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Provectus Cancer Treatment Well Tolerated By Patients at Initial Dose in Phase 1 Clinical Trial of PV-10

Posted on: Wednesday, 17 August 2005, 09:00 CDT

KNOXVILLE, Tenn., Aug. 17 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. (BULLETIN BOARD: PVCT) announced today that the first group of subjects have completed treatment in its Phase 1 clinical trial of PV-10, also known as Provecta(TM), and that the treatment was well tolerated at the initial lower dose level. The study is being conducted at two dosage levels with both dosage levels having the potential for showing safety, preliminary efficacy, and the "bystander effect." The authorized dosage will now be increased to the maximum level for treatment of the remaining subjects.

PV-10 is the Company's lead cancer agent and is being evaluated for safety and preliminary efficacy in a total of 20 subjects with Stage III metastatic melanoma, which is the most aggressive form of skin cancer. The study is being conducted at two of the world's leading melanoma treatment and research centers, 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 is having one to three tumors treated with a single injection of PV-10 and the local response to the treatment is then being observed for a period of 12 to 24 weeks. Potential effects on nearby untreated tumors (called a "bystander effect") will also be monitored.

Eric Wachter, Ph.D., Executive Vice President and head of the Company's pharmaceutical development program, noted, "The initial data is very encouraging and appears comparable to the response we've seen in each of our preclinical studies. While this is exciting, it is important to remember that even if this study proves to be successful, further study will be necessary to definitively demonstrate efficacy."

Provectus CEO, Craig Dees, Ph.D., noted, "Given the extensive safety record of the active ingredient of PV-10 in other human applications, we fully expected patients to tolerate the drug well. Nonetheless, we are extremely pleased to have crossed this important threshold in our first oncology clinical trial, paving the way for timely completion of the study by early next year and initiation of our planned companion study of PV-10 for treatment of recurrent breast carcinoma later this year."

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(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, Allen & Caron Inc., +1-949-474-4300,matt@allencaron.com; Peter Culpepper of Provectus Pharmaceuticals Inc.,+1-865-769-4011 or culpepper@pvct.com

Web site: http://www.pvct.com/

Source: PRNewswire-FirstCall

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