Compassionate Use Program for PV-10

Compassionate use programs provide experimental therapeutics to patients prior to final FDA approval. Initially, the compassionate use program for 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. Provectus began its compassionate use program for PV-10 in certain Australian "Centers of Excellence," including Sydney, Brisbane and Adelaide, and has now started expanding it to the United States. The program is currently active at six sites:

• St. Luke's Hospital and Health Network, Bethlehem, PA;
• M.D. Anderson Cancer Center, Houston, TX;
• University of Louisville, Louisville, KY;
• Melanoma Institute Australia, Sydney, Australia;
• Princess Alexandra Hospital, Brisbane, Australia; and
• Royal Adelaide Hospital, Adelaide, Australia.

The Australian program is under the guidelines of the Therapeutic Goods Administration's Special Access Scheme, while the U.S. program is under the FDA's regulations covering Treatment Use of an Investigational New Drug.

Information about this expanded access study, titled "Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors", is available at the U.S. National Institute of Health's ClinicalTrials.gov website.

Additional information on the Compassionate Use Program for PV-10 will be posted here as it becomes available. Interested parties are encouraged to contact Peter Culpepper at:

E-mail: culpepper@pvct.com