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Investigational New Drug Application Filed for Provecta, Treatment of Solid Tumors

KNOXVILLE, Tenn., Aug. 25 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. (BULLETIN BOARD: PVCT) announced today it has filed an Investigational New Drug (IND) application for Provecta™, an advanced drug therapy designed to treat breast, liver, prostate and other potentially deadly cancers. If the U.S. Food & Drug Administration accepts the application, Provectus expects to begin enrolling patients in clinical trials beginning early 2005.

Provectus has completed a full range of successful preclinical studies in laboratory models. When injected into tumor tissue, Provecta™ concentrates in the tumor and then quickly dissipates from surrounding, healthy tissue. This characteristic makes the drug potentially safer and more effective than conventional therapies.

Related preclinical studies using Provecta™ as a radiosensitizer currently are underway at the University of Wisconsin-Madison. Because Provecta™ increases the effects of radiation on tumor tissue, substantially less radiation may be needed, thereby subjecting patients to fewer side effects. Additionally, Provecta™ has been used to treat a number of spontaneous tumors in veterinary subjects.

"Provecta's major advantage over current therapies is that it is a small molecule that specifically targets only diseased tissue, thereby increasing its potency against tumors," said Provectus CEO Craig Dees, Ph.D. "We believe this unique feature may result in rapid allowance of the IND and, eventually, Fast Track consideration by the FDA."

"Besides the advantage this major step will provide to Provectus Pharmaceuticals as a company, it is also very satisfying to see this drug move forward in fulfilling its potential to help people who are gravely ill," said Eric Wachter, Ph.D., senior vice president of Provectus and co-inventor of the cancer therapy.

Source: Provectus Pharmaceuticals, Inc.

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