17th Oct 2005 07:00
Oxford Biomedica PLC17 October 2005 FOR IMMEDIATE RELEASE 17 OCTOBER 2005 OXFORD BIOMEDICA PRESENTS ENCOURAGING FINAL PHASE II RESULTS WITH TROVAX(R) IN COLORECTAL CANCER AT THE INTERNATIONAL COLORECTAL CANCER CONGRESS - Confirms safety, immunogenicity and clinical benefit - Oxford, UK: 17 October 2005 - Oxford BioMedica (LSE: OXB), the leading genetherapy company, today announced that further encouraging data were presentedfrom the Phase II trials of TroVax, its cancer immunotherapy, in metastaticcolorectal cancer (CRC) at the Fourth International Colorectal Cancer Congressin Aventura, Florida, USA, on Saturday 15 October 2005. The presentation included a complete and final analysis of safety and immunologyfrom the two Phase II trials with TroVax in first line treatment of CRCalongside irinotecan-based (IFL) and oxaliplatin-based (FOLFOX) chemotherapy.The presentation also included additional information on tumour responses basedon CT scan data. The results confirm the preliminary conclusions that werepresented at the American Society of Clinical Oncology (ASCO) meeting on 15 May2005. The conclusions are that the primary endpoints of safety andimmunogenicity were achieved and that the secondary endpoint of clinical benefithas exceeded the Company's expectation based on tumour responses. Enrolment in the trials was completed in September 2004 with 36 patientsrecruited. A key objective of these studies was to confirm that the anti-tumourimmune response observed in the Phase I/II trial with TroVax as a single agentwas preserved in patients receiving chemotherapy. Analysis, therefore, focusedon "per protocol" patients who received all prescribed cycles of chemotherapyand six immunisations of TroVax. As expected, about one third of patients didnot complete the chemotherapy regimen and, therefore, dropped out of the trialsfor reasons unrelated to TroVax. Across both trials, there were 23 "perprotocol" patients. TroVax was safe and well tolerated in all patients with no serious adverseevents being associated with TroVax treatment. All 23 patients showed ananti-tumour immune response, elicited by TroVax, against the 5T4 tumour antigen.Compared with the Phase I/II study, these Phase II chemotherapy protocols do notappear to impair the ability of TroVax to stimulate an anti-tumour response andmay, in fact, enhance the response at particular time points during the therapy. The human immune system is made up of multiple interacting elements includingthe humoral (antibody) and cell-mediated (T cell) arms. In these Phase IItrials, Oxford BioMedica performed a comprehensive analysis of both arms of theimmune response as detailed below: • Antibody response: Over 90% of patients mounted anti-5T4 antibody responses, which were of higher magnitude and longer duration than those seen in the Phase I/II trial that evaluated TroVax in the post chemotherapy CRC setting. • T cell response: 100% of patients showed T cell responses. 70% of these have been confirmed as cytotoxic T cell (CD8) responses, which, in some patients, were at levels comparable to those observed in response to infectious disease pathogens. The frequency and levels of CD8 responses with TroVax are at the top end of the range in the field of cancer immunotherapy. This is of particular significance because the industry as a whole, including several potential partners for the TroVax programme, believes that it is these CD8 cells that are the main effectors of anti-tumour activity. The secondary endpoint of clinical benefit includes analysis of tumour responsesand overall survival. The number of tumour responses in the trials has beenencouraging so far (NB: the data are unaudited and subject to third partyreview). Across both trials, 91% of patients have shown disease control, whichcomprises complete responses, partial responses and stable disease according toindustry standard RECIST criteria. The detailed tumour response figures are asfollows: • TroVax plus IFL trial: Twelve patients completed the chemotherapy and TroVax regimen. Tumour response data are based on CT scans at 26 weeks. There was one complete response, six partial responses and four patients with stable disease. • TroVax plus FOLFOX trial: Eleven patients completed the chemotherapy and TroVax regimen. Tumour response data are based on CT scans at 14 weeks. There were three complete response, five partial responses and two patients with stable disease. In this trial, an independent statistician identified a statistical relationship (p < 0.02) between the anti-5T4 immune response and tumour responses. Although the trials were small, in terms of patient numbers, and were notdesigned with control arms, the levels of clinical benefit are encouraging whencompared to published trial data for chemotherapy alone in similar settings. Forboth trials, the final audited tumour response figures and patient survival willbe reported in 2006. The trials have not been running long enough to comment onsurvival at this time. The International Colorectal Cancer Congress, which was held in Aventura,Florida, USA, on 14-16 October 2005, is designed as a learning opportunity formedical, surgical, and radiation oncologists as well as gastroenterologists andinternal medicine and primary care physicians. The presentation of the Phase IIresults with TroVax was given by Richard Harrop, Director of Clinical Immunologyat Oxford BioMedica, during a session titled "New Agents of Interest" onSaturday, 15 October 2005. The presentation can be accessed on line atwww.oxfordbiomedica.co.uk. The title of the presentation is "Vaccination withTroVax in Combination with Chemotherapy: A Productive Partnership" The Phase II results are also being presented at another conference calledColorectal Cancer: Molecular Pathways and Therapies on 19-23 October in DanaPoint, California, USA. This meeting is being organised by the AmericanAssociation for Cancer Research (AACR). Oxford BioMedica will make a posterpresentation on Friday, 21 October 2005. Further information is available atwww.aacr.org/page4553.aspx Commenting on the TroVax Phase II results, Oxford BioMedica's Chief MedicalOfficer, Dr Mike McDonald, said: "We are very pleased that the final data fromthe TroVax Phase II trials have confirmed our preliminary conclusions that theproduct is both safe and immunogenic. The tumour response rates are similarlyencouraging. As more data emerge from our Phase II trials, we are increasinglyconfident that TroVax will have a role to play in the treatment of a wide rangeof solid tumours". Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: "One of ourmain goals within the TroVax programme is to secure a development partner withinthe next 12 months. The promising results reported recently from our Phase IItrials in both colorectal and renal cancer have been key in our ongoingdiscussions with prospective partners for TroVax". -Ends- For further information, please contact: Oxford BioMedica plc:Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane JohnsonBuchanan Communications Tel: +44 (0)20 7466 5000Scientific/Trade Press Enquiries: Sue Charles/ Katja Stout/ Ashley LillyNorthbank Communications Tel: +44 (0)20 7886 8150 Notes to editors: 1. Oxford BioMedicaOxford 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, Viragen,MolMed 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) cancer immunotherapyTroVax 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. In over 70 patients treated, TroVax has been safe and well tolerated, andinduced a strong anti-5T4 immune response. In the completed Phase I/II trials,the immune response correlated, with high significance, to time to diseaseprogression, which translated into a correlation with improved overall survival.Four Phase II trials are underway and data to date have been encouraging.Further trials including Phase III trials are planned. 3. International Colorectal Cancer CongressThe Fourth International Colorectal Cancer Congress is an educational andscientific symposium designed to provide participants with leading-edge updatesin the comprehensive management of patients with colorectal cancer, includingthe integration of targeted agents, as well as recent developments inchemotherapy, radiation, and surgical treatments. In addition, the congress willdelve into the biology, screening, diagnosis, and prevention of colorectalcancer. Further information is available at www.cancerconferences.com/conferences/gastro/ccc/ This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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