Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical trial of PV-10 for metastatic melanoma. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma.
Dr. Craig Dees, PhD, CEO of Provectus said, “Completing this portion of the Phase 2 trial of PV-10 for metastatic melanoma is an important milestone in our efforts to develop a new treatment alternative for this horrendous disease. With compelling interim data presented at the American Society of Clinical Oncology (ASCO) a few months ago, completing this phase of the study furthers our PV-10 development efforts. As we prepare to seek additional guidance from the FDA regarding the actions we need to take to obtain approval for this treatment, we are concurrently taking steps to either seek licensure agreements and/or partnerships that would facilitate final development of this novel oncology drug. We believe PV-10 is a promising therapy that could be of great value to our company and our potential partners.”
“We look forward to providing interim results to our shareholders and the medical community as we complete the analysis of the 80 patients in this trial,” he concluded.
The primary objective of the Phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions. Additional objectives of the trial are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. The Phase 2 study is an interventional, open-label, multicenter, single group assignment safety/efficacy study. To accurately reflect anticipated clinical use, repeat dosing of lesions not exhibiting complete response was allowed at the investigator’s discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10. The estimated primary completion date for this trial is May 2010, with an estimated study completion date of July 2010.