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Provectus Presents Data on PV-10 Combination Therapy at American Association of Cancer Research Annu

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Provectus Presents Data on PV-10 Combination Therapy at American Association of Cancer Research Annual Meeting

KNOXVILLE, Tenn.–(BUSINESS WIRE)– Provectus Pharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, presented data on PV-10 combination therapy today at the American Association for Cancer Research (AACR) Annual Meeting in Washington, DC.

The presentation, based upon Abstract #4755 entitled, “Combination of PV-10 Immuno-chemoablation and Systemic Anti-CTLA-4 Antibody Therapy in Murine Models of Melanoma,” was authored by Eric Wachter, Savannah Blair, Jamie Singer and Craig Dees, all of Provectus Pharmaceuticals. The poster was presented by Dr. Wachter, Chief Technology Officer.

PV-10 is Provectus Pharmaceuticals‘s novel oncology drug designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Previous preclinical and clinical studies have established that upon intralesional (IL) administration, PV-10 localizes to injected tumor tissues while rapidly clearing from healthy tissue. Intralesional injection with PV-10 focuses the ablative impact on injected tumors and minimizes the potential for systemic side effects, making it an attractive candidate for both monotherapy and for combination therapy with other agents.

In Phase 2 testing PV-10 elicited an objective response rate of 51% in melanoma patients (CR: 25%; PR: 26%) after 1-4 treatment cycles, with a third of patients experiencing an objective response in their monitored untreated tumors (CR: 26%; PR: 7% in 42 patients with monitored untreated lesions). This apparent immune-mediated bystander response was highly correlated with successful ablation of injected tumors. Recent mechanism studies in B16 murine melanoma tumor lines have confirmed that PV-10 ablation induces T-cell mediated tumor-specific immunity, resulting in marked suppression of untreated metastases and tumor-specific IFN-ˠ production.

The data presented today at AACR utilized systemic immune stimulation by the anti-CTLA-4 antibody 9H10 to explore the potential benefit of combination therapy with PV-10 immuno-chemoablation in murine melanoma. Because advanced melanoma patients, particularly those with stage IV disease, have substantial tumor burden in areas that are often non-accessible to injection with PV-10, combination of PV-10 with systemic therapy may afford advantage in control of uninjected disease while the immunologic effects of PV-10 reach full potential. By combining PV-10 with the anti-CTLA-4 antibody 9H10 in very aggressive murine models of metastatic disease, researchers at Provectus aimed to ensure that any systemic treatment was potentially safe in combination with PV-10, and that efficacy signals from the combination therapy could be differentiated from those of PV-10 alone.

In order to discriminate the systemic effect of PV-10 alone from that in

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Immunology Data on PV-10 to Be Presented at the American Association for Cancer Research Annual Meet

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Immunology Data on PV-10 to Be Presented at the American Association for Cancer Research Annual Meeting

— Moffitt Cancer Center Poster Presentation on April 8, 2013 —

KNOXVILLE, Tenn.–(BUSINESS WIRE)– Provectus Pharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announces that mechanism data on the induction of tumor specific immunity after intralesional PV-10 treatment will be presented by researchers from Moffitt Cancer Center and the University of South Florida in a poster presentation at the American Association for Cancer Research Annual Meeting in Washington, DC.

The poster, based upon abstract #1248 entitled “Intralesional Injection with PV-10 Induces a Systemic Anti-tumor Immune Response in Murine Models of Breast Cancer and Melanoma,” authored by Shari A. Pilon-Thomas, Amy Weber, Krithika Kodumudi, Lisa Kuhn, Paul Toomey, Amod Sarnaik, will be presented on April 8, 2013, from 1:00 p.m. – 5:00 p.m. in Hall A-C, Poster Section 5, Poster #28.

Craig Dees, Ph.D., CEO of Provectus Pharmaceuticals said, “The researchers at Moffitt are providing valuable insights into how PV-10 harnesses the immune system in specific response to the injected tumor. Although the study being presented was done in murine models of melanoma and breast cancer, the currently open clinical trial at Moffitt is designed to investigate this mechanism in melanoma patients. We are pleased to enhance our understanding of intralesional PV-10 and its potential to produce a systemic benefit in cancer patients.”

PV-10 is Provectus Pharmaceuticals‘ novel oncology drug designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects.

About the American Association for Cancer Research

The AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research. Its reputation for scientific breadth and excellence attract the premier researchers in the field. The programs and services of the AACR foster the exchange of knowledge and new ideas among scientists dedicated to cancer research, provide training opportunities for the next generation of cancer researchers, and increase public understanding of cancer.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy …read more
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Data on Provectus's PV-10 to Be Presented at the HemOnc Today – Melanoma and Cutaneous Malignancies

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Data on Provectus’s PV-10 to Be Presented at the HemOnc Today – Melanoma and Cutaneous Malignancies Conference on March 22, 2013

KNOXVILLE, Tenn.–(BUSINESS WIRE)– Provectus Pharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announces that data on PV-10 for metastatic melanoma will be included in a presentation at the HemOnc Today – Melanoma and Cutaneous Malignancies Conference on Friday, March 22, 2013 in New York.

Dr. Robert H.I. Andtbacka, Assistant Professor of Surgical Oncology, Huntsman Cancer Institute at the University of Utah in Salt Lake City, is scheduled to present during conference session on Local-Regional Therapy. His presentation, “Current Status of Injectable Therapy” begins at 1:55 p.m., EDT. This session will be moderated by Sanjiv S. Agarwala, MD, Principal Investigator for the Phase 2 trial of PV-10, and Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA.

Dr. Craig Dees, PhD, CEO of Provectus said, “We are pleased to be participating in this important conference. We expect Dr. Andtbacka’s presentation will support PV-10’s utility in the treatment of metastatic melanoma.”

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and 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 …read more
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