Provectus begins phase 1 trial of PV-10 for breast cancer

By Angela McDaniels

Seattle, Dec. 1 - Provectus Pharmaceuticals Inc. said it has begun a phase 1 clinical trial of anti-cancer agent PV-10 (Provecta).

The trial is designed to evaluate the safety and preliminary efficacy of PV-10 in five patients with recurrent breast carcinoma. PV-10 will be injected into one or more tumors in each patient.

After one to three weeks of observation, patients will undergo standard surgery to remove their tumors, allowing thorough assessment of the effects of PV-10 in breast cancer tissue and surrounding normal tissue.

The trial is being conducted in Christchurch, New Zealand, at the Canterbury BreastCare center, a treatment and clinical research center specializing in early studies of new anti-cancer drugs.

Preliminary response data from metastatic melanoma patients undergoing similar treatment with PV-10 have been comparable to that observed in Provectus' preclinical studies of melanoma, breast carcinoma and liver cancer, the company said.

"This trial, running concurrently with our phase 1 trial in Australia of PV-10 for treatment of metastatic melanoma, allows us to characterize the safety and preliminary efficacy of the drug while validating the hypothesis that PV-10 has broad spectrum potential against a wide range of cancers," said Provectus chief executive officer Craig Dees in a company news release.

The company expects to complete the trial in early 2006 and to then begin phase 2 clinical trials for both metastatic melanoma and recurrent breast carcinoma.

PV-10 is an agent that is retained in tumor cells while leaving normal tissue unharmed, thereby killing the tumor and sparing healthy tissue, the company said.

Provectus is a Knoxville, Tenn.-based pharmaceutical company that develops pharmaceutical technologies for the treatment of metastatic melanoma, breast cancer and liver cancer.

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