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2006/OB/09
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OXFORD BIOMEDICA SECURES AGREEMENT WITH
FDA ON SPECIAL PROTOCOL ASSESSMENT FOR PHASE III TRIAL OF
TROVAX IN RENAL CANCER
Oxford
BioMedica (LSE: OXB), the leading gene therapy company,
announced today that it has received a Special Protocol
Assessment (SPA) agreement from the US Food and Drug Administration
(FDA) for a Phase III trial of TroVax in renal cell carcinoma.
The written agreement from the FDA specifies the design,
conduct, analysis and endpoints of the trial, which, if
successful, will support an efficacy claim in a regulatory
submission for product registration. The SPA was received
at the end of the FDA’s first review period following
Oxford BioMedica’s application in March 2006. Oxford
BioMedica plans to start the trial in the second half
of 2006.
The Phase III trial, referred to as TRIST
(TroVax Renal Immunotherapy Survival Trial), will evaluate
whether TroVax
immunotherapy, added to first line standard of care therapy,
prolongs the survival of patients with locally advanced
or metastatic clear cell renal adenocarcinoma. The trial
will be a randomised, placebo-controlled, two-arm study
of TroVax in combination with standard of care versus placebo
with standard of care. Standard of care will be interleukin-2,
interferon-alpha or Sutent® (sunitinib). Study treatment
will be stratified between the standard of care options
to ensure that the allocation of TroVax and placebo is rigorously
balanced. Recruitment will be approximately 700 patients
in about 120 centres in the USA, European Union and Eastern
Europe. The primary endpoint will be survival improvement
and secondary endpoints will include progression free survival,
tumour response rates and quality of life scores. The protocol
includes the appointment of a Safety and Efficacy Monitoring
Board (SEMB) to assess the safety and potential efficacy
of the drug combinations at various time points during the
trial.
Oxford BioMedica
is also discussing the TRIST trial with regulatory authorities
in Europe. In addition, the Company
plans to seek ‘orphan drug’ designation for
TroVax in both the USA and Europe for renal cell carcinoma.
The granting of orphan drug status would provide Oxford
BioMedica and any prospective commercial partner with
various benefits in terms of regulatory exclusivity, assistance
with clinical development and a waiver of filing fees.
Oxford BioMedica’s Chief Medical Officer, Dr Mike
McDonald, said: “We are delighted to have secured
the SPA within such a short time period. We have worked
closely with the FDA on the design of the TRIST study
and they have been extremely supportive. We look forward
to starting this pivotal trial of TroVax in a cancer setting
where there are few treatment options and there is a need
for new approaches that are both safe and effective.”
Commenting
on the SPA, Oxford BioMedica’s Chief Executive,
Professor Alan Kingsman, said: “This is a
significant milestone for the Company. It represents
the successful
achievement of the first of our major goals for 2006.”
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| Notes
| 1. |
Oxford
BioMedica plc |
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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, Virxsys and Kiadis; and has licensed
technology to a number of companies including
Merck & Co, Biogen Idec and Pfizer.
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| 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
100 patients have now been treated with
TroVax in six clinical trials (collectively
over 400 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. |
| 3. |
Renal
Cell Carcinoma |
| |
Renal
cell carcinoma (RCC) is the most common
form of kidney cancer in the USA.
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
5%. In the USA 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
at high dose levels. Two new drugs have
recently received US approval for the treatment
of metastatic RCC, Nexavar® and Sutent®,
although there are no published data showing
that they offer a survival benefit.
There are several reasons for considering
that a cancer vaccine such as TroVax might
be highly appropriate for this patient
group. There is circumstantial evidence
that immune responses may be important
in dictating the outcome for RCC patients
and a vaccine could potentiate this immune
response. TroVax, in particular, may be
the vaccine of choice since the expression
of 5T4, the antigenic component of TroVax,
is more prevalent in RCC than any other
solid cancer analysed by Oxford BioMedica.
5T4 is present at high levels on a high
proportion of cells in approximately 90%
of tumours. Treatments for RCC generated
sales of $600 million in 2004 according
to Datamonitor.
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| 4. |
Special
Protocol Assessment (SPA) |
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The
FDA’s SPA process was implemented
under the Prescription Drug User Fee
Act (PDUFA) in November 1997. Under the
SPA process, the FDA assesses the protocol
design, conduct and data analyses of
a trial. Once the protocol is agreed
in writing, then the assessment is binding
on the review division of the FDA as
long as the protocol is followed, unless
substantial scientific issues essential
to determining the safety or efficacy
of the drug are identified later. Clinical
protocols for Phase III trials that are
assessed under the SPA process can form
the primary basis of an efficacy claim
in a marketing application submitted
to the FDA. Further information on the
SPA process is available at www.fda.gov |
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