Provectus Pharmaceuticals Inc. Begins Phase 1 Breast Cancer Trial
KNOXVILLE, Tenn., Dec. 1 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. announced today that the first breast cancer patient has completed treatment in the Company's Phase 1 clinical trial of PV-10 (also known as Provecta(TM)). The trial is designed to evaluate the safety and preliminary efficacy of PV-10 in five patients with recurrent breast carcinoma. Each patient enrolled in the study is having PV-10 injected into one or more tumors, which are observed for a period of 1-3 weeks thereafter. The patients then 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 one of the world's leading treatment and clinical research centers specializing in early studies of new anti-cancer drugs. Details of the trial are available from the National Institutes of Health clinical trial database, at http://www.ClinicalTrials.gov .
PV-10 is an agent that is retained in tumor cells while leaving normal tissue unharmed, thereby killing the tumor and sparing healthy tissue. Preliminary response data from metastatic melanoma patients undergoing similar treatment with PV-10 have been comparable to that observed in the Company's preclinical studies of melanoma, breast carcinoma and liver cancer.
Provectus CEO Craig Dees, Ph.D., noted, "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. While these early data are encouraging, it is important to remember that further study will be necessary to definitively demonstrate efficacy."
"We expect our current Phase 1 clinical trials of PV-10 to be completed in early 2006," Dr. Dees added. "We then anticipate initiating Phase 2 clinical trials for both metastatic melanoma and recurrent breast carcinoma."
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals, Inc. is a pioneering pharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of metastatic melanoma, breast cancer and liver cancer. In addition, Provectus is preparing to begin Phase 2 clinical studies for the Company's topical agent Xantryl(TM), a treatment for psoriasis.
The Company's offices and laboratory are located at 7327 Oak Ridge Highway, Suite A, Knoxville, TN 37931; telephone: 865-769-4011. For more information, contact the Company at info@pvct.com or visit the corporate Web site: http://www.pvct.com .
This release and others statements issued or made from time to time by the company or its representatives contain comments that may constitute forward-looking statements. Those include statements regarding the intent, belief or current expectations of the company and members of its management teams, as well as the assumptions on which the statements are based. Prospective investors are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements.
Provectus Pharmaceuticals, Inc.CONTACT: Peter Culpepper, Provectus Pharmaceuticals, Inc.,+1-865-769-4011, or culpepper@pvct.com; or investors, Matt Clawson of Allen& Caron Inc., +1-949-474-4300, or matt@allencaron.com, for Provectus