Provectus Pharmaceuticals, Inc. a development-stage oncology and dermatology biopharmaceutical company, has completed patient accrual and treatment of all subjects in its phase 1 clinical trial of PV-10 for liver cancer.
Dr Craig Dees, PhD, CEO of Provectus said, “Preliminary results for PV-10 as a treatment for liver cancer are very encouraging as they show the treatment was generally well-tolerated, with substantial evidence of efficacy. We believe PV-10's ability to selectively target and destroy cancer cells without harming surrounding healthy tissue make it a potentially attractive therapy for cancers of the liver, which can be very serious and difficult to treat if they cannot be fully removed through surgery.”
The Phase 1 study of PV-10 for liver cancer involved six subjects with cancer metastatic to the liver or with recurrent liver cancer. 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 include assessing the distribution and retention of PV-10 in the injected lesion, tumour response and viability, and plasma pharmacokinetics of PV-10 following intralesional injection. In each of two dose cohorts there were three subjects. Dose escalation occurred following assessment of safety and tolerability in the first cohort. Dr Paul Goldfarb, MD, of Sharp Memorial Hospital in San Diego, is the Principal Investigator for the study.
Malignant lesions in the liver arising from primary Hepato-Cellular 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 tumours, particularly those arising in the gastrointestinal tract. Other tumours, such as lung and breast cancer and melanoma, also readily spread to the liver.
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for over thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. 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 calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.
Provectus has completed its phase II clinical trial of PV-10 for metastatic melanoma, and is currently in conversation with both the Food and Drug Administration (FDA) regarding the design of a pivotal phase III randomized controlled trial suitable for SPA (Special Protocol Assessment), and the Australian Therapeutic Goods Administration to review regulatory approval of PV-10 for melanoma in Australia.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects.