16th Nov 2005 07:03
Oxford Biomedica PLC16 November 2005 IMMEDIATE RELEASE 16 NOVEMBER 2005 OXFORD BIOMEDICA COMMENCES SECOND PHASE II TRIAL WITH TROVAX(R) IN RENAL CELL CARCINOMA Oxford, UK: 16 November 2005 - Oxford BioMedica (LSE: OXB), a gene therapycompany, announced today that the first patient has been treated in a secondPhase II trial with TroVax in combination with interleukin-2 (IL-2) in patientswith metastatic renal cell carcinoma (RCC). There are now five Phase II trialsongoing with TroVax in RCC and colorectal cancer. The first patient was treated in a second Phase II trial in RCC at the MethodistHospital in Texas, US, on 14 November 2005. This open label trial is expected torecruit up to 25 patients. The Principal Investigator for the trial is Dr RobertAmato, who is an internationally recognised opinion leader in the treatment ofRCC. The trial is designed to evaluate the safety and immunogenicity of TroVaxin conjunction with low dose IL-2, which is commonly used in the treatment ofRCC. Initial data from this trial are expected in the first half of 2006. The Company is targeting RCC as a lead indication for the development of TroVax,in addition to colorectal cancer. As reported on 2 November 2005, the Companybelieves that RCC is an indication where TroVax might achieve a rapid route toproduct registration. The Company aims to initiate a Phase III trial of TroVaxin RCC in 2006 and is targeting product registration in 2009. In parallel, theCompany is conducting negotiations with potential partners for TroVax. Thecurrent treatment market for RCC is approximately US$600 million according toDatamonitor. Commenting on the news, Oxford BioMedica's Chief Medical Officer, Dr MikeMcDonald, said: "We are delighted to have Dr Amato's support for the TroVaxprogramme as we also prepare to begin a large randomised Phase III registrationtrial in mid 2006. The Phase III trial will assess the impact of TroVax inprolonging survival of patients with this rapidly progressive disease." -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 Mobile: 07721 413 496Buchanan Communications Tel: +44 (0)20 7466 5000Scientific/Trade Press Enquiries:Katja Stout/ Hannah CarterNorthbank 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 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. TroVax is currently in five Phase II trials, including an investigator initiatedtrial sponsored by Cancer Research UK. Over 85 patients have been treated withTroVax (collectively over 350 doses) in five clinical trials in colorectalcancer and renal cell carcinoma. Clinical results have shown that the product issafe and stimulates an anti-tumour immune response against 5T4 in the majorityof patients. Data from the completed Phase I/II trial and ongoing Phase IItrials suggest that the magnitude of the immune response induced by TroVaxcorrelates with clinical benefit including tumour responses and time to diseaseprogression, both of which have exceeded expectation based on publishedhistorical data. A Phase III trial in renal cell carcinoma is planned to startin 2006. 3. Renal Cell Carcinoma Renal cell carcinoma (RCC) is the most common form of kidney cancer and thetenth most common cancer in the United States. More than 150,000 people arenewly diagnosed with RCC worldwide each year. Prognosis is very poor. If RCC hasmetastasised to other organs at the time of first diagnosis, the five-yearsurvival rate is less than five per cent. In the United States and Europe, RCCaccounts for more than 33,000 deaths each year. There are no approved treatments to date that prolong the survival of metastaticRCC patients. Commonly used treatments for patients with metastatic RCC includecytokines such as interferon-alpha, which has limited efficacy, andinterleukin-2, which is associated with side effects. About 40 per cent ofpatients with RCC develop metastases after surgery. Analyses of sample tissues from patients with RCC have shown that the 5T4 tumourantigen is present at high levels on approximately 90 per cent of tumours.Hence, RCC is a logical target for a 5T4-targeted immunotherapeutic. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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