Metastatic Melanoma - Provectus Adds 6th Center To Phase 2 Clinical Trial Of PV-10

Main Category: Cancer / Oncology
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 19 Nov 2008 - 8:00 PST

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has begun recruitment for its Phase 2 clinical trial of the Company's lead oncology agent PV-10 at a sixth major center located at the California Pacific Medical Center, in San Francisco, CA. David Minor, M.D. will serve as principal investigator at the new center covering the western United States.

This sixth site is in addition to Sydney, Brisbane and Adelaide in Australia, as well as M.D. Anderson in Houston, Texas, and St. Luke's Hospital & Health Network, in Bethlehem, PA. Over the next several months, the Company expects to continue expansion of the study to include sites in other major population centers in Australia as well as at least one more site in the United States.

Phase 2 clinical testing of PV-10 is designed to assess the agent as a treatment for Stage III and IV metastatic melanoma, the most aggressive and deadly form of skin cancer. The multi-center study will evaluate efficacy of PV-10 in a total of 80 subjects. In the study, PV-10 is being injected into up to 20 tumors in each subject. Additional treatment with PV-10 may be made 8 to 16 weeks after this initial injection, if deemed necessary by the investigator. Response will be observed for one (1) year, allowing data to be gathered for assessment of objective response rate, progression free survival, quality of life and safety. An interim assessment of safety and efficacy will be conducted after treatment of the first 20 and first 40 subjects. Details of the study are available at the http://www.ClincalTrials.gov clinical trials registry.

"Opening the center in San Francisco is a logical continuation of our expansion of our Phase 2 program in melanoma to multiple sites including the U.S.," said Craig Dees, Ph.D., CEO of Provectus. "It is another important step in our effort to get the treatment available to as many patients as possible in the shortest possible time."

Provectus recently announced that enrollment is nearing the halfway point in the study. Further update on study status is planned for the Clinical Oncology Society of Australia (COSA) meeting, November 19, 2008 in Sydney, Australia, where Professor John F. Thompson, MD, will review Phase 1 results and interim safety data from the first 20 subjects in the Phase 2 study.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company's other clinical trials can be found at the NIH registry, http://www.ClincalTrials.gov. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. For additional information about Provectus please visit the Company's website at http://www.pvct.com or contact Porter, LeVay & Rose, Inc.

Forward-Looking Statements

The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc.