Provectus Completes Treatment of All Patients in Phase 2 Trial of PV-10 for Metastatic Melanoma
All scheduled retreatments completed for all patients in September 2009
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Sep 21, 2009 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical 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, “Completing this portion of the Phase 2 trial of PV-10 for metastatic melanoma is an important milestone in our efforts to develop a new treatment alternative for this horrendous disease. With compelling interim data presented at the American Society of Clinical Oncology (ASCO) a few months ago, completing this phase of the study furthers our PV-10 development efforts. As we prepare to seek additional guidance from the FDA regarding the actions we need to take to obtain approval for this treatment, we are concurrently taking steps to either seek licensure agreements and/or partnerships that would facilitate final development of this novel oncology drug. We believe PV-10 is a promising therapy that could be of great value to our company and our potential partners.”
“We look forward to providing interim results to our shareholders and the medical community as we complete the analysis of the 80 patients in this trial,” he concluded.
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 was allowed at the investigator's discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10. The estimated primary completion date for this trial is May 2010, with an estimated study completion date of July 2010.
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic 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 specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in two of its Phase 2 trials -- PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis. It is currently conducting a Phase 2 clinical trial for PH-10 as a topical treatment for psoriasis. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. 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.
Contact: Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, 866-594-5999 #30
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP – Investor Relations
Bill Gordon, SVP – Media Relations
Posted: September 2009