KNOXVILLE, Tenn., April 27 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. announced today that all subjects have been treated in its initial Phase 1 clinical trial of PV-10 (also known as Provecta(TM)) for ablation of recurrent breast cancer. Treatment with PV-10 was well tolerated by all five subjects, with no evidence of systemic or serious local side effects. Several subjects exhibited evidence of efficacy, including tumor ablation or shrinkage. These results achieve the primary study endpoints of safety and preliminary efficacy assessment.
Follow-up of four of the five subjects has been completed with follow up of the final subject expected to be completed in May. Details of the study design are available at www.ClinicalTrials.gov (study PV-10-BC-04).
Based on the promising results of the initial Phase 1 trial, the Company is expanding the study to include two additional dose groups (five subjects per group) that will receive progressively higher doses of PV-10. The expanded study is designed to identify the appropriate dose of PV-10 for Phase 2/3 studies and is expected to begin immediately upon receipt of regulatory approval.
“The study has progressed successfully and the safety and preliminary efficacy results are very encouraging,” noted Chris Wynne, MD., who is located in Christchurch, New Zealand and is the principal investigator for the study. “The demonstrated safety and response data warranted expansion of the study to include ascending dose groups to define the optimal efficacy dose for advanced studies.”
PV-10 is an agent that is retained in tumor cells while leaving normal tissue unharmed, thereby killing the tumor cells 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 breast carcinoma, melanoma, and hepatocellular carcinoma.
“The results observed in our New Zealand breast carcinoma trial are consistent with our pre-clinical animal model data and, perhaps more importantly, with initial results observed in Australia for ablation of metastatic melanoma,” noted Provectus CEO Craig Dees, PhD. “Together, these data show that PV-10 can yield dramatic, rapid tumor destruction with no significant effects in the surrounding normal tissue. We are especially pleased by its similar response in such difficult and different manifestations of cancer.”
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.
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: investors, Matt Clawson of Allen & Caron Inc., +1-949-474-4300,or matt@allencaron.com, for Provectus Pharmaceuticals, Inc.; or PeterCulpepper of Provectus Pharmaceuticals Inc., +1-865-769-4011, orculpepper@pvct.com
Web site: http://www.pvct.com//
