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10-06-2005, 06:00 PM
Provectus Pharmaceuticals, Inc. announced today that it has obtained final clearance to begin its second Phase 1 clinical trial of PV-10 (also known as Provecta™), the Company's lead cancer treatment. The study is designed to evaluate the safety and preliminary efficacy of PV-10 in five subjects with recurrent breast carcinoma. PV-10 will be injected into one or more tumors in each subject, and the local response to this single injection observed for a period of 1-3 weeks thereafter. Subjects will then undergo standard surgery to remove their tumors, allowing study personnel to carefully assess the effects of PV-10 in breast cancer tissue and surrounding normal tissue.
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The study will be conducted in Christchurch, New Zealand, at one of the world's leading treatment and research centers specializing in early studies of new anti-cancer drugs. Clearance has been received upon review of the study by the institution's regional ethics committee and by MedSafe, the New Zealand federal agency responsible for regulation of clinical studies and therapeutic goods. Subject enrollment and treatment is expected to begin immediately. Details of the study are expected to be available in the near future at the National Institutes of Health clinical trial database website, at http://www.ClinicalTrials.gov (http://www.clinicaltrials.gov/).
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. Initial clinical response in melanoma subjects appears to be similar to that noted in the Company's preclinical studies of melanoma, breast carcinoma, and liver cancer.
Provectus CEO Craig Dees, Ph.D., noted, "This second Phase 1 study, running in parallel with our ongoing study in Australia of PV-10 for treatment metastatic melanoma, will allow us to further characterize the safety and preliminary efficacy of the drug. Perhaps more importantly, it should allow us to rapidly validate the hypothesis that PV-10 has broad spectrum potential against a wide range of cancers."
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 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™, 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 (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.
CONTACT: Matt Clawson (investors) of Allen & Caron Inc, +1-949-474-4300,matt@allencaron.com; or Peter Culpepper of Provectus Pharmaceuticals Inc.,+1-865-769-4011, culpepper@pvct.com
Web site: http://www.pvct.com/ (http://www.pvct.com/) http://www.ClinicalTrials.gov/ (http://www.clinicaltrials.gov/)
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The study will be conducted in Christchurch, New Zealand, at one of the world's leading treatment and research centers specializing in early studies of new anti-cancer drugs. Clearance has been received upon review of the study by the institution's regional ethics committee and by MedSafe, the New Zealand federal agency responsible for regulation of clinical studies and therapeutic goods. Subject enrollment and treatment is expected to begin immediately. Details of the study are expected to be available in the near future at the National Institutes of Health clinical trial database website, at http://www.ClinicalTrials.gov (http://www.clinicaltrials.gov/).
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. Initial clinical response in melanoma subjects appears to be similar to that noted in the Company's preclinical studies of melanoma, breast carcinoma, and liver cancer.
Provectus CEO Craig Dees, Ph.D., noted, "This second Phase 1 study, running in parallel with our ongoing study in Australia of PV-10 for treatment metastatic melanoma, will allow us to further characterize the safety and preliminary efficacy of the drug. Perhaps more importantly, it should allow us to rapidly validate the hypothesis that PV-10 has broad spectrum potential against a wide range of cancers."
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 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™, 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 (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.
CONTACT: Matt Clawson (investors) of Allen & Caron Inc, +1-949-474-4300,matt@allencaron.com; or Peter Culpepper of Provectus Pharmaceuticals Inc.,+1-865-769-4011, culpepper@pvct.com
Web site: http://www.pvct.com/ (http://www.pvct.com/) http://www.ClinicalTrials.gov/ (http://www.clinicaltrials.gov/)