Provectus Pharmaceuticals Inc has achieved FDA clearance of its Investigational New Drug Application (IND) for Provecta -a small-molecule, tumour-specific agent designed to treat breast, liver, prostate and other potentially deadly cancers. Provectus announced submission of this application in late August.

Upon initial filing of an IND, the US FDA imposes a thirty-day review period prior to initiation of human clinical studies. This allows the FDA to identify deficiencies in the application that require correction before human studies begin and to issue a "clinical hold" until such deficiencies are corrected. This review period has passed without notification of such deficiencies, signifying that Provectus may begin human studies on Provecta, according to a company release.

Provecta is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential side effects. Provectus expects to begin enrolling patients with localized recurrent breast tumours in clinical trials beginning early 2005.

"As we begin final preparations for our first clinical studies of Provecta, we are optimistic that the drug may play an important role in combating this serious disease that kills thousands of women each year," said Provectus CEO Craig Dees, "Since Provecta has specifically targeted and destroyed a broad spectrum of human breast tumours in our preclinical studies, we expect that it will exhibit similar performance when used against tumours in humans," he added later.

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