OXFORD BIOMEDICA RESPONDS TO SHARE PRICE MOVEMENT AND REPORTS BUSINESS UPDATE
Oxford, UK - 25 October 2007: Oxford BioMedica (LSE:
OXB), a leading gene therapy company, notes the movement in the share price over the last month and confirms that it is not
aware of any valid reason for the fall. However, the Company is aware of two misconceptions that are circulating in the
market.
Firstly, it has been stated that in the Phase III TRIST study,
TroVax is being evaluated in competition with standard of care. This is incorrect. TroVax will be used in addition
to standard of care. The target label for TroVax is first line therapy for renal cell carcinoma with standard of care.
The development of the anti-cancer therapy Avastin® followed a similar strategy. Avastin is generating revenue in
excess of $2 billion as a treatment that is added to standard of care for certain metastatic cancers.
Secondly, it has been stated that TroVax has failed in an ovarian cancer trial. This is incorrect. TroVax has not yet
been evaluated in ovarian cancer. All studies completed to date have met their endpoints; and TroVax has not failed in
any study or cancer type to date.
The Company continues to make good progress financially and
operationally. A business update is set out below:
Finance - Current Cash
The Company's current cash position and potential revenues from the collaboration with sanofi-aventis for TroVax
immunotherapy provide sufficient resources for the Company to reach sustained profitability, which is anticipated
in 2009. The Company's net cash position at 30 September 2007 was approximately £44 million, which is slightly higher
than the reported net cash1 position at 30 June 2007 of £42.5 million; a consequence of receiving approximately
£6 million from sanofi-aventis on achievement of the first development milestone in the TroVax collaboration.
TroVax® - Phase III Update
Patient recruitment in the Phase III TRIST trial of TroVax in renal cancer is on track. Approximately 450 patients have
now been randomised into the study. The target enrolment is 700 patients, which the Company expects to be completed in
early 2008. This supports the stated time line from both Oxford BioMedica and sanofi-aventis for final data and
potential product registration in renal cancer in 2009.
On 17 September, sanofi-aventis disclosed details of its planned
Phase III trial of TroVax in metastatic colorectal cancer. Similar to the TRIST trial, this Phase III study in
colorectal cancer will evaluate TroVax versus placebo. The trial is expected to enrol 1,300 patients. All
patients will receive standard of care (chemotherapy +/- bevacizumab, i.e. Avastin) plus either TroVax or placebo.
The trial will have a primary endpoint of overall survival and an interim analysis of progression free survival.
The trial protocol will be submitted to the regulatory authorities shortly. Patient recruitment is expected to start
in Q2 2008.
A third Phase III trial is planned by the UK clinical
trials network, QUASAR, with support from sanofi-aventis and Oxford BioMedica. This trial is in earlier stage
colorectal cancer patients and is planned to enrol approximately 3,000 patients with recruitment expected to
commence in Q2 2008.
ProSavin® - CTA Update
As reported, Oxford BioMedica submitted a Clinical Trial Application (CTA) to conduct a Phase I/II trial of ProSavin
to the French Health Products Safety Agency (AFSSAPS) in July 2007 following several scientific meetings with the
French agency. The review of the CTA is progressing. The trial will be conducted at the Henri Mondor Hospital in
Paris where the Ethics Committee has already approved the study. Subject to approval by AFSSAPS, Oxford BioMedica
expects the first patient to be treated in late 2007 or early 2008.
Professor Alan Kingsman, Chief Executive of Oxford BioMedica,
commented: "We are more confident than ever in the strength of our financial position and our development pipeline.
We are on track to achieve our stated development milestones and we look forward to reporting on some of our key
objectives in the near future. We believe the share price retreat in recent weeks does not reflect the fundamental
strength of Oxford BioMedica today."
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1. Net cash position comprises cash,
cash equivalents and current financial assets
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