Trovax & Proposed Fundraising
Oxford Biomedica PLC
02 November 2005
FOR IMMEDIATE RELEASE 2 NOVEMBER 2005
OXFORD BIOMEDICA ANNOUNCES PROGRESS WITH REGISTRATION PLAN AND PARTNERSHIP
DISCUSSIONS FOR TROVAX, AND PROPOSED INSTITUTIONAL PLACING AND OPEN OFFER FOR
£20-£30 MILLION ALONGSIDE $5 MILLION INVESTMENT BY SIGMA-ALDRICH
Oxford, UK: 2 November 2005 - Oxford BioMedica (LSE: OXB), the leading gene
therapy company, announces progress with its registration plan and details of a
Phase III trial with its lead cancer immunotherapy, TroVax, in renal cell
carcinoma; provides further guidance on the status of partnership discussions
for TroVax; and provides clarification of press speculation regarding a proposed
fund raising.
The Company plans to initiate a Phase III trial with TroVax in renal cell
carcinoma (RCC) during 2006. TroVax has the potential to be used for the
treatment of most solid tumours, targeting a market that currently exceeds $15
billion. The relatively rapid progress of RCC in the majority of patients
creates an opportunity for a definitive study to demonstrate efficacy with
TroVax within a relatively short time frame. Thus, RCC provides the fastest
route to registration for TroVax. On 25 October 2005, Oxford BioMedica outlined
to the FDA its Phase III trial proposal in RCC. Following a positive discussion,
the FDA encouraged the Company to request a Special Protocol Assessment (SPA) of
the trial. An SPA enables Oxford BioMedica and the FDA to reach written
agreement on the design and size of the study necessary to achieve approval of
TroVax as a treatment for this cancer type.
TroVax, which has already been the subject of a sponsored trial by Cancer
Research UK and a planned trial by the US National Cancer Institute, is being
discussed with potential commercial partners. These prospective partners include
multinational companies with leading oncology franchises in the US, Europe and
Japan. The quality of the recent Phase II data and the Phase III trial plan in
RCC has been critical in advancing current discussions. The Company has
commenced commercial negotiations, and it remains the Company's intention to
secure a partner for TroVax.
The Company's financial position remains strong. The Company reported cash and
short term investments at 30 June 2005 of £18.6 million and a net cash outflow
from operations for the first half of 2005 of £4.3 million. The Company is
meeting with institutional investors with a view to strengthening its financial
position by raising an additional £20 million to £30 million. In addition,
Sigma-Aldrich, who entered a strategic alliance with Oxford BioMedica in October
2005 for the commercialisation of the LentiVector technology, has committed to
an equity investment of $5 million. The Directors believe that raising new funds
to commence the Phase III trial will maximise value from a commercial
partnership, as it allows the Company to complete its negotiations from a
position of greater financial strength. The Company will make a further
announcement on the fund raising in due course.
Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: 'The quality
of our reported Phase II data with TroVax justify a rapid move to Phase III
development, thereby strengthening the value of the programme. We are delighted
with the FDA's response to our Phase III trial plan in renal cell carcinoma. The
proposed fund raising is a strategic move that enables the Company to start the
Phase III trial and maximise the value of a corporate partnership for TroVax.'
-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 85 patients treated to date, 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.
Data from four ongoing Phase II trials have been encouraging and confirmed the
relationship between the anti-cancer immune response stimulated by TroVax and
tumour responses in patients. Further trials including Phase III trials are
planned.
3. Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common form of kidney cancer and the
tenth most common cancer in the US. More than 150,000 people are newly diagnosed
with RCC worldwide each year. Prognosis is very poor. If RCC has metastasised to
other organs at the time of first diagnosis, the five-year survival rate is less
than five per cent. In the United States and Europe, RCC accounts for more than
33,000 deaths each year.
To date, neither radiation, chemotherapy, nor hormonal therapy prolongs the
survival of metastatic RCC patients. Commonly used treatments for patients with
metastatic RCC include cytokines such as interferon-alpha, which has limited
efficacy, and interleukin-2, which is associated with severe side effects. About
40 per cent of patients with RCC develop metastases after surgery.
Analyses of sample tissues from patients with RCC have shown that the 5T4 tumour
antigen is present at high levels on approximately 90 per cent of tumours.
Hence, RCC is a logical target for a 5T4-targeted immunotherapeutic. The number
of patients with metastatic RCC means that TroVax is likely to qualify for
Orphan Drug designation in this indication, which confers various benefits in
development and commercialisation. In addition, TroVax may also receive Fast
Track designation, which is designed to expedite the review process of drug
candidates that address life threatening diseases where there is an unmet
medical need for new therapeutic approaches. With Fast Track designation, there
is the opportunity for more frequent interactions with the FDA and the
possibility of a Priority Review, which could shorten the standard review
period.
This information is provided by RNS
The company news service from the London Stock Exchange