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.