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news.UK biopharmaceutical firm Antisoma has received notification from the FDA that its drug AS1411 has been granted orphan drug designation in the US for the treatment of renal cancer.
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This provides Antisoma with a seven-year period of market exclusivity for AS1411 upon gaining marketing approval. The compound already has orphan drug designation in the US for the treatment of pancreatic cancer.
Promising signs of activity against renal cancer were reported in a phase I trial of AS1411 presented at this year’s meeting of the American Society of Clinical Oncology (ASCO). Antisoma expects to reopen this trial shortly.
Antisoma’s CEO Glyn Edwards said: “The grant of orphan drug status for AS1411 in renal cancer is a further boost to our development program, strengthening our commercial position in an indication where the drug has shown very promising first results in clinical trials.”