On August 7, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase Ib/II study of L-DOS47 and doxorubicin in advanced metastatic pancreatic cancer (Press release, Helix BioPharma, AUG 7, 2019, View Source [SID1234538499]).

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This is an open label, non-randomized study designed to evaluate the safety, tolerability and preliminary activity of L-DOS47 in combination with doxorubicin in patients with metastatic pancreatic cancer who have progressed on at least two prior treatment regimens.

Phase Ib will involve a dose escalation safety run-in to determine the appropriate dose to be used in combination with doxorubicin for Phase II. Phase II will evaluate preliminary anti-tumor activity and safety of the Maximum Tolerated Dose of L-DOS47 given in combination with doxorubicin.

"We are very pleased to gain this approval from the FDA," said Dr. Herman Chao, Helix’s Chief Executive Officer. "This represents an expansion of the L-DOS47 application from treating lung cancer to potentially benefiting pancreatic patients. The team is already hard at work to begin all the necessary preparatory activities to move the trial forward. We look forward to be ready to dose patients at the earliest opportunity."