Oxford Biomedica Announces That Phase II Results with Hi-8 Mel in Melanoma Will Be Presented at American Association of Immunologists Meeting
OXFORD, England, 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).
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.
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
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive
Tel: +44 (0)1865 783 000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications
Tel: +44 (0)20 7466 5000
Scientific/Trade Press Enquiries:
Gemma Price/ Holly Griffiths/ Katja Stout
Tel: +44 (0)20 7268 3002
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.
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).
Posted: May 2007