Danish cancer drug gets FDA approval for US clinical trial  

FDA approves Phase I trial of Pharmexa’s breast cancer drug HER-2 Protein AutoVac

The US health authorities (FDA) have approved a Phase I trial of Danish biotech company Pharmexa’s breast cancer drug HER-2 Protein AutoVac. The trial is expected to get under way in May 2003 and the results should be available early in 2004. The FDA approval brings the Danish company one step closer to a USD 500 million market which Roche is currently occupying with its breast cancer drug Herceptin.


The trial will take place at two US breast cancer centres and is planned to involve around 10 patients with advanced HER-2 positive breast cancer. The HER-2 protein is found in up to 30% of breast cancers and is implicated in cancer cell division and growth. The primary objective is to assess the safety of Pharmexa’s HER-2 Protein AutoVac product as well as the product’s ability to activate a specific immune response against cancer cells. The news is reported by daily newspaper Berlingske Tidende and on Pharmexa’s website.

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