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2005/OB/37
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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
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
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."
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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, Sigma-Aldrich, 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. |
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
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.
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| 3. |
Renal
Cell Carcinoma |
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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.
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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
Katja
Stout/Hannah
Carter
College Hill - Life Sciences |
Tel:
+44 (0)20 7886 8150 |
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