07/01/2009
Ark commences contract manufacture for Lx Therapies VEGF-C gene medicine programme
London, UK, 1 July 2009 - Ark Therapeutics Group plc ('Ark' or the 'Company') announces today that it has signed an agreement with the private Finnish biotechnology company, Oy Lx Therapies Ltd ('Lx Therapies'), to produce Vascular Endothelial Growth Factor C in an Adenoviral Vector (Ad VEGF-C). Under the agreement, Ark will undertake all manufacturing and filling activities for pre-clinical use and future clinical production of Ad VEGF-C and make available certain regulatory documentation to allow Lx Therapies to undertake full development and registration of Ad VEGF-C for the treatment of diseases of the lymphatic system. Work will be undertaken in Ark's facility in Kuopio, Finland. Commercial terms of the agreement were not disclosed.
VEGF-C is a member of the VEGF family of angiogenic growth factors which, due to its receptor binding activity pattern, is particularly active in the lymphatic system. Ark will undertake a full programme of manufacturing development and production, commencing with adenovirus clone selection and master cell bank production through to master and working seed stock creation and manufacturing and filling to preclinical and clinical standards. VEGF-C will be manufactured in an adenovirus vector (Ad5) identical to the one successfully used in Ark's glioma (brain tumour) product CereproŽ, currently undergoing EMEA review marketing authorisation in the European Union. Work on the first stage of clone selection and optimisation for Ad VEGF-C will commence immediately.
Lx Therapies is initially developing Ad VEGF-C for the treatment of breast cancer associated lymphoedema, a common complication of breast cancer treatment. An axillary (arm pit) lymph node dissection, whilst beneficial in the cancer diagnosis and treatment, damages the lymphatic vasculature in the affected arm. Lymphoedema, a chronic, progressive swelling of the arm, is a disabling and disfiguring condition for which there is no cure or effective treatment today.
Lx Therapies plans to use Ad VEGF-C in connection with lymph node transplantation. Work to date in relevant disease models shows that Ad VEGF-C treatment at the time of node implant induces lymphangiogenesis and the existing lymphatic vessels join rapidly to the implanted node, restoring its function to drain fluid and pathogens. The data was presented at the European Plastic Surgery Meeting in Barcelona, Spain in May 2009 and was presented in the World Congress for Reconstructive Microsurgery in Okinawa, Japan in June 2009.
Dr Nigel Parker, CEO of Ark, commented: "We are very pleased that Lx Therapies has selected Ark for this work. We can provide them with the full technology expertise and manufacturing support for their development programme using Ad VEGF-C in lymphangiogenesis. Effective lymph node transplantation is a key area of unmet medical need for breast cancer patients and the work so far by Lx Therapies looks very promising."
Prof Markku Jalkanen, Chairman of Lx Therapies, added: "This agreement catalyses our business. Access to Ark's manufacturing capabilities and to their IP and regulatory expertise, the combination of which we believe is the most advanced in the sector, will shorten our time to market and significantly increase the chances of development success. We are looking forward to working with the Ark team in Finland and to executing the 'lead up' preclinical work to take us to Phase I/II clinical studies."
