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Progen liver cancer program accelerates

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Progen's recent discussions with FDA suggest that development time for its liver cancer agent PI-88 will be cut by up to three years, Progen announces May 16. In response to FDA's request that the firm submit a special protocol assessment for a Phase III trial, the company plans to advance its current Phase II trial directly to Phase III. The Brisbane, Australia firm notes that "FDA supports a registration approach based on a single pivotal trial" and "an accelerated approval based on meeting the secondary endpoint of disease-free survival." Progen describes PI-88 as a heparan sulfate mimetic; the agent exerts its anti-angiogenic activity by inhibiting VEGF, FGF-1 and FGF-2...

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