Trovax Clarification
Oxford Biomedica PLC
24 October 2005
FOR IMMEDIATE RELEASE 24 OCTOBER 2005
OXFORD BIOMEDICA CLARIFIES TROVAX(R) STRATEGY
Oxford, UK: 24 October 2005 - 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(R); 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-
For further information, please contact:
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 Tel: +44 (0)20 7466 5000
Communications
Scientific/Trade Press Enquiries:
Sue Charles/ Katja Stout/ Ashley Lilly Tel: +44 (0)20 7886 8150
Northbank Communications
Notes to editors
1. Oxford BioMedica
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,
Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to a
number of companies including Merck & Co, Biogen Idec and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
2. TroVax(R) cancer immunotherapy
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 over 70 patients treated, TroVax has been safe and well tolerated, and
induced a strong anti-5T4 immune response. In the completed Phase I/II trials,
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 and data to date have been encouraging.
Further trials including Phase III trials are planned.
This information is provided by RNS
The company news service from the London Stock Exchange