Oxford, UK – 18 May 2011: 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 January to 17 May 2011.
PIPELINE UPDATE:
LENTIVECTOR® PLATFORM TECHNOLOGY
ProSavin® (gene-based therapy for Parkinson’s disease): development update
- First three patients in fourth cohort (5x dose) treated
– Initial results due H2 2011 post-review by independent Data Monitoring Committee - Recent six-month assessment of third cohort (2x dose) indicates highest efficacy to date
– Full data set to be presented at the American Society of Gene & Cell Therapy 14th Annual Meeting on 21 May 2011
Ocular programmes (gene-based therapies targeting vision loss): partnered with sanofi-aventis
- RetinoStat®: first dose cohort of three patients on track with initial results expected H1 2012
- StarGen™: Phase I/IIa study on track to commence Q2 2011
- UshStat®: US Recombinant DNA Advisory Committee approval received May 2011
Manufacturing: to support LentiVector® platform clinical programmes
- £1.9 million acquisition of UK production facility in Oxford completed in February 2011
5T4 TUMOUR ANTIGEN PLATFORM
TroVax® (therapeutic cancer vaccine): Phase II collaborative studies update
- Mesothelioma study with Cardiff University and Velindre Cancer Centre
– Favourable Gene Therapy Advisory Committee (GTAC) opinion and approval from Medicines and Healthcare products Regulatory Agency (MHRA) received April 2011, study initiation expected H1 2011 - Colorectal cancer study with Cardiff University
– Protocol submitted to GTAC and MHRA, study initiation expected H2 2011 - Ovarian cancer study with UK National Cancer Research Network (NCRN)
– Protocol submitted to GTAC, study initiation expected H2 2011
Targeted Antibody Therapy (cancer): partnered with Pfizer
- Collaboration broadened in May 2011 to secure in vitro diagnostic rights for a 5T4-targeted antibody therapy in preparation for an Investigational New Drug (IND) application
FINANCIAL REVIEW
The Company’s net cash balance1 at 31 December 2010, as previously reported, was £12.3 million. The placing and open offer which closed on 10 January 2011 raised £18.4 million net of expenses. At 31 March 2011 the Company had a net cash1 balance of £24.6 million (unaudited)
1 Cash, cash equivalents and current financial assets
OUTLOOK
With key pipeline development milestones expected over the next 12 months, Oxford BioMedica remains focused on advancing its core development programmes. The Company looks forward to the results from the higher (5x) dose of ProSavin® later this year, the initiation of multiple Phase II studies for TroVax® by its clinical oncology collaborators and the continued progress of the ocular Phase I/II programme, partnered with sanofi-aventis. Oxford BioMedica’s new manufacturing facility is also on track to be fully operational in H1 2012 to support its five LentiVector® platform clinical programmes.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “We continue to drive progress across our ProSavin®, ocular and TroVax® clinical programmes and remain very encouraged by the quality of our data. With strong partners in sanofi-aventis and Pfizer, it remains a strategic priority to seek the best collaborations for our products in order to maximise value and bring these novel gene-based therapies to market.”
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