Provectus Pharmaceuticals Inc 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 US 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 tumour tissue, Provecta concentrates in the tumour and then quickly dissipates from surrounding, healthy tissue. This characteristic makes the drug potentially safer and more effective than conventional therapies, a company release said.

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 tumour 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 tumours 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 tumours," said Provectus CEO Craig Dees. "We believe this unique feature may result in rapid allowance of the IND and, eventually, Fast Track consideration by the FDA," he added.

"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, senior vice president of Provectus and co-inventor of the cancer therapy.

Provectus Pharmaceuticals Inc is a pharmaceutical company actively engaged in the design, development and marketing of a diverse portfolio of leading pharmaceutical technologies for the treatment of liver, breast and prostate cancer.