Pancreatic cancer is among the most deadly of cancers, showing an average 5-year survival rate of less than 10%. It is also considered to be one of the most hypoxic cancers. Pancreatic tumors result from the uncontrolled growth of exocrine or endocrine pancreatic cells which are responsible for digestive enzyme secretion or hormonal regulation of blood sugar levels, respectively. The high mortality rate of pancreatic cancer can be attributed in part to its insidious nature whereby in the majority of cases symptoms present in late-stage disease.
The standard of care intervention for pancreatic cancer is surgery to remove the tumor followed by combination (adjuvant) radiation and chemotherapy. Surgical resection, when possible, involves removing the part or whole of the pancreas affected as well as surrounding structures and reconnecting the digestive tract. Radiation treatment and chemotherapy and Abraxane is then used to attempt to eliminate any remaining cancer cells.
Recently, the U.S. Food and Drug Administration approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer. In the pivotal clinical trial, patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin.
Clinical trials of other new drugs in metastatic disease feature various approaches to the treatment of pancreatic cancer. While encouraging, none of these drugs has yet to significantly improve the overall survival rate, thus highlighting the importance of additional drugs to meet the medical need.
Because of the safety history of TSC to date, Diffusion should be able to move directly into Phase 2 trials for this indication.