Provectus Completes Initial Phase 1 Metastatic Melanoma Clinical Trial Objectives

Main Category: Melanoma / Skin Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 16 May 2006 - 0:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT) announced today that a second group of subjects has been treated in the Company's Phase 1 clinical trial of PV-10 (also known as Provecta(TM)) for ablation of metastatic melanoma, an aggressive and often fatal form of skin cancer. Treatment with PV-10 was well tolerated by all subjects, with no evidence of systemic o serious local side effects. Most subjects have exhibited evidence of efficacy, ranging from tumor shrinkage to complete ablation. Several also exhibited subsequent shrinkage of untreated tumors, a response characteristic of the "bystander effect." These results achieve the primary study endpoints of safety and preliminary efficacy assessment.

The Phase 1 study consists of 20 subjects, and is being conducted at two of the world's leading melanoma treatment and research centers, the Sydney Melanoma Unit and the Newcastle Melanoma Unit, both located in New South Wales, Australia, a country where the incidence of melanoma is more than twice that of the United States. Each subject enrolled in the study has one or more tumors treated with a single injection of PV-10 and the local response to the treatment is then observed for a period of 12 to 24 weeks. Any effects on nearby untreated tumors (called the bystander effect) are also monitored. Details of the study design are available at http://www.ClinicalTrials.gov (study PV-10-MM-01).

Based on these promising results, the Company has expanded the scope of the study to include a third group of subjects who will receive treatment of up to 20 melanoma lesions. The maximum lesion diameter will also be doubled and study eligibility expanded to include Stage IV subjects (those who have distant metastases). These changes will allow the Company to further assess performance of PV-10 and validate anticipated Phase 2/3 study design parameters where all accessible lesions are expected to be treated.

"We are enthusiastic to continue our studies with PV-10, and the possibility that the agent has some potential to treat systemic disease is interesting," noted Professor John Thompson, MD, director of the Sydney Melanoma Unit and a principal investigator for the study. "Clearly we need to do more work to fully assess its value in control of metastatic disease."

PV-10 is an agent that is retained in tumor tissue while leaving normal tissue unharmed, thereby killing the tumor and sparing healthy tissue. Pre- clinical animal studies have shown broad-spectrum applicability of the agent for selective ablation of a number of focal cancers, including melanoma, breast carcinoma, and hepatocellular carcinoma.

"The data from Australia make us very optimistic about the prospects for PV-10 in ablation of metastatic melanoma," noted Provectus CEO Craig Dees, PhD. "Along with our progress in New Zealand, where we are studying use of PV- 10 for ablation of recurrent breast tumors, we are especially pleased with the apparent specificity of the drug for cancerous tissue."

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals, Inc. is an innovative biopharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of breast cancer, liver cancer, and metastatic melanoma. In addition, Provectus is preparing to begin Phase 2 clinical studies for the Company's topical agent Xantryl(TM), a treatment for psoriasis.

Provectus Pharmaceuticals, Inc.
http://www.pvct.com

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