Provectus PV-10 Interim Phase 2 Safety And Efficacy Results Are As Good As Or Better Than Phase 1 Results

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 17 Mar 2009 - 0:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced that the interim safety and efficacy results from the first 20 subjects in its Phase 2 clinical trial for the treatment of metastatic melanoma are as good as or better than Phase 1 data. Additionally, extended Phase 1 survival data was reported.

The lead investigator for Provectus' Phase 2 study of PV-10 for metastatic melanoma, Professor John F Thompson, MD, presented the update on Provectus' development efforts at The Sixth International Symposium on Melanoma and Other Cutaneous Malignancies on March 13, 2009 in New York City. A detailed analysis of the interim Phase 2 study results will be made available at the 2009 American Society of Clinical Oncology (ASCO) Scientific Program on May 29 - June 2, 2009 in Orlando, Florida."

Commenting on extended long-term survival data now available for subjects who participated in the Phase 1 study, Thompson noted, "There was an improvement in survival for those subjects achieving an objective response of their injected lesions, with a mean survival of 34.8 months as of early March, compared with a mean survival of 29.7 months calculated in October 2008. These results are even more interesting when one looks at disease-specific survival, where the mean for the response-positive group has increased to 37.3 months. This indicates that response of treated lesions may be a good predictor of long-term outcome."

Professor Thompson added, "The interim Phase 2 results are also very encouraging, with efficacy and safety as good as or better than those results reported for Phase 1. With the Phase 2 protocol allowing us to treat lesions more than once, we are pleased to report results that are in line with what our expectations have been."

Dr. Craig Dees, PhD, CEO of Provectus concluded, "We are encouraged by these Phase 2 interim results as well as by the improved long-term survival data from Phase 1. With the American Cancer Society estimating that approximately 120,000 patients in the U.S. alone have metastatic melanoma, and the World Health Organization reporting that about 48,000 patients died around the globe from melanoma in 2008, clearly there is a need for a new safe and effective treatment for metastatic melanoma. We look forward to furthering this important research on PV-10 and to communicating detailed Phase 2 interim results at ASCO."

About PV-10

PV-10 is based on a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly fifty years by ophthalmologists and optometrists to assess damage to the eye. It has also been used to detect ailments of the liver. Rose Bengal has an established safety history, a short half-life, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

About The Sixth International Symposium on Melanoma and Other Cutaneous Malignancies

The Sixth International Symposium on Melanoma and Other Cutaneous Malignancies, an Oncology CME-Certified Symposium, focused on therapeutic benefit from several novel agents that target key cellular systems involved in the progression of melanoma or other cutaneous diseases. This interactive symposium also emphasized issues concerning surgical management, adjuvant therapy, advanced disease therapy, and personalizing the course of treatment for individual patients. Data was also presented on important clinical trials of novel therapeutic regimens in the adjuvant and advanced disease settings currently recruiting patients with melanoma and other cutaneous malignancies. In addition, the Intralesional Therapy for Melanoma: Two Steps Forward and One Step Back? Satellite Symposium, which included discussion on "Investigating Local Control Strategies: The Case for Intralesional Therapy-Emerging Approaches to Intralesional Therapy" focused on intralesional therapy as a strategy for both local and potentially systemic control of melanoma.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of its proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company's other clinical trials can be found at the NIH registry, http://www.clinicaltrials.gov. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. For additional information about Provectus please visit the Company's website at http://www.pvct.com or contact Porter, LeVay & Rose, Inc.

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.

Provectus Pharmaceuticals
http://www.pvct.com

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