Data Highlights Involvement of Immune System in Response to Provectus's PV-10 Therapy and Its Role in the Bystander Effect
Intriguing Results Presented by Dr. Sanjiv Agarwala at Seventh International Symposium on Melanoma and Other Cutaneous Malignancies
Announces Plans to Conduct Research on Mechanism of Action
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Mar 15, 2010 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that Dr. Sanjiv Agarwala, in his presentation at the Seventh International Symposium on Melanoma and Other Cutaneous Malignancies on March 12, 2010, commented on the involvement of the immune system in response to PV-10 therapy and its role in the “bystander effect” in treating metastatic melanoma. Dr. Agarwala's presentation, entitled “Chemoablation in Melanoma: An Update,” was given in the session entitled “Unique Approaches to Melanoma Therapy.”
Dr. Agarwala, Chief, Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus's Phase 2 PV-10 trial site at St. Luke's, noted, “PV-10 is of particular interest to me as an oncologist because it appears to recruit immune cells to the ablation site, leading to the potential of a systemic benefit. Efficacy data from Phase 1 and from the current Phase 2 study demonstrate a close correlation between objective response in treated lesions and response in uninjected lesions. Survival data from both studies further support a conclusion that patients that respond well to PV-10 respond well overall.”
Dr. Agarwala also discussed plans to conduct research into PV-10's immunologic mechanism of action. He said, “I look forward to seeing the results of this research so we can fully understand the potential PV-10 may have in treating not only melanoma, but also other indications in oncology.”
Craig Dees, PhD, CEO of Provectus said, “We are encouraged by Dr. Agarwala's remarks at a time when the medical community has begun to recognize the fundamental importance of immunology in the ongoing fight against cancer. Having completed final follow-up on the first 60 patients enrolled in our Phase 2 study, we look forward to presenting the survival and progression free survival data from at least 40 subjects in June. Further, with our Type B meeting to chart the path to licensure on the FDA schedule, we look forward to reporting on the outcome of that meeting shortly after it occurs.”
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 is a small molecule agent with 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 The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies
The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies will continue a strong history and provide participants with a comprehensive overview of state-of-the-art care of patients with these diseases. Specific topics to be highlighted at this symposium include current risk assessment factors and diagnostic technologies, new prognostic and predictive biomarkers with clinical potential for individualizing treatment, and promising emerging systemic immunotherapies, targeted therapies, and regional therapies for advanced melanoma and other cutaneous malignancies. These topics and the implications for practice will be presented by leading experts in the treatment of these different tumor types. This interactive symposium will also cover practical issues concerning surgical management and adjuvant therapy for these patients. These concepts and practical diagnostic issues will be further reinforced through 2 interactive case-based discussion sessions with the faculty to provide expert insights into their application in practice. Throughout the symposium, participants will also learn about currently accruing high-priority trials and the relevant patient eligibility criteria to enhance enrollment into trials evaluating novel therapeutic regimens in the adjuvant and advanced disease settings for melanoma and other cutaneous malignancies.
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 three of its Phase 2 trials -- PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. 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: March 2010