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ERYTECH announces FDA’s authorization to proceed with phase 3 trial for Eryaspase in pancreatic cancer

 

ERYTECH Announces FDA’s Authorization to Proceed with Phase 3 Trial for Eryaspase in Pancreatic Cancer in the United States

 

  • Investigational New Drug Application reviewed and accepted
  • Enrollment of US patients expected to begin in Q3 2019
  • Clinical trial authorizations now obtained in all twelve participating countries

 

Lyon (France), Cambridge, MA (U.S.), 13 May 2019 – ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, today announced the acceptance by the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for eryaspase, consisting of the enzyme L-asparaginase encapsulated inside donor derived red blood cells. The acceptance of the IND will enable ERYTECH to initiate enrollment at US trial sites for its ongoing pivotal Phase 3 TRYbeCA1 trial evaluating eryaspase in second-line pancreatic cancer.

 

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