On July 9, 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 the submission of an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for approval to initiate a Phase I/II clinical study protocol with L-DOS47, to be given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer (Press release, Helix BioPharma, JUL 9, 2019, View Source [SID1234537433]).
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Pancreatic cancer is the seventh leading cause of cancer related deaths in the world. In the United States alone, it is estimated that over 56,000 adults will be diagnosed with the disease and over 45,000 patients will succumb to the disease, this year. The 5-year survival rate for those who suffer from late stage metastatic pancreatic cancer is 3%.
Despite advancements in immunotherapies, the complex tumor microenvironment of pancreatic cancer has been recognized as a significant barrier in treating patients. One of the significant obstacles in treating these patients is the underlying metabolic and structural characteristics of the cancer which leads to significant acidosis. Helix’s DOS47 technology is designed to fight acidosis and restore immune cell activities. This new study is not only designed to demonstrate the safety profile of L-DOS47 but to also quickly provide a pilot assessment on efficacy.
"L-DOS47 represents a uniquely novel approach in treating cancer," said Dr. Heman Chao, Helix’s Chief Executive Officer. "We are leading a path in applying this methodology in order to modulate the tumor microenvironment. We look forward to demonstrating L-DOS47 as a safe and potentially breakthrough treatment alternative for this difficult disease."