20th Sep 2005 07:02
Oxford Biomedica PLC20 September 2005 FOR IMMEDIATE RELEASE 20 SEPTEMBER 2005 OXFORD BIOMEDICA PLC INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2005 Oxford, UK: 20 September 2005 - Oxford BioMedica (LSE: OXB), the leading genetherapy company, announced today its interim financial results for the sixmonths ended 30 June 2005. Year to date highlights:Oncology • Encouraging Phase II results with TroVax(R) and chemotherapy in colorectal cancer presented at American Society of Clinical Oncology meeting • Further data from Phase II trials with TroVax to be presented at International Colorectal Cancer Congress from 14 to 16 October 2005 • First stage of Phase II trial with MetXia(R) in pancreatic cancer successfully concluded • Wyeth expects to start trials in next 12 months with Oxford BioMedica's 5T4 antibody targeted therapy for solid tumours • Intervet expects to start trials in next 12 months with Oxford BioMedica's TroVax-Vet(R) in dogs with naturally occurring cancer Neurotherapy • Preparations for clinical trials of ProSavin(R) progressed. Phase I/II trial in Parkinson's disease anticipated to start in 2006 • Preclinical efficacy data with RetinoStat(R) for age-related macular degeneration presented at Association for Research in Vision and Ophthalmology meeting • New grant received for MoNuDin(R) from UK Motor Neuron Disease Association for amyotrophic lateral sclerosis • Preclinical efficacy data with Innurex(R) for spinal cord injury presented at American Society of Gene Therapy meeting Technology Licensing • New license agreements signed with Pfizer and a leading biopharmaceutical company for LentiVector(R) technology • LentiVector licensee, Viragen, reached a milestone in development of an avian transgenic biomanufacturing system. Financial • Cash, cash equivalents and short term investments at 30 June 2005 of £18.6 m • R&D costs lower than last year at £4.8 m (H1 2004: £5.2 m) • Net decrease in cash and short term investments lower than last year at £3.8 m (H1 2004: £5.6 m) Commenting on the interim results, Professor Alan Kingsman, Chief Executive ofOxford BioMedica, said: "Oxford BioMedica has made good progress during the yearto date. Clinical results with the lead products have been highly encouragingand our preclinical candidates in both oncology and neurotherapy have similarlyprogressed. The next 12 months could see three pipeline products start clinicaltrials. Technology licensing has attracted two new partners in the first half ofthe year. Signing new collaborations on our technologies and also ourdevelopment products is a key focus for the company in the next 12 months." -Ends- Today's web cast: Simultaneously to the analyst briefing at 10.00 am on Tuesday 20 September 2005,there will be a live audio web cast of the results presentation. To connect to the web cast facility, please go to the Company's website: http://www.oxfordbiomedica.co.uk/ approximately 10 minutes (09:50 am) before the startof the briefing. This will also be available for replay shortly after thepresentation. 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 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 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 65 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 http://www.oxfordbiomedica.co.uk Chairman's and Chief Executive's Report The first half of 2005 has been an exciting period for Oxford BioMedica,dominated by encouraging Phase II results with TroVax(R) in colorectal cancer.Other major milestones include successful completion of the first stage of thePhase II trial with MetXia(R) in pancreatic cancer, reported in August, andpreclinical efficacy data with RetinoStat(R) in age-related macular degenerationand with Innurex(R) in spinal cord injury. ProSavin(R) for Parkinson's diseaseis progressing towards clinical trials, as are the two partnered cancer productswith Wyeth and Intervet. Commercial discussions are ongoing for a number of Oxford BioMedica's leadproduct candidates. Technology licensing has also flourished following thepartnering initiative implemented last year. In the first half of 2005, thecompany secured two new licensees, including Pfizer, for its LentiVector(R)technology. Another licensee, Viragen, achieved a key development milestoneusing the LentiVector system for avian transgenic biomanufacturing. Oncology Oxford BioMedica's oncology pipeline comprises three major product candidates aswell as a product for treating cancer in companion animals. Clinical resultsreported since the beginning of the year with the company's lead oncologyproducts, TroVax and MetXia, have met or exceeded expectations. Data from three Phase II trials with TroVax in colorectal cancer have confirmedthe product's excellent safety profile and ability to stimulate an anti-cancerimmunological response. In the Phase II trials with concomitant chemotherapy,the majority of patients showed tumour responses in parallel with theanti-cancer immunological effect of TroVax. These interim data were presented atthe American Society of Clinical Oncology in May 2005. The company expects toreport further results from these two trials at an oncology conference later in2005. The first stage of the Phase II trial with MetXia in pancreatic cancer wassuccessfully concluded, demonstrating product safety, gene transfer at thetumour site and identification of the optimal dose. The second part of the trialis underway and initial efficacy results are expected in early 2006. The cancer products in development through collaborations with Wyeth andIntervet continue to progress. The 5T4 targeted antibody therapy for solidtumours with Wyeth, and TroVax-Vet(R) for canine and feline tumours withIntervet, are both anticipated to enter clinical trials in the next 12 months. TroVax(R)TroVax is Oxford BioMedica's advanced cancer immunotherapy product. It isdesigned to stimulate an anti-cancer immune response and has potentialapplication in most solid tumour types. TroVax targets the tumour antigen 5T4,which is broadly distributed throughout a wide range of solid tumours. Theproduct consists of a pox virus (MVA) gene transfer system, which delivers thegene for 5T4. MVA is known to induce the breaking of immune tolerance toself-antigens that are expressed from this gene delivery system. All patients have reached the evaluation stage in the two Phase II trials withTroVax in combination with chemotherapy in colorectal cancer. A further Phase IItrial in colorectal cancer in patients with operable liver metastases isongoing, under the sponsorship of Cancer Research UK. The first trial of TroVaxin renal cell carcinoma, which is being conducted in the United States,continues to recruit patients and further trials in this disease setting areplanned. The US National Cancer Institute (NCI) and the clinical trials consortium,Southwest Oncology Group (SWOG), are finalising the design of a Phase II trialwith TroVax in breast cancer. These organisations provide valuable funding andendorsement of TroVax and plan to conduct a trial that is expected to enrol 120patients with late stage breast cancer. The NCI and SWOG are responsible for allaspects of the trial including the date of commencement. The current expectationis for the trial to start in 2006. The most significant event of the first half of 2005 was the release of interimresults from the two Phase II trials of TroVax in first line treatment ofmetastatic colorectal cancer alongside irinotecan-based (IFL) andoxaliplatin-based (FOLFOX) chemotherapy. The data were presented at the 2005American Society of Clinical Oncology (ASCO) Annual Meeting, in Orlando, Florida, USA, in May. The presentation included the headline data, reported in March 2005, and furtheranalysis of patients' immune responses and clinical benefit. There were 36patients recruited across both trials. The interim results comprised data onpatients that had reached the evaluation stage, which amounted to 25 patientsfor immunological analysis and 19 patients for assessment of clinical benefit. As reported in March, the primary endpoints in the two trials of safety andimmunological responses were achieved. All 25 patients showed an immune responseto the 5T4 tumour antigen. In addition, the secondary endpoint of clinicalbenefit exceeded expectation. Eighteen of 19 evaluable patients responded totreatment, showing either complete or partial tumour shrinkage, or diseasestabilisation following treatment. Although the trial was small, in terms ofpatient numbers, and was not designed with a control arm, this level of clinicalbenefit was encouraging when compared to published trial data for chemotherapyalone in similar settings. The presentation at ASCO showed that the maximum antibody levels (titres)targeted against the 5T4 tumour antigen in the Phase II trials weresignificantly higher than in the earlier Phase I/II trial in post chemotherapypatients. This may be important because, in that earlier study, there was ahighly significant (pRelated Shares:
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