Last checked at 19 Nov 2009 07:00
| For Immediate Release | 19 NOVEMBER 2009 |
OXFORD BIOMEDICA PLC
INTERIM MANAGEMET STATEMENT
Oxford, UK - 19 November 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today publishes its interim management statement for the period from 1 July to 18 November 2009.
Highlights
TroVax®: clinical and regulatory support for further trials in several cancer settings
ProSavin®: modified administration has potential to enhance and accelerate development
Ocular programmes: on track to start clinical trials in 2010 with sanofi-aventis
Financial review: cash burn in line with budget
TroVax® (cancer): clinical and regulatory support for trials in several cancer settings
Interim results from the Phase III TRIST study of TroVax in renal cancer were presented at the joint congress of the European Cancer Organisation and the European Society for Medical Oncology in September. As previously reported, the TRIST study did not achieve its primary endpoint of an improvement in survival. However, the results confirmed the findings from previous trials, demonstrating that the anti-5T4 immune response induced by TroVax is associated with enhanced survival. Encouragingly, TroVax showed statistically significant survival benefit in one of the pre-defined patient subsets.
Exploratory analyses of the TRIST data identified a relationship between patients' blood cell counts and TroVax-related survival benefit. In patients with aberrant levels of certain blood cells at the start of the study, TroVax appeared to be less beneficial. Excluding these patients, there was a promising survival trend in favour of TroVax versus placebo. In this patient group, which represented more than 50% of the TRIST population, the indicative efficacy of TroVax was consistent with the level required to meet the study's primary endpoint. In future trials, the ability to select patients who are more likely to mount stronger anti-5T4 immune responses and benefit from TroVax potentially increases the predictability of clinical outcome and the likelihood of successful development.
The competitive landscape for the treatment of renal cancer is considerably more crowded today than when the TRIST study was initiated in 2006. As a result, other cancer settings may offer a more attractive initial route to market for TroVax. The TRIST results have been discussed with the US Food and Drug Administration (FDA). Several settings for possible further development were presented to the FDA. These included ovarian cancer, hormone-refractory prostate cancer and triple-negative breast cancer, which have clear unmet needs and a lack of effective treatments. The agency was supportive of these proposed indications for trials of TroVax. Based on our extensive Phase II data, the FDA also invited submissions for Phase II or adaptive Phase II/III trials in metastatic colorectal cancer.
Following the outcome of the FDA's review in July, we embarked on an initiative to re-partner TroVax. Based on preliminary feedback, prospective partners are attracted by the potential to select patients that are more likely to benefit from TroVax. There remains strong support from clinicians for conducting further trials in our targeted settings and we are exploring funding options through clinical networks. Partnering TroVax for Phase III development remains a key strategic priority for Oxford BioMedica, and discussions are ongoing. Prior to securing a partner, we would only consider supporting cost-effective Phase II trials that are designed to demonstrate proof of concept at the earliest opportunity.
ProSavin® (Parkinson's disease): potential to enhance and accelerate development
We reported further encouraging data from the Phase I/II dose-escalation study of ProSavin in October. Patients at the second dose level showed greater improvement in motor function at their six-month assessments compared to three months. The maximum improvement was 53% and the average was 34% relative to baseline. If confirmed in placebo-controlled studies, ProSavin would represent a significant advance to current treatment options, given its potential to enhance patients' quality of life and suppress the complications caused by oral L-DOPA therapy.
The excellent safety profile and promising efficacy of ProSavin at the first and second dose levels justify further escalation of the dose. The French regulatory agency (AFSSAPS) is evaluating our proposal to escalate to the allometric human equivalent of the highly efficacious preclinical dose level. In addition, we are seeking to modify the administration procedure using an injection technique that requires fewer needle tracks and reduces the surgery time. Both the study's Data Monitoring Committee and the Company's Scientific Advisory Board support this strategy. Enhancing the efficacy of ProSavin and reducing the surgery time could accelerate the overall development timelines and expand the market opportunity. We anticipate guidance on our proposed amendment from the AFSSAPS before the end of 2009.
The ground-breaking preclinical results were published in the 14 October issue of Science Translational Medicine, a leading scientific journal. The paper described several proof-of-concept studies in the industry-standard preclinical model of severe Parkinson's disease. In this model, ProSavin significantly increased dopamine production from 27% to 47% of normal concentrations without the addition and side-effects of standard L-DOPA therapy. The timing of the publication supports our initiative to raise the profile of ProSavin in other territories and to engage with the European regulatory agency (EMEA) and the FDA.
As we advance to larger trials, we are negotiating with prospective partners who could add value through their expertise in Parkinson's disease and could bring additional resources for the next stage of development. Our collaboration strategy is to retain certain territorial rights to establish our own specialist sales force for commercialisation of ProSavin.
Ocular programmes: on track to start clinical trials in 2010 with sanofi-aventis
Our collaboration with sanofi-aventis, signed in April, supports the development of our four LentiVector®-based product candidates for ocular diseases. In addition to the upfront payment received, sanofi-aventis has committed up to US$24 million over a three-year period to reimburse our development costs. All four programmes are progressing towards clinical development in 2010-11.
The most advanced candidate is RetinoStat® for wet age-related macular degeneration. We have had a constructive dialogue with the FDA regarding the planned Investigational New Drug (IND) application. The requirements for the IND have been agreed with the agency and we are on track to complete the non-clinical package and submit our IND application in the second half of 2010.
Our second candidate, StarGen™ for Stargardt disease, is also expected to enter clinical development before the end of 2010. We aim to conduct the Phase I/II trial in France with Professor José-Alain Sahel, Head of the Ophthalmology Department at the Quinze-Vingts Hospital in Paris. Preparations are ongoing and we plan to engage the AFSSAPS within the next few months for formal guidance on our Clinical Trial Application.
Financial review: cash burn in line with budget
In our interim results, we reported that our net cash1 balance at 30 June 2009 of £34.8 million was sufficient to support our operations into 2012. Expenditure and net cash outflow in the subsequent period to 18 November have been in line with this budget. We continue to review our development priorities against our goals of maximising value and minimising risk through collaborations. We expect to report a net cash inflow for the current year following the significant cash receipts from sanofi-aventis in the first half of 2009 relating to our ocular collaboration and the return of rights to TroVax.
Oxford BioMedica's Chief Executive Officer, John Dawson, commented: "We have made real progress during the period in both our development and commercial activities. The Phase I/II study of ProSavin continues to yield encouraging data and we are excited by the potential for further enhancement at the next dose level. TroVax is attracting increasing interest and we are working with leading clinicians who have expressed interest in conducting further trials. Our ocular collaboration with sanofi-aventis is on track and the first two products are expected to enter the clinic in 2010. Our partnering efforts are focused on ProSavin and TroVax and we are pursuing other opportunities to accelerate the transformation of Oxford BioMedica into a sustainable biopharmaceutical company. Looking back over my first year as Chief Executive, I am pleased to reflect on our achievements and I look forward to building on this progress."
1. Cash, cash equivalents and current financial assets
-Ends-
| For further information, please contact: | |
| Oxford BioMedica plc: John Dawson, Chief Executive Officer Nick Woolf, Chief Business Officer | Tel: +44 (0)1865 783 000 |
| JPMorgan Cazenove Limited: James Mitford/ Gina Gibson | Tel: +44 (0)20 7588 2828 |
| Media/Financial Enquiries: Lisa Baderoon/ Mark Court Buchanan Communications | Tel: +44 (0)20 7466 5000 |
| US Enquiries: Thomas Fechtner The Trout Group LLC | Tel: (646) 378 2900 |
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient gene delivery system (LentiVector®), which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer (formerly Wyeth). Technology licensees include Biogen Idec, GlaxoSmithKline, Merck & Co and Pfizer. Further information is available at www.oxfordbiomedica.co.uk