Provectus Initiates Phase 1 Trial For Liver Cancer
To determine the safety and tolerability of a single intralesional injection of PV-10
Provectus has initiated a phase 1 study of PV-10 for liver cancer. The study will enroll up to six subjects with cancer metastatic to the liver or with recurrent liver cancer. PV-10, a injectable formulation of Rose Bengal, is used as an intravenous diagnostic to detect ailments of the liver. PV-10 is currently undergoing phase 2 study for metastatic melanoma.
The company said that the primary objective of the open-label study is to determine the safety and tolerability of a single intralesional injection of PV-10 in patients with cancer of the liver. Additional objectives are to assess the distribution and retention of PV-10 in the injected lesion, tumor response and viability, and plasma pharmacokinetics of PV-10 following intralesional injection.
In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort.
Craig Dees, CEO of Provectus, said: “Patients with liver cancer currently have very little choice and a terrible prognosis if the cancer cannot be fully removed through surgery, as the disease is usually deadly within months. We hope to demonstrate that PV-10, which has shown excellent selectivity for melanoma, will be a viable therapeutic for liver cancer and cancers metastatic to the liver.”
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