Leading Melanoma Specialist Validates Ablative Ability And Systemic Effects Of Provectus Anti-Cancer Agent PV-10

Main Category: Cancer / Oncology
Also Included In: Melanoma / Skin Cancer;  Clinical Trials / Drug Trials
Article Date: 15 Sep 2006 - 0:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT) announced today that Professor Peter Hersey, M.D., presented results at the Third Annual International Melanoma Research Congress, September 14-16, 2006, in Noordwijk, The Netherlands that outlined how the Company's leading anti-cancer agent, PV-10, completely ablated a cluster of metastatic melanoma tumors afflicting a clinical trial participant. Hersey, an oncologist and leading international authority on melanoma, noted that treatment of one of the tumors with PV-10 led to complete eradication of all four tumors that had repeatedly resisted treatment with surgery, chemotherapy and radiation therapy.

"Without this treatment this man would have probably survived only a few months," noted Hersey, a professor of oncology at the University of Newcastle, Medical and Research Director of the Newcastle Melanoma Unit and a 14-year member of the World Health Organization's Committee on Melanoma.

"He had multiple reoccurrences in the previously treated area of his face and nothing was helping him. I'm happy to say he is home, happily enjoying his later years."

The 86 year old is part of a 20-subject Phase 1 study of the safety and efficacy of PV-10, an injectable formulation of Rose Bengal also known as Provecta(TM), for the ablation of metastatic melanoma, an aggressive and often fatal form of skin cancer. The peer-reviewed abstract of Hersey's presentation is expected to be published in Melanoma Research ( http://www.melanomaresearch.com ) in the coming weeks. The full presentation may be found on the Company's website (http://www.pvct.com/RoseBengalPresentation.pdf).

Professor Hersey characterized the results achieved through PV-10 as remarkable, particularly because of the apparent systemic effects of the agent. While further study is needed, Hersey said that PV-10 ablation of the treated tumor appeared to elicit an immune response leading to destruction of untreated cancerous tumors, a response often called the bystander effect, while leaving healthy tissue intact.

"We may have found an Achilles heel of these tumors," Professor Hersey stated. "Many who were originally skeptical now believe we have something here. PV-10 appears to function by a novel mechanism that selectively targets the lysosomes of cancer cells, leading to rapid necrosis of treated tumors. This results in destruction of the tumors and may explain its systemic effects. Hence, PV-10 may represent an important new category of oncology agent. Whether it is a major breakthrough in cancer treatment deserves further study. But we have already seen some very impressive responses."

The clinical trial of PV-10 is being conducted at two of the world's leading melanoma treatment and research centers, the Sydney Melanoma Unit and the Newcastle Melanoma Unit, both located in New South Wales, Australia, a country where the incidence of melanoma is more than twice that of the United States. Each subject enrolled in the study has one or more tumors treated with a single injection of PV-10 and the local response to the treatment is then observed for a period of 12 to 24 weeks. More details of the study are available at http://www.ClinicalTrials.gov (study PV-10-MM-01).

Pre-clinical animal studies have shown broad-spectrum applicability of the agent for selective ablation of a number of cancers, including melanoma, breast carcinoma, and hepatocellular carcinoma.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals, Inc. is an innovative biopharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of breast cancer, liver cancer, and metastatic melanoma. In addition, Provectus is preparing to begin Phase 2 clinical studies for the Company's topical agent Xantryl(TM), a treatment for psoriasis.

Provectus Pharmaceuticals, Inc.
http://www.pvct.com

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