Provectus Reports Encouraging Clinical Data at ASCO

Objective Response of Treated Lesions Observed in 60% of Subjects

KNOXVILLE, TN (June 1, 2009) /PRNewswire/ — Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has announced interim data from the first 40 subjects in its Phase 2 clinical trial for the treatment of metastatic melanoma. PV-10 treatment was well tolerated and caused selective tumor destruction in the majority of subjects. Additional data on untreated tumors corroborated observations of a possible bystander effect seen during earlier Phase 1 testing. These data were presented today at the American Society of Clinical Oncology 2009 Annual Meeting, Abstract #9060, entitled “Chemoablation of melanoma with intralesional rose bengal (PV-10),” in the General Poster Session.

Key interim data from the first 40 subjects in the Phase 2 study included:

• Objective response of PV-10 treated lesions was observed in 60% of subjects.
• Locoregional disease control of treated lesions was observed in 75% of subjects.
• Response of untreated bystander lesions was consistent with observations from Phase 1 testing.
• Interim safety data were comparable to Phase 1, with transient mild to moderate locoregional pain, vesicles, edema or swelling most common.

“These data provide us much encouragement as they continue to demonstrate how potentially safe and effective PV-10 is for the treatment of metastatic melanoma,” said Dr. Sanjiv Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, who presented the abstract at ASCO. “Particularly positive is further evidence of the ‘bystander effect,’ which appears to induce the patient’s immune system to attack and shrink untreated tumors. Because melanoma often metastasizes in areas of the body that are difficult to treat, such as the head and neck, the ‘bystander effect’ could dramatically improve the prognosis for many patients. We are excited about these results and look forward to continued development of this therapy.”

Dr. Craig Dees, PhD, Chairman and Chief Executive Officer of Provectus said, “The progress we are making in the clinical trials of PV-10 helps pave the way for its possible future as a safe and effective therapy for metastatic melanoma patients. The results presented from the first 40 subjects in the Phase 2 trial bring us another step closer to helping the many thousands of individuals afflicted each year with this insidious disease, whose incidence is rising faster than any other cancer in the U.S. today.”

The American Cancer Society estimates that there are 120,000 patients in the United States with Stage III or Stage IV melanoma, and that 68,000 new cases will be reported in 2009. The World Health Organization reported that it expected 48,000 global deaths in 2008 alone from Stage III or Stage IV melanoma.