PV-10 Data Presented by Moffitt Cancer Center Researchers Examines Induction of Systemic Immune Resp

PV-10 Data Presented by Moffitt Cancer Center Researchers Examines Induction of Systemic Immune Response in Multiple Tumor Types

KNOXVILLE, Tenn.--(BUSINESS WIRE)-- Provectus Pharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced details of a poster presentation on the induction of a systemic immune response with intralesional (IL) PV-10 by researchers from the Moffitt Cancer Center at the American Association for Cancer Research Annual Meeting in Washington, DC.

The poster entitled, "Intralesional Injection with PV-10 Induces a Systemic Anti-tumor Immune Response in Murine Models of Breast Cancer and Melanoma," was presented by Shari Pilon-Thomas, Ph.D., Immunology Program, Moffitt Cancer Center.


Provectus's PV-10, a 10% solution of Rose Bengal, is currently being examined as a novel cancer therapeutic. It is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. In melanoma patients, intralesional (IL) injection of PV-10 has led to regression of injected lesions as well as distant metastases (i.e., bystander lesions).

The Moffitt study examined the immunologic mechanism of PV-10 treatment in murine models of breast cancer and melanoma to determine how IL PV-10 therapy induces the systemic anti-tumor immune response apparent in bystander responses in clinical trial participants. In the current work, IL injection of PV-10 led to regression of injected and untreated contralateral subcutaneous lesions in the MT-901 breast cancer model, with a significant increase in survival in mice treated with IL PV-10 versus those treated with IL saline. In a synchronous flank tumor/lung metastasis model, there was a significant reduction in lung metastases and subcutaneous tumor size in mice treated with IL PV-10 versus those treated with IL saline. Injection of PV-10 into the opposite, non-tumor bearing flank, did not affect the size of subcutaneous lesions nor the number of lung metastases. Splenocytes harvested from PV-10-treated mice exhibited tumor-specific enhancement of interferon-gamma production and cytotoxicity against the treated cell line, along with adoptive transfer of immunity upon implantation in naïve mice. A copy of the poster is available at the following link:

http://www.pvct.com/publications/SPTAACR2013-Final.pdf

Dr. Pilon-Thomas commented, "The findings of this study confirmed not only that PV-10 induces tumor-specific immunity after a single treatment with IL-PV-10 in multiple tumor types, but that the ablative process is critical for this in situ stimulation of the immune system. The data also show that T cells play a critical role in this response. We feel this is a promising direction for additional translational research that will further define the processes that occur systemically following PV-10 treatment."

The work by Dr. Pilon-Thomas and co-workers provided the basis for an ongoing clinical trial at Moffitt Cancer Center, led by Dr. Amod A. Sarnaik, aimed at confirming these immunologic processes in cutaneous melanoma patients. (For further details on this study see: Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study, NCT01760499, http://www.clinicaltrials.gov/ct2/show/NCT01760499?term=pv-10&rank=5).

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 Moffitt Cancer Center

Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt's excellence in research, its contributions to clinical trials, prevention and cancer control. Since 1999, Moffitt has been listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebooktwitter and YouTube.

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 reflect events or circumstances that arise after the date thereof.



Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO
866-594-5999, ext. 30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, SVP - Investor Relations
Bill Gordon, SVP - Media Relations
212-564-4700

KEYWORDS:   United States  North America  District of Columbia  Tennessee

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