Final Phase II Results
Oxford Biomedica PLC
17 October 2005
FOR IMMEDIATE RELEASE 17 OCTOBER 2005
OXFORD BIOMEDICA PRESENTS ENCOURAGING FINAL PHASE II RESULTS WITH TROVAX(R) IN
COLORECTAL CANCER AT THE INTERNATIONAL COLORECTAL CANCER CONGRESS
- Confirms safety, immunogenicity and clinical benefit -
Oxford, UK: 17 October 2005 - Oxford BioMedica (LSE: OXB), the leading gene
therapy company, today announced that further encouraging data were presented
from the Phase II trials of TroVax, its cancer immunotherapy, in metastatic
colorectal cancer (CRC) at the Fourth International Colorectal Cancer Congress
in Aventura, Florida, USA, on Saturday 15 October 2005.
The presentation included a complete and final analysis of safety and immunology
from the two Phase II trials with TroVax in first line treatment of CRC
alongside irinotecan-based (IFL) and oxaliplatin-based (FOLFOX) chemotherapy.
The presentation also included additional information on tumour responses based
on CT scan data. The results confirm the preliminary conclusions that were
presented at the American Society of Clinical Oncology (ASCO) meeting on 15 May
2005. The conclusions are that the primary endpoints of safety and
immunogenicity were achieved and that the secondary endpoint of clinical benefit
has exceeded the Company's expectation based on tumour responses.
Enrolment in the trials was completed in September 2004 with 36 patients
recruited. A key objective of these studies was to confirm that the anti-tumour
immune response observed in the Phase I/II trial with TroVax as a single agent
was preserved in patients receiving chemotherapy. Analysis, therefore, focused
on 'per protocol' patients who received all prescribed cycles of chemotherapy
and six immunisations of TroVax. As expected, about one third of patients did
not complete the chemotherapy regimen and, therefore, dropped out of the trials
for reasons unrelated to TroVax. Across both trials, there were 23 'per
protocol' patients.
TroVax was safe and well tolerated in all patients with no serious adverse
events being associated with TroVax treatment. All 23 patients showed an
anti-tumour immune response, elicited by TroVax, against the 5T4 tumour antigen.
Compared with the Phase I/II study, these Phase II chemotherapy protocols do not
appear to impair the ability of TroVax to stimulate an anti-tumour response and
may, in fact, enhance the response at particular time points during the therapy.
The human immune system is made up of multiple interacting elements including
the humoral (antibody) and cell-mediated (T cell) arms. In these Phase II
trials, Oxford BioMedica performed a comprehensive analysis of both arms of the
immune response as detailed below:
• Antibody response: Over 90% of patients mounted anti-5T4 antibody
responses, which were of higher magnitude and longer duration than those
seen in the Phase I/II trial that evaluated TroVax in the post chemotherapy
CRC setting.
• T cell response: 100% of patients showed T cell responses. 70% of these
have been confirmed as cytotoxic T cell (CD8) responses, which, in some
patients, were at levels comparable to those observed in response to
infectious disease pathogens. The frequency and levels of CD8 responses with
TroVax are at the top end of the range in the field of cancer immunotherapy.
This is of particular significance because the industry as a whole,
including several potential partners for the TroVax programme, believes that
it is these CD8 cells that are the main effectors of anti-tumour activity.
The secondary endpoint of clinical benefit includes analysis of tumour responses
and overall survival. The number of tumour responses in the trials has been
encouraging so far (NB: the data are unaudited and subject to third party
review). Across both trials, 91% of patients have shown disease control, which
comprises complete responses, partial responses and stable disease according to
industry standard RECIST criteria. The detailed tumour response figures are as
follows:
• TroVax plus IFL trial: Twelve patients completed the chemotherapy and
TroVax regimen. Tumour response data are based on CT scans at 26 weeks.
There was one complete response, six partial responses and four patients
with stable disease.
• TroVax plus FOLFOX trial: Eleven patients completed the chemotherapy and
TroVax regimen. Tumour response data are based on CT scans at 14 weeks.
There were three complete response, five partial responses and two patients
with stable disease. In this trial, an independent statistician identified a
statistical relationship (p < 0.02) between the anti-5T4 immune response and
tumour responses.
Although the trials were small, in terms of patient numbers, and were not
designed with control arms, the levels of clinical benefit are encouraging when
compared to published trial data for chemotherapy alone in similar settings. For
both trials, the final audited tumour response figures and patient survival will
be reported in 2006. The trials have not been running long enough to comment on
survival at this time.
The International Colorectal Cancer Congress, which was held in Aventura,
Florida, USA, on 14-16 October 2005, is designed as a learning opportunity for
medical, surgical, and radiation oncologists as well as gastroenterologists and
internal medicine and primary care physicians. The presentation of the Phase II
results with TroVax was given by Richard Harrop, Director of Clinical Immunology
at Oxford BioMedica, during a session titled 'New Agents of Interest' on
Saturday, 15 October 2005. The presentation can be accessed on line at
www.oxfordbiomedica.co.uk. The title of the presentation is 'Vaccination with
TroVax in Combination with Chemotherapy: A Productive Partnership'
The Phase II results are also being presented at another conference called
Colorectal Cancer: Molecular Pathways and Therapies on 19-23 October in Dana
Point, California, USA. This meeting is being organised by the American
Association for Cancer Research (AACR). Oxford BioMedica will make a poster
presentation on Friday, 21 October 2005. Further information is available at
www.aacr.org/page4553.aspx
Commenting on the TroVax Phase II results, Oxford BioMedica's Chief Medical
Officer, Dr Mike McDonald, said: 'We are very pleased that the final data from
the TroVax Phase II trials have confirmed our preliminary conclusions that the
product is both safe and immunogenic. The tumour response rates are similarly
encouraging. As more data emerge from our Phase II trials, we are increasingly
confident that TroVax will have a role to play in the treatment of a wide range
of solid tumours'.
Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: 'One of our
main goals within the TroVax programme is to secure a development partner within
the next 12 months. The promising results reported recently from our Phase II
trials in both colorectal and renal cancer have been key in our ongoing
discussions with prospective partners for TroVax'.
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications Tel: +44 (0)20 7466 5000
Scientific/Trade Press Enquiries:
Sue Charles/ Katja Stout/ Ashley Lilly
Northbank Communications Tel: +44 (0)20 7886 8150
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 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, Viragen,
MolMed 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) cancer immunotherapy
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 protein.
In over 70 patients treated, TroVax has been safe and well tolerated, and
induced a strong anti-5T4 immune response. In the completed Phase I/II trials,
the immune response correlated, with high significance, to time to disease
progression, which translated into a correlation with improved overall survival.
Four Phase II trials are underway and data to date have been encouraging.
Further trials including Phase III trials are planned.
3. International Colorectal Cancer Congress
The Fourth International Colorectal Cancer Congress is an educational and
scientific symposium designed to provide participants with leading-edge updates
in the comprehensive management of patients with colorectal cancer, including
the integration of targeted agents, as well as recent developments in
chemotherapy, radiation, and surgical treatments. In addition, the congress will
delve into the biology, screening, diagnosis, and prevention of colorectal
cancer. Further information is available at www.cancerconferences.com/
conferences/gastro/ccc/
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