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First Melanoma Patients Complete Treatment in Provectus Phase 1 Clinical Trial of PV-10

Posted on: Monday, 8 August 2005, 12:01 CDT

KNOXVILLE, Tenn., Aug. 8 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. (BULLETIN BOARD: PVCT) announced today that the first patients have completed treatment in its Phase 1 clinical trial of PV-10, also known as Provecta(TM). PV-10 is the Company's lead cancer agent and is being evaluated for safety and preliminary efficacy in 20 subjects with Stage III metastatic melanoma, which is the most aggressive form of skin cancer. The study is being conducted at two of the world's leading melanoma treatment and research centers, both located in New South Wales, Australia, a country where the incidence of melanoma is more than twice that of the United States.

Each patient enrolled in the study is having one to three tumors treated with a single injection of PV-10 and the local response to the treatment is then being observed for a period of 12 to 24 weeks. Potential effects on nearby untreated tumors (called a "bystander effect") will also be monitored. It is anticipated that the full study will be finished early next year.

Biotechnology entrepreneur and consultant David M. Darst, a member of the Provectus Corporate Advisory Board, said, "The initiation of PV-10's first Phase 1 clinical trial is very positive news, especially since the trial has the potential to show statistically significant efficacy in addition to a safety profile. The PV-10 trial has a well designed protocol and is being conducted in collaboration with leading clinical investigators. Most importantly, the results could suggest a potentially exciting new treatment option for metastatic melanoma patients, although additional studies will be required to confirm this."

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals, Inc. is a pioneering pharmaceutical 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.

The Company's offices and laboratory are located at 7327 Oak Ridge Highway, Suite A, Knoxville, TN 37931; telephone: 865 769 4011. For more information, contact the Company at info@pvct.com or visit the corporate Web site: http://www.pvct.com/.

This release and others statements issued or made from time to time by the company or its representatives contain comments that may constitute forward- looking statements. Those include statements regarding the intent, belief or current expectations of the company and members of its management teams, as well as the assumptions on which the statements are based. Prospective investors are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward- looking statements.

Provectus Pharmaceuticals, Inc.

CONTACT: Matt Clawson (investors) of Allen & Caron Inc, +1-949-474-4300,matt@allencaron.com, or Peter Culpepper of Provectus Pharmaceuticals, Inc.,+1-865-769-4011, culpepper@pvct.com

Web site: http://www.pvct.com/


Source: PRNewswire-FirstCall

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