Oxford BioMedica Presents Updated TroVaxR Phase I/II and II Results at
ASCO Annual Meeting
- Survival and Immunological Data in Colorectal and Renal Cancer -
Oxford, UK – 1 June 2009: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, today announces updated results from open-label Phase I/II
and II trials of TroVax in metastatic colorectal cancer and metastatic renal
cancer. TroVax is Oxford BioMedica’s therapeutic cancer vaccine that targets
the 5T4 tumour antigen. Two cross-trial analyses were presented at the 45th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando,
Florida.
In all trials, TroVax was well tolerated with no serious adverse events
attributed to vaccination. The most frequent TroVax-related side effect was
low-grade transient irritation at the injection site.
Phase I/II and II Cross-Trial Analysis in Colorectal Cancer
The presentation described a cross-trial analysis of one Phase I/II and three
Phase II trials in patients with metastatic colorectal cancer. In the four
trials, TroVax was administered alone (one trial); as adjuvant/neo-adjuvant to
surgery for resectable liver metastases (one trial); or in combination with
chemotherapy (FOLFOX or FOLFIRI; two trials).
Survival data were available for 73 patients, who received a median of five
TroVax vaccinations (range one to six vaccinations). Of 59 immunologically
evaluable patients tested for antibody responses post-vaccination, 52 (88%)
and 56 (95%) showed positive responses for the 5T4 tumour antigen and the
vector system, Modified Vaccinia Ankara (MVA), respectively. Exploratory
analyses demonstrated significant associations between immune responses and
overall survival across the trials. Indeed, Cox proportional hazards modelling
(adjusting for age and gender) showed that a doubling in the 5T4-specific
antibody response after the second and third injections was independently
associated with a reduction in relative risk of death of 14% (p < 0.01) and
13% (p = 0.01) respectively. There were no correlations between the immune
response to MVA and patient survival, suggesting that the benefit associated
with the 5T4 response is not related to patients’ general health status.
Phase I/II and II Cross-Trial Analysis in Renal Cancer
The presentation described a cross-trial analysis of two Phase II trials in 53
patients with clear cell or papillary renal cancer with progressive measurable
metastases and any prior therapy. The two trials investigated TroVax with or
without interferon-alpha (28 patients) or in combination with low-dose
subcutaneous interleukin-2 (25 patients).
Of 45 immunologically evaluable patients, 40 (89%) mounted 5T4-specific
antibody responses. Two patients showed a complete response for >36 months and
two other patients had a partial response for >24 months and 12 months
respectively. Twenty patients demonstrated disease stabilisation for ≥3
months. Median progression-free survival and overall survival for all patients
was 3.6 months (range 0.8 to 29.7 months) and 13.2 months (range one to 38
months) respectively. In both trials, a significant relationship was detected
between the magnitude of the 5T4-specific antibody response and overall
survival.
Dr Stuart Naylor, Oxford BioMedica’s Chief Scientific Officer, commented on
the presentations: “These updated analyses of our trials in colorectal and
renal cancer further support the mechanistic rationale that the immune
response induced by TroVax provides potential clinical benefit. It is
interesting to note that an association between the magnitude of the antibody
response to the 5T4 tumour antigen and enhanced patient survival is detected
as early as post-second vaccination in colorectal cancer. While care must be
taken when considering results from post-hoc analyses, the detection of an
association with 5T4, but not MVA, antibody responses across multiple trials
is encouraging. We remain committed to the successful development and
commercialisation of TroVax and we are working constructively with the FDA to
define the potential development path for further trials.”
The abstracts can be accessed online at
http://www.asco.org
-Ends-
For further information, please contact:
Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Nick Woolf, Chief Business Officer
Tel: +44 (0)1865 783 000
JPMorgan Cazenove Limited:
James Mitford/ Gina Gibson
Tel: +44 (0)20 7588 2828
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Elliott
Buchanan Communications
Tel: +44 (0)20 7466 5000
Scientific/Trade Press Enquiries:
Sue Charles/ Holly Griffiths/ John McIntyre
College Hill Life Sciences
Tel: +44 (0)20 7457 2020
US Enquiries:
Thomas Fechtner
The Trout Group LLC
Tel: (646) 378 2900
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company developing
innovative gene-based medicines and therapeutic vaccines that aim to improve
the lives of patients with high unmet medical needs. The Company’s technology
platform includes a highly efficient gene delivery system (LentiVector®),
which has specific advantages for targeting diseases of the central nervous
system and the eye; and a unique tumour antigen (5T4), which is an ideal
target for anti-cancer therapy. Through in-house and collaborative research,
Oxford BioMedica has a broad pipeline. Partners include sanofi-aventis,
Sigma-Aldrich and Wyeth. Technology licensees include Biogen-Idec,
GlaxoSmithKline, Merck & Co and Pfizer. Further information is available at
www.oxfordbiomedica.co.uk
2. TroVax®
TroVax is Oxford BioMedica’s novel therapeutic cancer vaccine, which 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 Modified Vaccinia Ankara vector, 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 antigen.
