OXFORD BIOMEDICA PLC
INTERIM MANAGEMENT STATEMENT
Oxford, UK - 29 October 2010: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), a leading gene therapy company, today publishes its interim management statement for the period from 1 July to 28 October 2010.
ProSavin® (gene-based therapy for Parkinson's disease): development update
· Ninth patient now treated in third cohort (2x dose using enhanced administration technique); Data Monitoring Committee (DMC) to assess results in December
· Subject to DMC approval, treatment of final dose cohort expected to start in Q1 2011
· Approval received from UK Medicines and Healthcare products Regulatory Agency (MHRA) for a second clinical site in Cambridge, UK; expected to open in December
ProSavin®: regulatory update
Oxford BioMedica works closely with the European Medicines Agency (EMA) and US Food and Drug Administration(FDA) on the development of its pipeline products and in June 2010 the Company received formal scientific advice from the EMA on the development path for ProSavin® which validates the current strategy to ensure rapid progress through to registration.
As previously reported, Oxford BioMedica submitted orphan drug applications to the EMA and FDA for the use of ProSavin® in a subset of patients with advanced Parkinson's disease. In September the EMA decided that ProSavin® may be of significant benefit to a much broader patient population and therefore orphan drug designation is not appropriate. The FDA also indicated that the patient numbers in the proposed target population exceed the threshold for orphan drug designation. These opinions support the worldwide potential for ProSavin® in the treatment of Parkinson's disease.
Ocular programmes (gene-based therapies targeting vision loss): development update
· RetinoStat® investigational new drug (IND) application submitted to the FDA in September
· Subject to IND approval, RetinoStat® Phase I/II trial expected to commence in December
· StarGenTM clinical trial application (CTA) dossier on track for submission by year-end
TroVax® (therapeutic cancer vaccine): development update
· First patient treated in Phase II hormone refractory prostate cancer trial
· Phase I/II sponsored study in mesothelioma expected to start in Q1 2011
· Discussions continue for sponsored trials in other cancer indications
The Company's net cash1 balance at 30 June 2010, as reported in the interim report, was £16.3 million. At 30 September 2010 the Company had a net cash1 balance of £13.7 million. Both figures are unaudited.
There are a number of important pipeline development milestones expected over the next 12-18 months. The Company looks forward to the progression of ProSavin® to the next dose level in Q1 2011 and the subsequent data, the further clinical development of TroVax® with its clinical oncology collaborators and the initiation of Phase I/II clinical development programmes for all four of its ocular products, partnered with sanofi-aventis.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: "We believe that there is considerable value to be extracted from our three major programmes and all efforts are focused on securing commercial success. With six pipeline products on track to be in active clinical development by the end of 2011, we remain committed to managing our financial resources and seeking strong collaborations in order to maximise the return across our development pipeline."
For further information, please contact:
Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Andrew Wood, Chief Financial Officer
Lara Mott, Head of Corporate Communications
Tel: +44 (0)1865 783 000
Singer Capital Markets Limited
Shaun Dobson/ Claes Spång
Tel: +44 (0)20 3205 7500
Emma Thompson/Rob Newman/Amber Bielecka
Tel: +44 (0)20 7920 2345
The Trout Group LLC
Tel: +1 (646) 378 2900
Notes to editors
1. Oxford BioMedica®
Oxford BioMedica plc (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 LentiVector® gene delivery system, 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. Further information is available at www.oxfordbiomedica.co.uk.
1 Cash, cash equivalents and current financial assets
This information is provided by RNS