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Provectus Pharmaceuticals, Inc. Completes
Dosing of Patients in Phase 1 Melanoma Study
Tuesday April 24, 2007
Announces Successful Attainment of the Study Objectives
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT - News) has
successfully completed dosing in the final patient enrolled in its Phase 1 study of PV-10 for use on Stage
III/IV metastatic melanoma. PV-10 is the company's proprietary drug being tested for treatment of metastatic
melanoma, breast cancer and liver cancer.
Craig Dees, Ph.D., Chief Executive Officer of Provectus stated "We are happy to announce that the endpoints
of this study of the safety and preliminary effectiveness of PV-10 appear to have been met. While it will be
several months before final follow-up is completed for the last patient, PV-10 was generally well tolerated by
all 20 patients with minimal side effects. Furthermore, interim analysis of final data from the first 11 patients
indicates that the rate of response for a single injection of their tumors with PV-10 was at least several times
greater than that typically achieved using the standard drugs administered to patients in the U.S. Even though
the drug is administered by direct injection into an individual tumor, a number of patients displayed evidence
that non-injected tumors responded as well. The presence of this 'bystander effect' is significant because it
demonstrates that PV-10 likely triggers systemic anti-tumor activity. Demonstration of systemic activity is
critical in improving patient outcomes."
Current drug therapies for metastatic melanoma include systemic use of interferon-alpha and the
chemotherapeutic agent DTIC. Both require repeat dosing over a period of weeks to months or longer, have
significant side effects, and have exhibited a response rate of less than 20% in clinical trials.
Dees noted, "PV-10 differs dramatically from these conventional therapies in several key ways. First, PV-10
is injected only into the tumor itself, causing cell death and the release of large amounts of tumor antigen.
Second, the resulting destruction of the injected tumors appears to elicit an anti-tumor immune response, the
so called 'bystander effect,' that can lead to spontaneous regression of untreated tumors. For patients with
metastatic disease, this may mean improved outcome in both their treated tumors and in metastases elsewhere
that cannot be easily treated, or have yet to be detected."
"With this critical study essentially complete, we are making final preparations to begin the next round of
testing intended to definitively demonstrate efficacy of PV-10. We expect to begin this study within several
months, treating up to 80 Stage III/IV melanoma patients at seven or more sites in Australia and the U.S. We
will follow their response for 12 months to allow us to gauge both local response in their treated tumors and
their longer-term outcome."
The company expects to release detailed results from the Phase 1 study throughout the year as final follow-up
is completed for all subjects.
About Provectus Pharmaceuticals, Inc.
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Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies that are safer, more
effective, less invasive and more economical than conventional therapies. Provectus takes a macroscopic, or
"big picture", approach by applying small-molecule drugs that target diseased tissue, allowing the therapy to
selectively attack broad classes of disease. This opposes current industry trends that take a molecular
(microscopic) approach. Provectus is currently conducting clinical trials of their proprietary drugs PV-10 as a
therapy for melanoma and breast cancer, as well as PH-10, a topical treatment for severe psoriasis and
eczema. The company expects to commence Phase 2 clinical testing of PV-10 for melanoma in the near
future. Further, use of PV-10 for melanoma has received orphan drug designation from the FDA. Initial Phase
1 clinical trial objectives for PV-10 for breast cancer were completed in April 2006, but the trial was extended
to more properly determine optimal dosing. The extended Phase 1 trial is also nearing completion and the
company anticipates reporting those results in the near future. Additionally, the company is about to begin
Phase 2 of clinical testing for PH-10 for psoriasis. Complementing their suite of proprietary drugs, Provectus
has developed a number of intellectual properties and technologies in the areas of medical devices and
biotechnology. For additional information about Provectus please visit the company's website at
www.pvct.com or contact The Investor Relations Group via the information provided below.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to
certain risks and uncertainties that could cause actual results to differ materially from those reflected in the
forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking
statements, which reflect management's analysis only as of the date hereof. The company undertakes no
obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise
after the date thereof.
Contact:
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, 865-769-4011
or
The Investor Relations Group
Investor Relations:
Joseph Kessler
or
Media:
Janet Vasquez
212-825-3210
Source: Provectus Pharmaceuticals, Inc.
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