Provectus Pharmaceuticals Inc., a development-stage oncology and dermatology biopharmaceutical company, has initiated a Phase 1 study of their drug – PV-10 – for liver cancer. The study will enroll up to six subjects with cancer metastatic to the liver or with recurrent liver cancer. The same drug is currently undergoing Phase 2 study for metastatic melanoma.
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 liver cancer. Additional objectives are to assess the distribution and retention of PV-10 in the injected lesion, tumor response and viability, and plasma pharmacokinetics of the drug following intralesional injection.
The CEO of Provectus, Dr. Craig Dees, PhD, spoke about the Phase 1 trial, “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.”
The company’s leading oncology drug, PV-10, is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly 30 years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect liver ailments. Rose Bengal has an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys.
Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer cells via a process called chemoablation whereby cancer cells undergo a form of cell death that mimics both features of necrosis and apoptosis. PV-10 does this without damaging surrounding healthy tissue, significantly reducing systemic side effects.