23rd May 2006 07:01
Oxford Biomedica PLC23 May 2006 For Immediate Release 23 MAY 2006 OXFORD BIOMEDICA COMMENCES PHASE II TRIAL OF TROVAX(R) IN PROSTATE CANCER Oxford, UK - 23 May 2006: Oxford BioMedica (LSE: OXB), a leading gene therapycompany, announced today that a Phase II trial of TroVax in patients withprostate cancer that is unresponsive to hormone therapy is open for recruitment.This is the first clinical trial of TroVax in this cancer type. The Phase II trial in prostate cancer is being conducted at the MethodistHospital in Houston, Texas, USA. The Principal Investigator for the trial is DrRobert Amato. The trial is designed to enrol 24 men with hormone-refractoryprostate cancer who have previously received chemotherapy or have refusedchemotherapy and have progressive disease. The trial is open label and will havetwo arms (12 patients each) to assess the activity of TroVax alone versus TroVaxalongside an approved treatment for prostate cancer, granulocytemacrophage-colony stimulating factor (GM-CSF). The primary objectives of the trial are to evaluate the safety and synergies ofthe combination treatment, and to assess whether GM-CSF, which is known toincrease white blood cell count and hence boost the immune system, increases theanti-cancer immune response stimulated by TroVax. Efficacy endpoints includeobjective response rate, progression-free survival, overall survival and changesin prostate-specific antigen (PSA) level, which is a recognised marker ofdisease status. Prostate cancer is the leading cause of cancer in men. Localised radiotherapy orsurgery is potentially curative for early-stage disease although many patientsrelapse and require hormone therapy. However, therapeutic options are limitedwhen the cancer has progressed and no longer responds to hormone therapy, whichis the setting for the Phase II trial of TroVax. Initial data from this trialare expected in the first half of 2007. According to Datamonitor, treatments forprostate cancer generated worldwide sales of $2.7 billion in 2004. Commenting on the start of the Phase II trial in prostate cancer, OxfordBioMedica's Chief Medical Officer, Dr Mike McDonald, said: "We are delightedthat Dr Amato is supporting a Phase II trial of TroVax in prostate cancer. Givenwhat we know of the product's safety profile and the anti-cancer immune responsethat it stimulates, we are hopeful that TroVax can provide a new therapeuticoption for patients with prostate cancer who have progressed despite hormonetherapy and for whom there are few available treatments." Dr Robert Amato, Director of the Genitourinary Oncology Center at the MethodistHospital said: "TroVax could provide a significant benefit to patients withhormone-refractory prostate cancer, particularly when administered with aneffective immunostimulant such as GM-CSF. Our team at the Methodist Hospital hasseen some intriguing clinical responses with TroVax from our trial in renal cellcarcinoma and we are delighted to expand our collaboration with Oxford BioMedicainto prostate cancer." Oxford BioMedica's Chief Executive Officer, Professor Alan Kingsman added: "Aswe broaden and deepen the clinical development of TroVax, the value of our leadproduct candidate increases for potential partners." Clinical evaluation of TroVax is ongoing in renal cell carcinoma, colorectalcancer and now prostate cancer. Oxford BioMedica plans to start a Phase IIItrial in renal cell carcinoma in the second half of 2006. The Company recentlysecured a Special Protocol Assessment agreement with the FDA for this Phase IIItrial. An update on the clinical trials and development plan for TroVax will bereleased to coincide with TroVax presentations at the American Society ofClinical Oncology (ASCO) Annual Meeting, to be held on 2-6 June in Atlanta,Georgia, USA. -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 7886 8150 Katja Stout/ Gemma BradleyNorthbank 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.Over 100 patients have now been treated with TroVax in six clinical trials(collectively over 400 doses). The Company is targeting colorectal cancer andrenal cell carcinoma (RCC) as lead indications for the development of TroVax.Renal cell carcinoma is an indication where TroVax might achieve a rapid routeto product registration. 3. Prostate cancer Prostate cancer is the leading cause of cancer in men. According to the AmericanCancer Society, an estimated 232,090 new cases of prostate cancer were diagnosedin the USA in 2005 and approximately 29,900 men die of this disease annually.The five-year survival rate of men with prostate cancer is 98%, although thisfalls to 34% for metastatic disease. Localised radiotherapy or surgery ispotentially curative for early-stage disease although many patients relapse andrequire hormone therapy. According to Datamonitor, treatments for prostatecancer generated worldwide sales of $2.7 billion in 2004. However, therapeuticoptions are limited when the cancer has progressed and no longer responds tohormone therapy. Early detection is important, and it is recommended that menover the age of 50 have a prostate-specific antigen (PSA) blood test every year. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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