Oxford Biomedica Regulatory News (OXB)

12 May 2005 10:24

Oxford Biomedica PLC12 May 2005 FOR IMMEDIATE RELEASE 12 MAY 2005 OXFORD BIOMEDICA TO PRESENT NEW TROVAX(R) DATA FROM PHASE II TRIALS IN COLORECTAL CANCER AT THE 2005 ASCO ANNUAL MEETING ON 15 MAY Oxford, UK: 12 May 2005 - Oxford BioMedica (LSE: OXB), the leading gene therapycompany, today announced that new data from the Phase II trials of TroVax, itscancer immunotherapy, in colorectal cancer will be presented on 15 May at the2005 American Society of Clinical Oncology (ASCO) Annual Meeting taking place inOrlando, Florida, USA, on 13-17 May 2005. Details are as follows: "An Open Label Phase II Study of MVA Expressing the Tumour Antigen 5T4 Given inConjunction with Chemotherapy: Safety and Immunogenicity Before, During andAfter Chemotherapy." (Abstract #30642) Session: Developmental Therapeutics, ImmunotherapySunday 15 May, 8:00 am - 12:00 noon, Level 2, Hall C, H10 This abstract may be accessed online at http://www.asco.org/ at the conclusionof the meeting. The presentation describes two Phase II trials of TroVax in first line treatmentof metastatic colorectal cancer alongside irinotecan-based (IFL) andoxaliplatin-based (FOLFOX) chemotherapy. Oxford BioMedica previously reportedencouraging results from the trials in March 2005. The new data include analysisof immune responses and clinical benefit. Enrolment in the trials was completed in September 2004 with 36 patientsrecruited. The trials are on track to report full safety and immunological dataas well as final tumour response statistics in the second half of 2005. Patientsurvival, which can be compared to historical controls, will be reported oncethe median survival has been reached in the two trials. This is anticipated inearly 2006. Commenting on the ASCO presentation of Phase II results for TroVax, OxfordBioMedica's Chief Scientific Officer, Dr Sue Kingsman, said: "We are verypleased with the progress of TroVax in clinical trials and look forward topresenting new data at ASCO". -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 JohnsonBuchanan Communications Tel: +44 (0)20 7466 5000 Scientific/Trade Press Enquiries:Sue Charles/ Katja Stout/ Ashley LillyNorthbank Communications Tel: +44 (0)20 7886 8150 Notes to editors: 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on the areas ofoncology and neurotherapy. The Company was established in 1995 as a spin outfrom Oxford University, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes an immunotherapy and a gene therapy in multiple Phase II trials, and apreclinical targeted antibody therapy in collaboration with Wyeth. Inneurotherapy, the Company's lead product is a gene therapy for Parkinson'sdisease, which is expected to enter clinical trials in early 2006, and fourfurther preclinical candidates. The Company is underpinned by over 80 patentfamilies, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 65 split between its main facilities inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Amersham,Viragen, MolMed and Kiadis; and has licensed technology to a number of companiesincluding Merck & Co and Biogen Idec. Further information is available at www.oxfordbiomedica.co.uk. 2. TroVax(R) cancer immunotherapy TroVax is Oxford BioMedica's leading cancer immunotherapy product. It isdesigned specifically to stimulate an anti-cancer immune response and haspotential application in most solid tumour types. TroVax targets the tumourantigen 5T4, which is broadly distributed throughout a wide range of solidtumours. The presence of 5T4 is correlated with poor prognosis. The productconsists of a poxvirus (MVA) gene transfer system, which delivers the gene for5T4 and stimulates a patient's body to produce an anti-5T4 immune response. Thisimmune response destroys tumour cells carrying the 5T4 protein. In Phase I/II trials in late stage colorectal cancer patients, TroVax was safeand well tolerated; patients mounted an anti-5T4 immune response; and the immuneresponse correlated, with high significance, to time to disease progression,which translated into a correlation with improved overall survival. Four Phase II trials are underway. Positive initial data from trialsinvestigating TroVax in colorectal cancer in combination with first linestandard of care treatment and as a (neo) adjuvant to surgery were released inMarch 2005. The primary endpoints of safety and immunological responses wereachieved. In the two trials of TroVax alongside chemotherapy, the secondaryendpoint of tumour response rate exceeded expectation. A further Phase II trial is ongoing in renal cell carcinoma, and the US NationalCancer Institute, through the Southwest Oncology Group, is planning a Phase IItrial in breast cancer. 3. ASCO The American Society of Clinical Oncology is the world's leading professionalorganisation representing physicians who treat people with cancer. ASCO'smembers set the standard for patient care worldwide and lead the fight for moreeffective cancer treatments, increased funding for clinical and translationalresearch, and, ultimately, cures for the many different cancers that strikemillions of people around the world every year. This information is provided by RNS The company news service from the London Stock Exchange