EMEA Grants Orphan Drug Status to Active Biotech's Cancer Treatment ANYARA

27-Jul-2007

Active Biotech AB announced that ANYARA has been granted Orphan Drug Status by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA). Orphan Drug Designation provides a variety of incentives, including market exclusivity for up to 10 years following approval. ANYARA, one of Active Biotech's lead oncology candidate drugs, is currently in clinical Phase II/III trials for the indication Renal Cancer.

Active Biotech's ANYARA* project develops a drug for use in cancer targeted therapy, primarily for the treatment of renal cancer. A Phase II/III study is ongoing since the end of 2006. It is a randomized study of ANYARA in combination with interferon-alpha, compared with only interferon-alpha, in patients with advanced renal cancer.

The primary clinical effect parameter for this study is survival and it will include approximately 500 patients at 45 clinics in Europe. Expected survival with conventional treatment for these patients is 10-15 months and the length of the study will depend on the patients' disease progression. An interim analysis based on approximately 200 patients is scheduled for mid-2008.

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