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news.European regulators have granted orphan drug status to Antisoma's investigational anticancer compound AS1411 for the treatment of renal and pancreatic cancers.
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This designation will provide a 10-year period of market exclusivity if AS1411 is approved as a treatment for either disease. The drug already has US orphan drug status for both renal and pancreatic cancers.
AS1411 has shown promise in patients with renal cancer; of three patients who participated in a phase I trial, two showed long-term stable disease and one a near-complete response. An extension of this trial is recruiting additional renal cancer patients and will yield new data during 2006.
Pancreatic cancer is one of a number of other cancers in which there are supportive preclinical data for AS1411. Antisoma says that it is working to identify which indications should receive the highest priority for entry into phase II trials.
“The drug’s early promise in renal cancer has opened up the possibility of rapid progress towards the market in this indication, so we are particularly pleased that we now have orphan status for renal cancer on both sides of the Atlantic,” said Antisoma’s CEO, Glyn Edwards.