Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has expanded its compassionate use program for PV-10, making the agent, which is being developed as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients in the United States. The program is already in progress in Australia, where it was initiated in June 2009.
The program for PV-10 is being implemented under the FDA’s guidelines covering compassionate use of an investigational new drug. The U.S. program commenced at St. Luke’s Hospital & Health Network in Bethlehem, PA, under the direction of Dr. Sanjiv Agarwala, Principal Investigator at that site for Provectus’ Phase 2 melanoma trial. As in Australia, PV-10 will only be available for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers and melanoma. Interested parties are encouraged to visit Provectus’ website, www.pvct.com, where details on the compassionate use program and additional information will be posted in the near future. Compassionate use programs provide patients with access to experimental therapeutics prior to final FDA approval. Provectus expects to expand the compassionate use program to other sites in the United States in coming months.
Dr. Kelly McMasters, a preeminent physician and investigator who is a member of Provectus’ Board of Directors and head of its Scientific Advisory Board, will continue his role as advisor to the Company on candidates for the program who might be safely helped by PV-10. Dr. McMasters said, “Commencement of the compassionate use program in the United States is timely, given the fact that all patients in the Phase 2 trial for metastatic melanoma have now been treated. Interim results from the Phase 2 trial demonstrate that PV-10 is well-tolerated, eliciting a robust response in a majority of patients, with a safety and efficacy profile that compares favorably with existing and emerging therapies. These factors, along with completion of Phase 1 clinical testing of PV-10 for treatment of recurrent breast cancer, are strong reasons to make PV-10 available on a compassionate use basis.”
Craig Dees, Ph.D., CEO of Provectus said, “We have received many requests from physicians to make PV-10 available to their patients on a compassionate use basis. Considering the encouraging interim results we have received from Phase 2 testing of PV-10, enabling patients access to the drug via a compassionate use program is absolutely the right thing to do. We believe that PV-10 has the potential to be effective for several indications, and are pleased to be able to offer it in the United States and Australia through this program. In the meantime, our developmental efforts continue for PV-10, and we look forward to continued progress.”
Provectus Pharmaceuticals, Inc.