.
Over the
past week the Company has made announcements concerning its
lead product, TroVax; its second anti-cancer clinical product,
MetXia®; its anti-cancer antibody-targeted
therapy in preclinical development with Wyeth; a strategic
commercial alliance with Sigma-Aldrich; and, most recently,
a further licence agreement for its LentiVector technology.
The Company
is delighted that it has been able to deliver such positive
news to the market and its shareholders. However, it has received
a number of enquiries from shareholders over the course of
last week suggesting that there may be some confusion in the
market as to the Company’s strategy regarding TroVax.
It therefore wishes to clarify that:-
- in
the announcement of encouraging TroVax Phase II data, made
on 17 October 2005, the Company stated that it intended
to secure a development partner for TroVax within the next
12 months. This is entirely consistent with the previous
published guidance that the Company intends to secure such
a deal in 2005-06. This guidance is commercially strategic
in that it keeps the Company’s options open during
discussion with potential partners. The statement made last
week does not represent a change in the Company’s
plans;
- based
on current ongoing discussions with potential partners,
the Company does not envisage any requirement to modify
TroVax in order to increase the number of patients that
mount anti-cancer immune responses. In comparison with published
data for other cancer vaccines in clinical trials, TroVax
is highly immunogenic. There are currently no plans to modify
the product and all discussions with potential partners
are based on taking TroVax forward to product registration
in its current form; and
- the
Company has spent the last nine months considering the next
stage of development of TroVax in various cancer types through
detailed consultation with the regulators (FDA), leading
international clinicians and potential partners. Although
the outcome of this process is yet to be finalised, the
overwhelming body of opinion is that TroVax is ready for
Phase III development and the nature of such trials is a
key point of discussion with potential partners. The consensus
view is that a Phase IIb study is not required before proceeding
to Phase III and this is consistent with the Company maintaining
its expectation of product registration of TroVax in 2009.
-
ends -
Return to the News
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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
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 70
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, Viragen, MolMed and Kiadis; and
has licensed technology to a number of companies
including Merck & Co, Biogen Idec and
Pfizer.
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| 2. |
LentiVector
technology |
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Oxford
BioMedica’s LentiVector gene delivery
technology, based on lentiviruses, is arguably
the most potent system currently available
for treating a range of diseases, particularly
those of the central nervous system. Oxford
BioMedica has shown that its lentiviral
vectors are able to deliver genes with high
efficiency to a variety of both dividing
and non-dividing cells, including neurons
in the brain.
Oxford
BioMedica has three issued US patents and
a European patent for its LentiVector technology.
These include broad composition of matter
claims and methods of production claims
for lentiviral vector gene delivery systems
of both human and non-human origin. The
patents also cover derivatives of lentiviral
vector systems that, unlike many versions
of lentiviral vectors, have real clinical
utility because of their safety.
The
Company has established a neurotherapy pipeline
of product candidates based on its LentiVector
technology, which includes ProSavin®
for Parkinson’s disease, RetinoStat®
for retinopathy, MoNudin®
for motor neuron disease, SMN1-G for spinal
muscular atrophy and Innurex®
for nerve repair.
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For
further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive
Peter
Nolan, SVP Commercial Development |
Tel: +44 (0)1865 783 000 |
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City/Financial
Enquiries
Lisa
Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
Tel: +44 (0)20 7466 5000 |
Scientific/Trade
Press Enquiries
Sue
Charles, Katja
Stout
College Hill - Life Sciences |
Tel:
+44 (0)20 7886 8150 |
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