PV-10 Treatment For Metastatic Melanoma Well-Tolerated By Patients - Evidence Of "Bystander Effect" Observed In Phase 1 Trial

Main Category: Cancer / Oncology
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 06 Oct 2008 - 0:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced that the lead investigator for its Phase 2 melanoma study, Professor John F Thompson, MD, today presented clinical data on PV-10 at the "Perspectives in Melanoma XII" meeting at The Hague, The Netherlands. Professor Thompson's presentation was entitled "PV-10 Chemoablation of cutaneous and subcutaneous metastatic melanoma." Craig Dees, PhD, CEO of Provectus, said, "Our Company is engaged in opening a new front in the war on cancer, and the clinical studies led by Professor Thompson are a major component of that new front. Our phase 1 trial was a great success, and initial results we have from our ongoing phase 2 trial are encouraging."

According to the Phase 1 data presented, PV-10 treatment was well tolerated despite the relatively advanced age of the subjects. In addition, PV-10 appeared to trigger a response in the immune system of a number of subjects, enabling their bodies to attack uninjected melanoma tumors in a process called the 'bystander effect'.

PV-10 is a solution of Rose Bengal (10% RB in saline) that Professor Thompson has been using to treat metastatic melanoma. In the phase 1 study, safety and preliminary efficacy were assessed in 20 subjects with Stage III or IV metastatic melanoma, either on the skin or just beneath it. All subjects received a single treatment of up to 20 lesions, while up to 3 untreated lesions were observed for evidence of the potential bystander effect.

When injected into melanoma tumors, PV-10 appeared to kill the tumors by a process called chemoablation while leaving surrounding healthy tissue undamaged. Thompson found that injected tumors started to die within several days. Complete or partial response was characterized by gradual involution, or shrinking, that appeared to continue for up to 12 weeks or more. Forty percent of subjects achieved an objective response in their injected lesions, with 20% having a complete response (CR) and another 20% having a partial response (PR). An additional 35% experienced stable disease (SD).

Sixteen subjects (80%) completed the minimum 12 weeks of observation, while four withdrew early due to underlying disease progression. The most common adverse events were transient pain at the treatment site (75% of subjects), followed by local inflammation or mild infection (25% of subjects). Only three systemic adverse events were reported (a single instance each of mild insomnia secondary to injection site pain, mild photosensitivity reaction restricted to the injected limb, and Grade 3 photosensitivity reaction).

The expanded phase 2 testing for PV-10 commenced in late 2007, aiming to assess PV-10 chemoablation in 80 Stage III and IV metastatic melanoma subjects - the same condition as in the phase 1 study. Over one third of the patients needed have already been enrolled at centers in Brisbane and Sydney, Australia, and at the M.D. Anderson Cancer Center in Houston, TX. Provectus expects to announce further sites in the U.S. and Australia in the near future. This phase 2 study differs from phase 1 testing in several key ways: new or incompletely responsive lesions may be treated at weeks 8, 12 or 16 after initial PV-10 administration; and follow-up is extended to 52 weeks.

According to the American Cancer Society, more than 62,000 people are expected to be diagnosed in the in the US in 2008 with melanoma, the most serious form of skin cancer, leading over 8,000 deaths this year.

About Perspectives in Melanoma XII

With a wealth of new data in a rapidly evolving field, Perspectives in Melanoma XII is designed to provide a comprehensive overview of recent advances and rigorous discussions of the most current and controversial topics in melanoma clinical research and contemporary therapy. Led by authorities and current investigators in the field, the program covers several of the most promising and important on-going clinical trials. State-of-the-art presentations by experts in molecular biology, genetics, and immunology are designed to provide an educational experience for all melanoma-related disciplines.

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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 their 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, Inc