On November 1, 2018 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it will initiate a new clinical program in pancreatic cancer which will be led by Dr. Daniel D. Von Hoff. Dr. Von Hoff is Physician-in-Chief at the Translational Genomics Research Institute ("TGen") and Professor of Medicine at both the Mayo Clinic and the University of Arizona College of Medicine (Press release, Helix BioPharma, NOV 1, 2018, View Source [SID1234531237]).
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Pancreatic cancer is the third leading cause of cancer death in the United States and is very difficult to treat. Treatment options for advanced pancreatic cancer patients are mostly limited to chemotherapy and in certain cases, radiotherapy and surgery. Immunotherapy such as check-point inhibitors, are not widely available as most drug candidates are still in clinical development. It has been speculated that since pancreatic tumours can have a very acidic profile, the application of immunotherapy may be limited.
Based on preliminary but very encouraging internal and collaborative research work with Dr. Robert Gillies of the Moffitt Cancer Center, on animal pancreatic cancer, the Company believes L-DOS47 with its purported action of combating tumour acidity, may contribute significantly to the treatment of pancreatic cancer.
The Company is very excited to work with Dr. Von Hoff on this new clinical program. Dr. Von Hoff is a pioneer in developing new cancer drugs and a prominent opinion leader in the treatment of pancreatic cancer. Dr. Von Hoff’s clinical trial work has led to the approval of three pancreatic cancer drugs by the U.S. Food and Drug Administration ("FDA") for the treatment of patients with advanced pancreatic cancer.
The first clinical study being planned by the Company is a U.S. Phase I/II study of L-DOS47 in combination with Doxorubicin for the treatment of metastatic pancreatic cancer. The Company is currently completing the study protocol and will be looking to submit to the FDA, in the coming months, an investigational new drug ("IND") application.
Given Dr. Von Hoff’s new role in leading this new clinical program, he will be stepping down as a member of the Company’s Advisory Board, effective November 1, 2018. The Company thanks Dr. Von Hoff for his contribution on the Advisory Board and is very much looking forward to Dr. Von Hoff’s valuable ontributions in the Companies pancreatic cancer clinical program.
"We are privileged to work with Dr. Von Hoff and his team on this new clinical program" said Heman Chao,
Helix’s Chief Executive Officer. "Once approved by the FDA, L-DOS47 would be tested in two different
indications, lung and pancreatic cancer. I look forward to starting this new study and am very excited about
expanding the indications of L-DOS47."