Phase II Trial Trovax
Oxford Biomedica PLC
23 May 2006
For Immediate Release 23 MAY 2006
OXFORD BIOMEDICA COMMENCES PHASE II TRIAL OF TROVAX(R)
IN PROSTATE CANCER
Oxford, UK - 23 May 2006: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, announced today that a Phase II trial of TroVax in patients with
prostate cancer that is unresponsive to hormone therapy is open for recruitment.
This is the first clinical trial of TroVax in this cancer type.
The Phase II trial in prostate cancer is being conducted at the Methodist
Hospital in Houston, Texas, USA. The Principal Investigator for the trial is Dr
Robert Amato. The trial is designed to enrol 24 men with hormone-refractory
prostate cancer who have previously received chemotherapy or have refused
chemotherapy and have progressive disease. The trial is open label and will have
two arms (12 patients each) to assess the activity of TroVax alone versus TroVax
alongside an approved treatment for prostate cancer, granulocyte
macrophage-colony stimulating factor (GM-CSF).
The primary objectives of the trial are to evaluate the safety and synergies of
the combination treatment, and to assess whether GM-CSF, which is known to
increase white blood cell count and hence boost the immune system, increases the
anti-cancer immune response stimulated by TroVax. Efficacy endpoints include
objective response rate, progression-free survival, overall survival and changes
in prostate-specific antigen (PSA) level, which is a recognised marker of
disease status.
Prostate cancer is the leading cause of cancer in men. Localised radiotherapy or
surgery is potentially curative for early-stage disease although many patients
relapse and require hormone therapy. However, therapeutic options are limited
when the cancer has progressed and no longer responds to hormone therapy, which
is the setting for the Phase II trial of TroVax. Initial data from this trial
are expected in the first half of 2007. According to Datamonitor, treatments for
prostate cancer generated worldwide sales of $2.7 billion in 2004.
Commenting on the start of the Phase II trial in prostate cancer, Oxford
BioMedica's Chief Medical Officer, Dr Mike McDonald, said: 'We are delighted
that Dr Amato is supporting a Phase II trial of TroVax in prostate 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 provide a new therapeutic
option for patients with prostate cancer who have progressed despite hormone
therapy and for whom there are few available treatments.'
Dr Robert Amato, Director of the Genitourinary Oncology Center at the Methodist
Hospital said: 'TroVax could provide a significant benefit to patients with
hormone-refractory prostate cancer, particularly when administered with an
effective immunostimulant such as GM-CSF. Our team at the Methodist Hospital has
seen some intriguing clinical responses with TroVax from our trial in renal cell
carcinoma and we are delighted to expand our collaboration with Oxford BioMedica
into prostate cancer.'
Oxford BioMedica's Chief Executive Officer, Professor Alan Kingsman added: 'As
we broaden and deepen the clinical development of TroVax, the value of our lead
product candidate increases for potential partners.'
Clinical evaluation of TroVax is ongoing in renal cell carcinoma, colorectal
cancer and now prostate cancer. Oxford BioMedica plans to start a Phase III
trial in renal cell carcinoma in the second half of 2006. The Company recently
secured a Special Protocol Assessment agreement with the FDA for this Phase III
trial. An update on the clinical trials and development plan for TroVax will be
released to coincide with TroVax presentations at the American Society of
Clinical Oncology (ASCO) Annual Meeting, to be held on 2-6 June in Atlanta,
Georgia, USA.
-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. Prostate cancer
Prostate cancer is the leading cause of cancer in men. According to the American
Cancer Society, an estimated 232,090 new cases of prostate cancer were diagnosed
in the USA in 2005 and approximately 29,900 men die of this disease annually.
The five-year survival rate of men with prostate cancer is 98%, although this
falls to 34% for metastatic disease. Localised radiotherapy or surgery is
potentially curative for early-stage disease although many patients relapse and
require hormone therapy. According to Datamonitor, treatments for prostate
cancer generated worldwide sales of $2.7 billion in 2004. However, therapeutic
options are limited when the cancer has progressed and no longer responds to
hormone therapy. Early detection is important, and it is recommended that men
over the age of 50 have a prostate-specific antigen (PSA) blood test every year.
This information is provided by RNS
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