London, UK, 6 July 2011 - Ark Therapeutics Group plc (AKT:LSE) (“Ark” or “the Company”) is pleased to announce that it has been awarded a grant of up to €0.4 million from Finnish Funding Agency for Technology and Innovation (TEKES) to support the further development of Ark’s proprietary lentiviral vector production technology using baculoviruses (“Baculo-lentiviral”) to achieve the scale and GMP quality required for clinical use. Ark has also been awarded a €0.2 million grant from Finnish governmental organization Centre for Economic Development, Transport and the Environment (ELY-centre) to progress validation work in its GMP3 manufacturing facility in Kuopio.
Ark is also pleased to announce that Nature’s Gene Therapy journal has published in its June issue
a paper describing Ark’s latest advances in world leading Baculo-lentiviral vector production technology. This work was conducted by Ark scientists in Kuopio, Finland in collaboration with researchers from the University of Eastern Finland and the IBET institute in Portugal.
Lentivirus can be a highly effective vector for gene therapy applications by virtue of its efficient transduction of both dividing and non-dividing cells, long-term stable transgene expression and low immunogenicity. However, difficulties in plasmid-based production methods have limited its clinical applications. Ark scientists have previously described[ii] Ark’s Baculo-lentiviral production system for lentiviral vector production using adherent cells. The latest improvements described in the June paper are the adaption of the production of lentiviral vectors to a suspension cell culture system using recombinant baculoviruses delivering all elements required for the latest generation of safe, high titer stocks of non-replicating lentiviral vectors. Effective purification by rapid scaleable ion-exchange chromatography was also demonstrated and produced viruses that were shown to mediate effective transduction in vivo.
Ark’s Baculo-lentiviral system makes large scale lentivirus production much more efficient and cost-effective. The support from TEKES and ELY-centre will enable this technology to be established as a production platform within Ark’s GMP manufacturing facility.
Professor Seppo Ylä-Herttuala, Ark’s Consultant Director of Molecular Medicine and the current President of the European Society of Gene and Cell Therapy, commented: “The TEKES and ELY-centre grants and the Baculo-lentiviral publication further demonstrate Ark’s international reputation as a world-leader in gene-based medicines and its pre-eminence in biotherapeutic and viral based manufacturing founded on Ark’s unrivalled viral manufacturing expertise. We look forward to announcing further progress in this area in due course.”
For further information please contact:
Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722
Martyn Williams, CEO
Iain Ross, Chairman
Financial Dynamics Tel: +44 (0)20 7831 3113
Ark Therapeutics Group plc
Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues.
Ark has an early stage pipeline emanating from collaborations with University College, London and the AI Virtanen Institute in Kuopio, Finland, the development of which it intends to progress in collaboration with pharmaceutical and biotech partners.
In addition Ark has the ability to off-set a proportion of its R&D costs and to generate sustainable revenues through the exploitation of its proprietary technology platform, process development, scale-up and manufacturing capabilities on behalf of third parties.
Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Ylä-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom remain consultants on the Company's research and development programmes.
Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L).
This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.
 Lesch HP et al, Gene Therapy 2011 18: 531-8 “Production and purification of lentiviral vectors generated in 293T suspension cells with baculoviral vectors.”
2 Lesch HP et al, Gene Therapy 2008 15: 1280-6 “Generation of lentivirus vectors using recombinant baculoviruses.”
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