First Twenty-Five Percent Of Subjects In Phase 2 Melanoma Clinical Trial Treated

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 09 Jul 2008 - 4:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that the first twenty-five percent (20 of 80) of melanoma subjects have been treated in Provectus Pharmaceuticals' Phase 2 clinical trial of PV-10. Additional subjects are being evaluated for eligibility for entrance into the trial or are awaiting treatment at the two active centers in Brisbane and Sydney, Australia. In addition, Provectus anticipates opening the first United States site for the trial in the very near future. Currently, Provectus is also sponsoring Phase 2 trials for psoriasis and atopic dermatitis in New York and Florida.

"This milestone is significant because as soon as the data for these initial subjects, the first of whom was treated in September 2007, are reviewed a number of potential options on regulatory path may be evident," said Craig Dees, Ph.D., CEO of Provectus. "These could include meeting with regulatory authorities to assess potential for accelerated approval for melanoma based on anticipated results from the full Phase 2 study."

Dees added, "Should the phase 2 trial follow the extraordinary Phase 1 data in terms of efficacy and safety, we would expect to use these data to support a case for potential accelerated approval. However, any such decision affecting the regulatory path would result from extensive consultation between our clinical trials team and the regulatory authorities in those locations that represent important potential markets for PV-10 in melanoma, including the US and Australia."

In Australia, the trials are currently being conducted at the Sydney Melanoma Unit under the supervision of John F Thompson, MD, and at the Princess Alexandra Hospital in Brisbane, Queensland, under Mark Smithers, MD. The Sydney Melanoma Unit is the largest melanoma clinic in the world, with about 1,200 new patients and about 8,000 follow-ups each year. Dr. Thompson has been its Executive Director since 1998.

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.clinicaltrials.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. via the information provided above.

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.