12th May 2006 07:00
Oxford Biomedica PLC12 May 2006 For Immediate Release 12 MAY 2006 OXFORD BIOMEDICA SECURES AGREEMENT WITH FDA ON SPECIAL PROTOCOL ASSESSMENT FOR PHASE III TRIAL OF TROVAX IN RENAL CANCER Oxford, UK - 12 May 2006: Oxford BioMedica (LSE: OXB), the leading gene therapycompany, announced today that it has received a Special Protocol Assessment(SPA) agreement from the US Food and Drug Administration (FDA) for a Phase IIItrial of TroVax in renal cell carcinoma. The written agreement from the FDAspecifies the design, conduct, analysis and endpoints of the trial, which, ifsuccessful, will support an efficacy claim in a regulatory submission forproduct registration. The SPA was received at the end of the FDA's first reviewperiod following Oxford BioMedica's application in March 2006. Oxford BioMedicaplans to start the trial in the second half of 2006. The Phase III trial, referred to as TRIST (TroVax Renal Immunotherapy SurvivalTrial), will evaluate whether TroVax immunotherapy, added to first line standardof care therapy, prolongs the survival of patients with locally advanced ormetastatic clear cell renal adenocarcinoma. The trial will be a randomised,placebo-controlled, two-arm study of TroVax in combination with standard of careversus placebo with standard of care. Standard of care will be interleukin-2,interferon-alpha or Sutent(R) (sunitinib). Study treatment will be stratifiedbetween the standard of care options to ensure that the allocation of TroVax andplacebo is rigorously balanced. Recruitment will be approximately 700 patientsin about 120 centres in the USA, European Union and Eastern Europe. The primaryendpoint will be survival improvement and secondary endpoints will includeprogression free survival, tumour response rates and quality of life scores. Theprotocol includes the appointment of a Safety and Efficacy Monitoring Board(SEMB) to assess the safety and potential efficacy of the drug combinations atvarious time points during the trial. Oxford BioMedica is also discussing the TRIST trial with regulatory authoritiesin Europe. In addition, the Company plans to seek 'orphan drug' designation forTroVax in both the USA and Europe for renal cell carcinoma. The granting oforphan drug status would provide Oxford BioMedica and any prospective commercialpartner with various benefits in terms of regulatory exclusivity, assistancewith clinical development and a waiver of filing fees. Oxford BioMedica's Chief Medical Officer, Dr Mike McDonald, said: "We aredelighted to have secured the SPA within such a short time period. We haveworked closely with the FDA on the design of the TRIST study and they have beenextremely supportive. We look forward to starting this pivotal trial of TroVaxin a cancer setting where there are few treatment options and there is a needfor new approaches that are both safe and effective." Commenting on the SPA, Oxford BioMedica's Chief Executive, Professor AlanKingsman, said: "This is a significant milestone for the Company. It representsthe successful achievement of the first of our major goals for 2006." -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 BuchananCommunications Scientific/Trade Press Enquiries: Tel: +44 (0)20 7886 8150Katja 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. 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. To date, neitherradiation, chemotherapy, nor hormonal therapy prolongs the survival ofmetastatic RCC patients. Commonly used treatments for patients with metastaticRCC include cytokines such as interferon-alpha, which has limited efficacy, andinterleukin-2, which is associated with severe side effects at high dose levels.Two new drugs have recently received US approval for the treatment of metastaticRCC, Nexavar(R) and Sutent(R), although there are no published data showing thatthey offer a survival benefit. There are several reasons for considering that a cancer vaccine such as TroVaxmight be highly appropriate for this patient group. 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. 5T4 is present at high levels on a highproportion of cells in approximately 90% of tumours. Treatments for RCCgenerated sales of $600 million in 2004 according to Datamonitor. 4. Special Protocol Assessment (SPA) The FDA's SPA process was implemented under the Prescription Drug User Fee Act(PDUFA) in November 1997. Under the SPA process, the FDA assesses the protocoldesign, conduct and data analyses of a trial. Once the protocol is agreed inwriting, then the assessment is binding on the review division of the FDA aslong as the protocol is followed, unless substantial scientific issues essentialto determining the safety or efficacy of the drug are identified later. Clinicalprotocols for Phase III trials that are assessed under the SPA process can formthe primary basis of an efficacy claim in a marketing application submitted tothe FDA. Further information on the SPA process is available at www.fda.gov This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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