Cancer specialists from the Masonic Cancer Center, University of Minnesota, have launched a Phase 1 clinical trial designed to assess the toxicity of Minnelide, a University of Minnesota-developed drug that has successfully disrupted pancreatic cancer development in laboratory tests.
The current trial won’t directly result in drug approval; rather clinicians will work to assess the drug’s safety and establish proper drug dosing. The trial is designed for patients who have seen their disease progress on standard therapy and have no options left to control their disease.
While University experts are optimistic about the future of Minnelide, they caution that success isn’t guaranteed. Only a small number of drugs tested in early Phase 1 trials will ultimately be approved.
According to University experts, if Phase 1 trials yield results similar to those seen in animal models while establishing the drug can be administered safely, Minnelide could gain provisional approval by the U.S. Food and Drug Administration (FDA) under their “breakthrough” designation, which could lead to expanded clinical trials.
To ensure patient safety, the current trial will progress slowly, enrolling patients in cohort groups of three over a period of time that allow continuous assessment for side effects. Such an approach allows researchers to adjust dosing levels to determine the most effective levels for patients while maintaining patient safety.
“Pancreatic cancer is devastating disease, and Minnelide represents hope that we may be able to develop a new approach to combating the disease in patients with no other options,” said Edward Greeno, M.D., a University of Minnesota pancreatic cancer specialist, Masonic Cancer Center researcher and associate professor of medicine. “Most pancreatic cancer patients will die of the disease in just six months; it’s the most lethal cancer we face as physicians. It’s obviously our hope that Minnelide helps us better manage this disease because it could be a tremendous step forward.”
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