9th Nov 2006 07:03
Oxford Biomedica PLC09 November 2006 For Immediate Release 9 NOVEMBER 2006 OXFORD BIOMEDICA REPORTS FURTHER ENCOURAGING PHASE II RESULTS WITH TROVAX(R) IN RENAL AND PROSTATE CANCER - Presentations at the 18th EORTC-NCI-AACR Symposium, 7-10 November 2006 in Prague, Czech Republic - Oxford, UK - 9 November 2006: Oxford BioMedica (LSE: OXB), a leading genetherapy company, announced today that Dr. Robert Amato has presented furtherencouraging data from three Phase II trials of TroVax, the Company's lead cancerimmunotherapy product, in renal cell carcinoma and prostate cancer at the 18thEORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics", whichis being held on 7-10 November 2006 in Prague, Czech Republic. http://www.fecs.be/emc.asp?pageId=973&Type=P Dr. Amato of the Genitourinary Oncology Centre, the Methodist Hospital inHouston, USA, is the Principal Investigator for two ongoing Phase II trials ofTroVax in renal cell carcinoma (RCC) and a Phase II trial of TroVax in prostatecancer. The RCC trials are designed to evaluate the safety, immunogenicity andeffectiveness of TroVax as a single agent and in combination with standardtherapy of interleukin-2 (IL-2) or interferon-a (IFN). The regimen comprisesseven intramuscular injections of TroVax over 41 weeks. To date, the two trialshave enrolled 33 patients with progressive metastatic RCC and 18 patients arecurrently receiving therapy. All patients were heavily pre-treated beforeentering the trials. Dr. Amato presented data showing that TroVax was welltolerated and has shown promising anti-tumour activity in this patient group.One patient had a complete response (tumour eradication) and two patientsdeveloped a partial response (tumour shrinkage). A further 15 patients showeddisease stabilisation for periods exceeding three months, including one patientthat has been stable for more than 46 weeks. Overall survival in the two studiesis too early to assess and has yet to reach a median. The immunological analysisis ongoing but a preliminary assessment has shown that TroVax induced5T4-specific antibody responses in more than 90% of evaluable patients.Importantly, in patients with clear cell RCC, there was a statisticallysignificant correlation (p=0.028) between the immune response to 5T4 andclinical benefit based on changes in patients' tumour burden. This isparticularly encouraging since it supports the rationale that the 5T4-specificimmune response induced by TroVax has therapeutic benefit. Clear cell RCC is themost common subtype of renal cancer and is the patient group for the Phase IIITRIST study. The Phase II trial in prostate cancer is similarly designed to evaluate thesafety and immunogenicity of TroVax as a single agent and in combination withstandard therapy of GM-CSF. The regimen comprises ten intramuscular injectionsof TroVax over 45 weeks. The trial has enrolled 27 patients withhormone-refractory prostate cancer and eight patients continue to receivetherapy. TroVax was well tolerated and all patients developed a strong5T4-specific antibody response whether or not they received GM-CSF. Analysis ofcytotoxic T-cell immune responses stimulated by TroVax in the renal and prostatecancer trials is ongoing. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the newdata: "We are very encouraged by the data emerging form these Phase II trials.The data provide further evidence that TroVax can be administered safely andthat it induces consistent antibody responses to the target tumour antigen 5T4.The correlation between immune and clinical responses supports our Phase IIIdevelopment strategy of TroVax in renal cancer". -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. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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