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2006/OB/15
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UPDATE
AND CLARIFICATION ON TROVAX
Oxford
BioMedica (LSE:OXB), a leading gene therapy company, today
issues an update on TroVax, the Company’s leading cancer
immunotherapy product. The update provides information on
progress with clinical trial programmes and a marketing partner
deal for TroVax.
The Board
is pleased to confirm that the TroVax clinical development
plan is on track with appropriate regulatory submissions being
made and trial centres for the Phase III TRIST study being
set up in the US and Western and Eastern Europe. Other product
development programmes are also progressing according to plan.
A full update will be given with the Company’s interim
results on 5 September 2006.
A number
of shareholders have asked for information on progress towards
a TroVax deal. The Company is in active discussions with a
number of potential commercial partners for TroVax. Inevitably
those discussions are highly sensitive. All the potential
partners are substantial companies and have the capability
to support the Company’s plans for TroVax and the successful
marketing of this product.
Clarification
as regards Therion Biologics
The Company has noted some speculation in the market that
the failure of clinical trials of PANVAC-VF, developed by
the privately owned United States company, Therion Biologics,
might suggest that Phase III trials of TroVax will not be
successful.
Although
the Directors do not have access to detailed information on
the PANVAC-VF study, they wish to make the following comments:
- While
PANVAC-VF uses a similar viral delivery system to TroVax,
the active antigenic components of TroVax are completely
different to those used in PANVAC-VF. PANVAC-VF comprises
CEA and Muc-1 whereas TroVax comprises the Company’s
proprietary antigen, 5T4.
- The
PANVAC-VF Phase III study was in pancreatic cancer patients
who had already failed chemotherapy. This is a particularly
challenging target where no product has shown a survival
benefit. In the case of a vaccine the problem is that the
patients’ disease advances significantly before a
strong immune response has time to be established by the
product. The planned TroVax Phase III TRIST trial is in
advanced renal cell cancer patients who will have received
no prior therapy for their metastatic disease and who have
a median survival, with current care, of about 12 months.
As has been shown in a number of Phase I/II and Phase II
studies of TroVax, this is ample time for an immune response
to be established.
In summary, the Directors
do not believe that data from the PANVAC-VF trial have a significant
bearing on the future of TroVax.
- ends -
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| Notes
| 1. |
Oxford
BioMedica plc |
| |
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,
Virxsys and Kiadis; and has licensed technology
to a number of companies including Merck
& Co, Biogen Idec and Pfizer. |
| 2. |
TroVax®
|
|
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. TroVax has attracted external
support from Cancer Research UK and the
US National Cancer Institute. Over 120 patients
have now been treated with TroVax in eight
clinical trials (collectively over 450 doses).
The Company is targeting colorectal cancer
and renal cell carcinoma (RCC) as lead indications
for the development of TroVax. Renal cell
carcinoma is an indication where TroVax
might achieve a rapid route to product registration.
A clinical trial in prostate cancer is also
underway and a trial in breast cancer is
planned. |
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