Oxford Biomedica Regulatory News (OXB)

5 Sep 2006 07:04

Oxford Biomedica PLC05 September 2006 FOR IMMEDIATE RELEASE 5 SEPTEMBER 2006 SOUTHWEST ONCOLOGY GROUP TO START PHASE II TRIAL OF OXFORD BIOMEDICA'S TROVAX IN BREAST CANCER - Regulatory clearance for start of patient recruitment in 120-patient Phase II trial of TroVax in patients with late-stage breast cancer - Oxford, UK - 5 September 2006: Oxford BioMedica (LSE: OXB), a leading genetherapy company, announces that the Southwest Oncology Group (SWOG), a USclinical trials cooperative group, has received regulatory clearance to commencea Phase II trial of Oxford BioMedica's cancer immunotherapy, TroVax, in patientswith late-stage breast cancer. The US National Cancer Institute is sponsoringthe trial and is responsible for the principal costs. In June 2006, SWOG submitted the trial plan to the US Food and DrugAdministration and no issues were raised by the FDA. In August 2006, the studywas submitted to the US Recombinant DNA Advisory Committee and was similarlyaccepted, which means that the trial can now commence. The targeted population for this study will be late-stage (Stage III and IV)breast cancer patients who have received standard therapy and have eitherminimal residual disease or no evidence of disease. These patients are at highrisk of relapse. The current published literature indicates a medianprogression-free survival of 18 to 22 months for this patient group.Approximately 120 patients will be enrolled in this open-label trial. Patientswill receive monthly injections of TroVax for three months, followed by boosterimmunisations at six, nine and 12 months. Key endpoints will include immunological response rates to the 5T4 tumourantigen and progression-free survival versus historical controls. SWOG, which isresponsible for all aspects of the trial, could commence patient enrolmentbefore the end of 2006 in centres in the USA. The trial is expected to completein approximately two to three years. Should this trial prove successful, SWOGmay conduct a Phase III trial in the same setting. This is the first trial of Oxford BioMedica's cancer immunotherapy, TroVax, inpatients with breast cancer. The 5T4 tumour antigen, which is targeted byTroVax, is broadly distributed across most solid tumours. Previous studies haveshown that high levels of the 5T4 tumour antigen are present on over 80% ofbreast cancer cases. To date, approximately 150 patients have been treated withTroVax in ten clinical trials in colorectal, renal and prostate cancer. OxfordBioMedica plans to start a Phase III trial (TRIST) in renal cell carcinoma inthe second half of 2006. Commenting on the progress of SWOG towards starting the Phase II trial in breastcancer, Oxford BioMedica's Chief Medical Officer, Dr Mike McDonald, said: "Weare delighted that the Southwest Oncology Group is committed to evaluate TroVaxas a potential treatment for breast cancer. Given what we know of the product'ssafety profile and the anti-cancer immune response that it stimulates, we arehopeful that TroVax can delay relapse of disease in this population ofadvanced-stage patients." -Ends- For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000 Professor Alan Kingsman, Chief ExecutiveCity/Financial Enquiries: Tel: +44 (0)20 7466 5000 Lisa Baderoon/ Mark Court/ Mary-Jane Johnson BuchananCommunicationsScientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555 Gemma 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 candidates in multiple Phase II trials, and a preclinical targetedantibody therapy in collaboration with Wyeth. A Phase III trial in renal cancerwith TroVax, the lead cancer immunotherapy candidate, is expected to start inthe second half of 2006. In neurotherapy, the Company's lead product is a genetherapy for Parkinson's disease, which is expected to enter clinical developmentin 2006, and four further preclinical candidates. The Company is underpinned byover 80 patent families, which represent one of the broadest patent estates inthe 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, Virxsys and Kiadis; and has licensed technologyto a number of companies including 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. TroVax has attractedexternal support from Cancer Research UK and the US National Cancer Institute.Approximately 150 patients have now been treated with TroVax in ten clinicaltrials (collectively approximately 450 doses). 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 plans to start aPhase III trial (TRIST - TroVax Renal Immunotherapy Survival Trial) in 700patients with advanced renal cell carcinoma in the second half of 2006. TheTRIST study received a Special Protocol Assessment from the US Food and DrugAdministration in May 2006. A Phase II trial in prostate cancer is ongoing and atrial in breast cancer is due to start under the auspices of the US SouthwestOncology Group. 3. Breast Cancer Breast cancer is the leading cause of cancer-related death among women in theUSA and Europe. It is second only to lung cancer. According to the AmericanCancer Society, 212,920 women in the USA will be diagnosed with breast cancer in2006, and 40,970 will die from the disease. Excluding skin cancer, breast canceris the most common form of cancer among women. The numbers are even higher inthe European Union, with an estimated 270,000 new cases of the disease diagnosedannually and 88,000 deaths. While today in the USA, the 5-year relative survivalrate for localised breast cancer is 98%, the figure for patients with distantmetastases is 26%. Analyses of sample tissues from patients with breast cancer have shown that the5T4 tumour antigen is present at high levels on over 80% of breast tumours.Hence, breast cancer is a logical target for a 5T4-targeted immunotherapeutic. 4. Southwest Oncology Group The Southwest Oncology Group (SWOG) is one of the largest cancer clinical trialscooperative research groups in the USA. The Group is a network of more than5,000 physician-researchers located at nearly 550 institutions. In addition totheir regular medical practices, Group investigators work together on clinicaltrials funded by the US National Cancer Institute (NCI), part of the NationalInstitutes of Health, to prevent and treat cancer in adults. Among the Group'sinstitutions are 17 of the NCI's 61 designated cancer centres. The Group enrolsnearly 7,200 patients each year and has about 120 clinical trials underway atany given time. SWOG has its headquarters at the University of Michigan in AnnArbor, Michigan. This information is provided by RNS The company news service from the London Stock Exchange