KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has completed patient accrual and initial PV-10 treatment in its Phase 2 trial of PV-10 for metastatic melanoma. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma.
Dr. Craig Dees, PhD, CEO of Provectus said, "It is gratifying to have reached our patient enrollment objective in the Phase 2 trial of PV-10 for metastatic melanoma and we are pleased with the interim efficacy and safety results that have been achieved and reported on the first 20 patients enrolled in the trial. Completion of the enrollment phase of the trial brings us another step closer in our efforts to find a treatment that may help the estimated 120,000 patients in the U.S. alone who are afflicted with this devastating disease. With an estimated 48,000 global deaths having occurred last year from Stage III or Stage IV melanoma, we remain focused on furthering our work aimed at developing a safe and effective treatment. We look forward to communicating detailed Phase 2 interim results at the American Society of Clinical Oncology (ASCO) Scientific Program on June 1, 2009 in Orlando, Florida."
He continued, "Also noteworthy is that even though this phase of the trials has concluded, our investigators have requested that they be allowed to treat more patients. Therefore, we are implementing a compassionate use program for melanoma so patients in need can continue to obtain access to PV-10 while we pursue regulatory approval in the U.S. and abroad."
The primary objective of the Phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions. Additional objectives of the trial are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. The Phase 2 study is an interventional, open-label, multicenter, single group assignment safety/efficacy study. To accurately reflect anticipated clinical use, repeat dosing of lesions not exhibiting complete response is allowed at the investigator's discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10.
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty 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 in the bloodstream, 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 Provectus Pharmaceuticals, Inc. (www.pvct.com)
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, 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 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. Peter R. Culpepper, CFO, 866-594-5999 #30 or Porter, LeVay & Rose, Inc. Marlon Nurse, VP – Investor Relations, 212-564-4700 Bill Gordon, SVP – Media Relations, 212-564-4700
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