Agreement with FDA
Oxford Biomedica PLC
12 May 2006
For Immediate Release 12 MAY 2006
OXFORD BIOMEDICA SECURES AGREEMENT WITH FDA ON SPECIAL PROTOCOL ASSESSMENT FOR
PHASE III TRIAL OF TROVAX IN RENAL CANCER
Oxford, UK - 12 May 2006: 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(R) (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.'
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan
Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 7886 8150
Katja Stout/ Gemma Bradley
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 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 two candidates in multiple Phase II trials, and a preclinical targeted
antibody therapy in collaboration with Wyeth. A Phase III trial in renal cancer
with TroVax, the lead cancer immunotherapy candidate, is expected to start in
the second half of 2006. In neurotherapy, the Company's lead product is a gene
therapy for Parkinson's disease, which is expected to enter clinical development
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.
Further information is available at www.oxfordbiomedica.co.uk
2. TroVax(R)
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(R) and Sutent(R), 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.
4. Special Protocol Assessment (SPA)
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
This information is provided by RNS
The company news service from the London Stock Exchange
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