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.