7th Nov 2006 07:00
Oxford Biomedica PLC07 November 2006 For Immediate Release 7 NOVEMBER 2006 OXFORD BIOMEDICA commences PHASE III trial OF TROVAX IN RENAL cancer Oxford, UK - 7 November 2006: Oxford BioMedica (LSE: OXB), a leading genetherapy company, announced today that the first patient has been treated inTRIST, a pivotal multi-centre Phase III trial of TroVax, the Company's novelcancer immunotherapy, in patients with advanced or metastatic renal cellcarcinoma (RCC). Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on thestart of the study: "The Phase III TRIST study is designed to demonstratedefinitively that TroVax is effective as a treatment for this aggressive form ofkidney cancer. The clinical experience with TroVax in over 150 patients hasshown indications of its therapeutic potential as well as its excellent safetyprofile." TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial that isdesigned to evaluate whether TroVax immunotherapy, added to first-line standardof care therapy, prolongs the survival of patients with locally advanced ormetastatic clear cell renal carcinoma. The trial is a randomised,placebo-controlled, two-arm study that will compare TroVax in combination withstandard of care to placebo with standard of care. The standard of caretherapies will be interleukin-2, interferon-alpha or Sutent(R) (sunitinib). Theprotocol stratifies treatment between the standard of care options to ensurethat the allocation of TroVax and placebo is rigorously balanced. Approximately 700 patients will be recruited from about 120 centres in the USA,European Union and Eastern Europe. The primary endpoint for the trial issurvival improvement and secondary endpoints include progression-free survival,tumour response rates and quality of life scores. The protocol includes theappointment of a Safety and Efficacy Monitoring Board (SEMB) to assess thesafety and potential efficacy of the drug combinations at various time pointsduring the trial. In May 2006, Oxford BioMedica received a Special Protocol Assessment (SPA)agreement for the TRIST study from the US Food and Drug Administration (FDA).The SPA process enables FDA evaluation of a trial protocol that is intended toform the primary basis of an efficacy claim for product registration. The SPAagreement ensures that the design, conduct, analysis and endpoints of the trialare all acceptable to the FDA. Oxford BioMedica anticipates rapid patient recruitment. Median survival forpatients with advanced or metastatic renal cell carcinoma is approximately 11months. The duration of the trial will be determined by the number of survivalevents (deaths) in the study group. The trial is expected to reach a conclusionin 2008-09, which would support the Company's objective of reaching productregistration in 2009. Commenting on the news, Oxford BioMedica's Chief Executive, Professor AlanKingsman said: "The start of our first Phase III trial is an important milestonefor Oxford BioMedica and ensures that the TroVax programme is on track forpotential product registration in 2009. In addition, starting the Phase IIItrial further emphasises the value of the product to potential partners." The Company remains committed to securing a major corporate partner for theongoing development and commercialisation of TroVax. As reported in September,discussions with lead prospective partners have progressed to developmentstrategies and deal terms. The most advanced prospect is a major pharmaceuticalcompany with a leading oncology franchise that completed its due diligence onthe TroVax programme recently. Oxford BioMedica is working expeditiously withthree other global pharmaceutical companies to bring all four companies to thesame stage of discussions. -Ends- For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor Alan Kingsman, Chief Executive City/Financial Enquiries: Tel: +44 (0)20 7466 5000Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Scientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555Gemma Bradley/ Susan Yu/ Katja StoutNorthbank 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 oncology andneurotherapy. The Company was established in 1995 as a spin out from OxfordUniversity, 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 two clinical candidates and a preclinical targeted antibody therapy,which is being developed in collaboration with Wyeth. The Company has startedPhase III development of its lead cancer immunotherapy product, TroVax, in renalcancer and multiple Phase II trials in various cancer settings are ongoing orplanned. In neurotherapy, the Company's lead product, ProSavin, is expected toenter clinical trials in Parkinson's disease in 2007. The preclinical pipelineincludes gene-based products for vision loss, motor neuron disease and nerverepair. The Company is underpinned by over 80 patent families, which represent one ofthe broadest patent estates in the field. The Company has a staff ofapproximately 70 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica hascorporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed,Virxsys and Kiadis; and has licensed technology to a number of companiesincluding Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) 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. The Company is targetingcolorectal cancer and renal cell carcinoma as lead indications for thedevelopment of TroVax. Renal cell carcinoma is an indication where TroVax mightachieve a rapid route to product registration. Oxford BioMedica has started aPhase III trial (TRIST - TroVax Renal Immunotherapy Survival Trial) in 700patients with advanced renal cell carcinoma. The TRIST study received a SpecialProtocol Assessment from the US Food and Drug Administration in May 2006. APhase II trial in prostate cancer is ongoing and a trial in breast cancer is dueto start under the auspices of the US Southwest Oncology Group. To date, over 150 patients with colorectal, renal or prostate cancer(collectively over 500 doses) have been treated with TroVax. The product hasattracted support from Cancer Research UK, the US National Cancer Institute, andthe UK clinical trials network, QUASAR. These organisations are alreadyconducting or plan to conduct clinical trials with TroVax. At the Annual Meeting of the American Society of Clinical Oncology in June 2006,Oxford BioMedica's scientists and external clinical investigators presentedpromising clinical data from five open-label Phase II studies of TroVax, whichincluded tumour response rates and median survival for patients receiving TroVaxalongside standard therapy. In August 2006, a follow-up analysis of patientsurvival in two Phase II trials in colorectal cancer suggested that TroVax mayprovide a long-term therapeutic effect after treatment has halted. In all trialsto date, the endpoints of safety and anti-tumour immunological responses havebeen achieved with no serious adverse events being attributed to TroVax. 3. Renal Cell Carcinoma Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA.More than 150,000 people are newly diagnosed with RCC worldwide each year.Prognosis is very poor. If RCC has metastasised to other organs at the time offirst diagnosis, the five-year survival rate is less than 5%. In the USA andEurope, RCC accounts for more than 33,000 deaths each year. Data from IMSsuggest that over 5,000 patients in the UK received treatment for metastatic RCCin 2005. The most common form of RCC is known as clear cell, which is evident inapproximately 80% of cases. The other main category is papillary, which is foundin 15-20% of cases. Commonly used treatments for patients with metastatic RCCinclude cytokines such as interferon-alpha, which has limited efficacy, andinterleukin-2, which is associated with severe side effects at high dose levels.In the last 12 months, two novel kinase inhibitor drugs have been approved forthe treatment of metastatic RCC, Nexavar(R) and Sutent(R), based on progressionfree survival and overall response rate data, respectively, rather thanimprovement in survival. There are several reasons why a cancer vaccine such as TroVax might havetherapeutic potential as a novel treatment for RCC. There is circumstantialevidence that immune responses may be important in dictating the outcome for RCCpatients and a vaccine could potentiate this immune response. TroVax, inparticular, may be the vaccine of choice since the expression of 5T4, theantigenic component of TroVax, is more prevalent in RCC than any other solidcancer analysed by Oxford BioMedica: the antigen is present at high levels on ahigh proportion of cells in approximately 90% of RCC tumours. Treatments for RCC generated annual sales of approximately US$600 millionaccording to Datamonitor. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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