SWOG in phase 2 Trovax trial
Oxford Biomedica PLC
05 September 2006
FOR IMMEDIATE RELEASE 5 SEPTEMBER 2006
SOUTHWEST ONCOLOGY GROUP TO START PHASE II TRIAL OF OXFORD
BIOMEDICA'S TROVAX IN BREAST CANCER
- Regulatory clearance for start of patient recruitment in 120-patient Phase II
trial of TroVax in patients with late-stage breast cancer -
Oxford, UK - 5 September 2006: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announces that the Southwest Oncology Group (SWOG), a US
clinical trials cooperative group, has received regulatory clearance to commence
a Phase II trial of Oxford BioMedica's cancer immunotherapy, TroVax, in patients
with late-stage breast cancer. The US National Cancer Institute is sponsoring
the trial and is responsible for the principal costs.
In June 2006, SWOG submitted the trial plan to the US Food and Drug
Administration and no issues were raised by the FDA. In August 2006, the study
was submitted to the US Recombinant DNA Advisory Committee and was similarly
accepted, which means that the trial can now commence.
The targeted population for this study will be late-stage (Stage III and IV)
breast cancer patients who have received standard therapy and have either
minimal residual disease or no evidence of disease. These patients are at high
risk of relapse. The current published literature indicates a median
progression-free survival of 18 to 22 months for this patient group.
Approximately 120 patients will be enrolled in this open-label trial. Patients
will receive monthly injections of TroVax for three months, followed by booster
immunisations at six, nine and 12 months.
Key endpoints will include immunological response rates to the 5T4 tumour
antigen and progression-free survival versus historical controls. SWOG, which is
responsible for all aspects of the trial, could commence patient enrolment
before the end of 2006 in centres in the USA. The trial is expected to complete
in approximately two to three years. Should this trial prove successful, SWOG
may conduct a Phase III trial in the same setting.
This is the first trial of Oxford BioMedica's cancer immunotherapy, TroVax, in
patients with breast cancer. The 5T4 tumour antigen, which is targeted by
TroVax, is broadly distributed across most solid tumours. Previous studies have
shown that high levels of the 5T4 tumour antigen are present on over 80% of
breast cancer cases. To date, approximately 150 patients have been treated with
TroVax in ten clinical trials in colorectal, renal and prostate cancer. Oxford
BioMedica plans to start a Phase III trial (TRIST) in renal cell carcinoma in
the second half of 2006.
Commenting on the progress of SWOG towards starting the Phase II trial in breast
cancer, Oxford BioMedica's Chief Medical Officer, Dr Mike McDonald, said: 'We
are delighted that the Southwest Oncology Group is committed to evaluate TroVax
as a potential treatment for breast cancer. Given what we know of the product's
safety profile and the anti-cancer immune response that it stimulates, we are
hopeful that TroVax can delay relapse of disease in this population of
advanced-stage patients.'
-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 3008 7555
Gemma Bradley/ Susan Yu/ Katja Stout
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.
Approximately 150 patients have now been treated with TroVax in ten clinical
trials (collectively approximately 450 doses). The Company is targeting
colorectal cancer and renal cell carcinoma as lead indications for the
development of TroVax. Renal cell carcinoma is an indication where TroVax might
achieve a rapid route to product registration. Oxford BioMedica plans to start a
Phase III trial (TRIST - TroVax Renal Immunotherapy Survival Trial) in 700
patients with advanced renal cell carcinoma in the second half of 2006. The
TRIST study received a Special Protocol Assessment from the US Food and Drug
Administration in May 2006. A Phase II trial in prostate cancer is ongoing and a
trial in breast cancer is due to start under the auspices of the US Southwest
Oncology Group.
3. Breast Cancer
Breast cancer is the leading cause of cancer-related death among women in the
USA and Europe. It is second only to lung cancer. According to the American
Cancer Society, 212,920 women in the USA will be diagnosed with breast cancer in
2006, and 40,970 will die from the disease. Excluding skin cancer, breast cancer
is the most common form of cancer among women. The numbers are even higher in
the European Union, with an estimated 270,000 new cases of the disease diagnosed
annually and 88,000 deaths. While today in the USA, the 5-year relative survival
rate for localised breast cancer is 98%, the figure for patients with distant
metastases is 26%.
Analyses of sample tissues from patients with breast cancer have shown that the
5T4 tumour antigen is present at high levels on over 80% of breast tumours.
Hence, breast cancer is a logical target for a 5T4-targeted immunotherapeutic.
4. Southwest Oncology Group
The Southwest Oncology Group (SWOG) is one of the largest cancer clinical trials
cooperative research groups in the USA. The Group is a network of more than
5,000 physician-researchers located at nearly 550 institutions. In addition to
their regular medical practices, Group investigators work together on clinical
trials funded by the US National Cancer Institute (NCI), part of the National
Institutes of Health, to prevent and treat cancer in adults. Among the Group's
institutions are 17 of the NCI's 61 designated cancer centres. The Group enrols
nearly 7,200 patients each year and has about 120 clinical trials underway at
any given time. SWOG has its headquarters at the University of Michigan in Ann
Arbor, Michigan.
This information is provided by RNS
The company news service from the London Stock Exchange
Latest directors dealings
- 1 day ago Savannah Energy
- 1 day ago Buccaneer Energy PLC
- 1 day ago Savannah Energy
- 1 day ago Carclo
- 1 day ago Schroder Japan Growth Fund