Phase II Date @ AAI Meeting
Oxford Biomedica PLC
17 May 2007
For Immediate Release 17 MAY 2007
OXFORD BIOMEDICA ANNOUNCES THAT PHASE II RESULTS WITH HI-8(R) MEL IN MELANOMA
WILL BE PRESENTED AT AMERICAN ASSOCIATION OF IMMUNOLOGISTS MEETING
Oxford, UK: 17 May 2007: Oxford BioMedica (LSE: OXB), the leading gene therapy
company, today announces that scientists from its wholly owned subsidiary, Oxxon
Therapeutics, and its clinical collaborators will present results from a Phase
II trial of Hi-8 MEL in melanoma at the American Association of Immunologists
(AAI) Annual Meeting, to be held on 18-22 May in Miami, Florida. The abstract
has been selected for both an oral and a poster presentation.
The presentation will include updated data from the completed Phase II trial of
Hi-8 MEL in 41 patients with Stage III/IV melanoma, which was conducted at
multiple sites in the UK and Germany. The trial was designed to evaluate the
immune and clinical responses elicited by the prime-boost immunotherapeutic
vaccine, Hi-8 MEL. The product consists of a recombinant DNA vaccine and
modified vaccinia virus Ankara (MVA), both of which have been engineered to
contain DNA that encodes a string of seven cytotoxic T-cell epitopes from five
melanoma antigens.
The presentation will include further follow-up of a patient that exhibited both
a sustained partial clinical response (tumour shrinkage) and also a strong
antigen-specific immune response following treatment. In addition, the
presentation will highlight previously reported data on immunogenicity and
clinical benefit. The product was highly immunogenic with 91% of patients that
received the optimal dose showing an antigen-specific immune response. In terms
of clinical benefit, eight patients (20%) showed disease control, including the
patient with a partial response and an additional seven patients with periods of
stable disease. The median survival for immune responders was 100 weeks versus
37 weeks for non-responders (p<0.001). Details of the presentations are as
follows:
Title: Induction of antigen-specific CD8+ T cells in melanoma patients using a
prime-boost therapeutic vaccine (Abstract #48.18).
Poster Presentation
Session: Tumour-Associated Antigens/Cancer Vaccines Immunotherapy.
Date and location: Saturday, 19 May 2007, 7:30 AM-6:00 PM, Miami Beach
Convention Center, Exhibit Hall B.
Oral Presentation
Session: Tumour-Associated Antigens and Cancer Vaccines.
Date and Location: Sunday, 20 May 2007, 11.45 AM-12.15 PM, Miami Beach
Convention Center, Room A101/102
The abstract may be accessed online at http://www.immunology2007.org.
-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 7268 3002
Gemma Price/ Holly Griffiths/ Katja Stout
Northbank Communications
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development and commercialisation of novel therapeutic vaccines and gene-based
therapies 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.
The Company has a platform of gene delivery technologies, which are based on
highly engineered viral systems. Oxford BioMedica also has in-house clinical,
regulatory and manufacturing know-how. In oncology, the lead product candidate
is TroVax(R), an immunotherapy for multiple solid cancers, which is licensed to
Sanofi-Aventis for global development and commercialisation. A Phase III trial
of TroVax in renal cancer is ongoing and Sanofi-Aventis is implementing a
development plan for colorectal cancer. Oxford BioMedica's oncology pipeline
includes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, which
has completed two clinical trials. In neurotherapy, the Company's lead product,
ProSavin(R), is expected to enter clinical development for Parkinson's disease
in 2007. The neurotherapy pipeline also includes preclinical gene-based
therapeutics for vision loss, motor neuron disease and nerve repair. In
addition, the Company has a platform technology for therapeutic vaccines for
infectious diseases.
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 75 split between its main facilities in Oxford and its wholly
owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners
include Sanofi-Aventis for TroVax and Wyeth for a targeted antibody therapy. The
Company also has collaborations with Intervet, Sigma-Aldrich, Viragen, MolMed
and Virxsys. Technology licensees include Merck & Co, Biogen Idec,
GlaxoSmithKline and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
2. Hi-8(R) MEL
Hi-8 MEL is Oxford BioMedica's therapeutic vaccine for metastatic melanoma. The
product consists of two recombinant vectors, a plasmid DNA and a non-replicating
Modified Vaccinia Ankara (MVA) virus. Both vectors encode the Mel3 polyepitope
string derived from five different melanoma-associated antigens. Administration
of the two recombinant vectors in a heterologous prime-boost format is designed
to induce broad melanoma-specific CD8+ T-cell responses. All clinical endpoints
have been achieved in two completed clinical trials, which included a Phase II
dose-selection study in 41 patients with non-resectable, Stage III/IV melanoma.
Melanoma comprises just 5% of all skin cancers but it is the most deadly. It is
the seventh most common cancer in the USA. Median survival is less than one year
for Stage IV disease and less than five years for Stage III disease. The total
treatment market for melanoma is forecast to be in excess of US$775 million by
2010 (Datamonitor).
This information is provided by RNS
The company news service from the London Stock Exchange
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