Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, 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 is the company’s lead oncology drug candidate that is also 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 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. Dr. Paul Goldfarb, M.D., of Sharp Memorial Hospital in San Diego, will be the Principal Investigator for the study, which is expected to begin enrolling subjects within the next several weeks.
Dr. Craig Dees, PhD, 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.”
Malignant lesions in the liver arising from primary hepatocellular carcinoma (HCC) or metastases from a wide range of cancers represent an ongoing treatment challenge for oncologists. HCC is one of the most common malignancies worldwide, and its incidence is rapidly increasing in the United States. The liver is a common site of metastases from solid tumors, particularly those arising in the gastrointestinal tract. Other tumors, such as lung and breast cancer and melanoma, also readily spread to the liver.