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Ark To Make Lymfactin for Laurantis

Finnish pact begins with Phase I

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ark Therapeutics has been selected to manufacture and supply Lymfactin to Laurantis Pharma under a conditional agreement announced today by the Finland-based companies. The agreement is subject to Laurantis receiving regulatory approval to commence its Phase I trial. Terms of the agreement were not disclosed.

Lymfactin uses an adenoviral vector to deliver vascular endothelial growth factor (VEGF-C) during transplantation of lymph nodes in order to avoid lymphedema. Ark is a CDMO focused on viral products, with R&D and GMP manufacturing in Finland and the UK

The Phase I clinical trial using Lymfactin to treat breast cancer-associated lymphedema is targeted to begin in 2013, and will recruit patients in the U.S. and Finland. Breast cancer-associated lymphedema is the most common form of secondary lymphedema, occurring in approximately 20% of breast cancer patients who undergo axillary lymph node dissection. The incidence is even higher in those who also receive radiotherapy, and this complication may even occur in those who undergo a lymph node biopsy as part of treatment. No therapeutic treatment currently exists to treat this disease.

In the U.S., approximately 110,000 patients are living with breast cancer-associated lymphedema, and nearly 15,000 new patients develop the complication each year. The number of lymphedema patients in Europe is estimated to be roughly the same as in the U.S.

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