Oxford Biomedica Regulatory News (OXB)

24 Oct 2005 13:49

Oxford Biomedica PLC24 October 2005 FOR IMMEDIATE RELEASE 24 OCTOBER 2005 OXFORD BIOMEDICA CLARIFIES TROVAX(R) STRATEGY Oxford, UK: 24 October 2005 - Oxford BioMedica (LSE: OXB), the leading genetherapy company, provides clarification of its strategy for its lead cancerimmunotherapy, TroVax. Over the past week the Company has made announcements concerning its leadproduct, TroVax; its second anti-cancer clinical product, MetXia(R); itsanti-cancer antibody-targeted therapy in preclinical development with Wyeth; astrategic commercial alliance with Sigma-Aldrich; and, most recently, a furtherlicence agreement for its LentiVector technology. The Company is delighted that it has been able to deliver such positive news tothe market and its shareholders. However, it has received a number of enquiriesfrom shareholders over the course of last week suggesting that there may be someconfusion in the market as to the Company's strategy regarding TroVax. Ittherefore wishes to clarify that:- • in the announcement of encouraging TroVax Phase II data, made on 17October 2005, the Company stated that it intended to secure a developmentpartner for TroVax within the next 12 months. This is entirely consistent withthe previous published guidance that the Company intends to secure such a dealin 2005-06. This guidance is commercially strategic in that it keeps theCompany's options open during discussion with potential partners. The statementmade last week does not represent a change in the Company's plans; • based on current ongoing discussions with potential partners, theCompany does not envisage any requirement to modify TroVax in order to increasethe number of patients that mount anti-cancer immune responses. In comparisonwith published data for other cancer vaccines in clinical trials, TroVax ishighly immunogenic. There are currently no plans to modify the product and alldiscussions with potential partners are based on taking TroVax forward toproduct registration in its current form; and • the Company has spent the last nine months considering the next stageof development of TroVax in various cancer types through detailed consultationwith the regulators (FDA), leading international clinicians and potentialpartners. Although the outcome of this process is yet to be finalised, theoverwhelming body of opinion is that TroVax is ready for Phase III developmentand the nature of such trials is a key point of discussion with potentialpartners. The consensus view is that a Phase IIb study is not required beforeproceeding to Phase III and this is consistent with the Company maintaining itsexpectation of product registration of TroVax in 2009. -Ends- For further information, please contact:Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Tel: +44 (0)20 7466 5000Communications Scientific/Trade Press Enquiries:Sue Charles/ Katja Stout/ Ashley Lilly Tel: +44 (0)20 7886 8150Northbank Communications 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 2006, and four furtherpreclinical 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 inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet,Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to anumber 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 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 over 70 patients treated, TroVax has been safe and well tolerated, andinduced a strong anti-5T4 immune response. In the completed Phase I/II trials,the immune response correlated, with high significance, to time to diseaseprogression, 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. This information is provided by RNS The company news service from the London Stock Exchange