National Melanoma Awareness Month kicks off with Melanoma Monday, May 4th

Knoxville, TN -- (ReleaseWire) -- 05/04/2015 -- The American Academy of Dermatology has designated the month of May as National Melanoma Skin Cancer Prevention Month to raise awareness about skin cancer, increasing the chances of early detection so treatments can be given early. The first Monday in the month is called Melanoma Monday. The goal is to raise awareness about melanoma. Melanoma is an aggressive form of skin cancer in which cells within moles on the skin becoming malignant (cancerous) and can spread rapidly to other areas of the body if left untreated.

Melanoma is the deadliest form of skin cancer. According to the American Cancer Society, although melanoma accounts for less than 5 percent of skin cancer cases, it is responsible for about 75 percent of all skin cancer deaths. When melanoma is detected early and treated before it spreads to the lymph nodes, the five-year survival rate is approximately 98 percent. However, when the disease spreads, the five-year survival rate drops considerably — to 62 percent in patients whose melanoma has spread to the lymph nodes and only 16 percent in patients whose melanoma has spread to other organs.

Within the last few years, significant progress has been made in treating advanced melanoma when the disease has spread beyond the skin. Now, new treatments such as immunotherapeutics, molecularly targeted therapies, and intralesional therapy are offering a glimmer of hope in stopping the progression of advanced melanoma and prolonging life for patients fighting this deadly disease.

Sanjiv S. Agarwala, MD, an internationally recognized investigator in the field of melanoma and immunotherapy and chief of medical oncology and hematology for St. Luke's University Hospital & Health Network (based in Bethlehem, PA) is available for media interviews and can discuss the following:

- What is the importance of early melanoma detection when it comes to treatment?
- Would you briefly compare melanoma versus squamous cell carcinoma versus basal cell carcinoma? What sets melanoma apart?
- How are late-stage melanoma lesions treated today? Is there room for improvement?
- What roles does the immune system play against melanoma?
- What are intralesional therapies and how do they work?
- Why may late-stage melanoma patients need to try multiple approaches?
- What are some newer therapies that are promising and pushing ahead in clinical trials?
- Where can patients get information on new trials?

About Dr. Sanjiv Agarwala
Dr. Sanjiv Agarwala is chief of medical oncology and hematology at St. Luke's Cancer Center in Bethlehem, PA, and professor of medicine at Temple University School of Medicine in Philadelphia. He is nationally and internationally recognized as an expert in the research and treatment of melanoma and cutaneous malignancies. He graduated from the University of Bombay and did residencies and fellowships at the University of Bombay in India, Dunedin University in New Zealand and University of Pittsburgh in Pittsburgh, PA. Dr. Agarwala has special interest and expertise in immunotherapy for cancer. He has been principal investigator for several clinical trials involving immunotherapy and targeted therapy for melanoma and other malignancies. He has written more than 100 publications and book chapters on melanoma and other research areas. He is board-certified in oncology, hematology and internal medicine, and is an active member of several professional and scientific societies, including the American Association for Cancer Research, the American Society of Clinical Oncology, the European Society of Medical Oncology and the Society for Melanoma Research.

Mentioned in interview:

About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby 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. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for 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 http://www.pvct.com or contact Porter, LeVay & Rose, Inc., 212.564.4700

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Knoxville, TN -- (SBWIRE) -- 02/13/2015 -- Despite advances in melanoma treatment, many patients with unresectable, multiple or advanced locally/regionally metastatic stage IIIB/C or stage IV M1a melanoma will need several lines of therapy according to a recent paper in Current Opinion in Oncology.

Sanjiv S. Agarwala, MD, wrote "Intralesional therapy for advanced melanoma: promise and limitation," and enumerated three key points:

-Risk for recurrence, progression and metastasis is high among patients with unresectable, multiple or advanced locally/regionally metastatic stage IIIB/C or stage IV M1a melanoma.

-Most recent clinical trials of intralesional therapies show promise for their response rates, low toxicity and likely systemic immunological effects.

-Ongoing and planned clinical trials will test T-VEC in combination with systemic immunological therapies and PV-10 as monotherapy versus chemotherapy in patients who have failed or are ineligible for systemic immunological therapy.

Dr. Agarwala is Professor of Medicine, Chief, Oncology & Hematology, St Luke's Cancer Center and Temple University, and his article has been published in the March issue of Current Opinion in Oncology, now available online. Dr. Agarwala notes that for decades, the standard of care has been dacarbazine chemotherapy and high-dose interleukin (IL)-2 as they are the only US Food and Drug Administration (FDA)-approved agents for advanced disease, however, both drugs are limited in their efficacy and application.

With the advent of agents targeting the MAP-kinase pathway and the discovery of more effective immunologic agents, several new drugs have been approved in the past two years.

Among the new approaches, Dr. Agarwala discusses intralesional therapies with agents that may not only shrink the tumor directly but also stimulate a systemic immune response by modifying the tumor's antigenic milieu through intratumoral injection of therapeutic agents. These are promising treatments because melanoma has a unique and close relationship with the immune system, with tumor infiltration by lymphocytes often indicating the attempt of the immune system to eliminate the tumor.

The paper delves into the research history of the first intralesional treatment Bacille Calmette-Guerin (BCG), as well as the newer treatments Allovectin-7 (velimogene aliplasmid), plasmid IL-12, talimogene laherparepvec (T-VEC) and Provectus Biopharmaceutical's PV-10.

Dr. Agarwala's findings stated,
After promising phase 2 results with Allovectin-7 (velimogene aliplasmid), overall survival in a phase 3 study was shorter for Allovectin-7 than for dacarbazine/temozolomide (median 18.8 versus 24.1 months). In a phase 2 trial of intratumoral electroporation of plasmid interleukin-12 among 28 patients with advanced melanoma, the primary endpoint of best overall response rate within 24 weeks of first treatment was 32.2% for objective response and 10.7% for complete response. In the phase 3 OPTiM trial of talimogene laherparepvec, the intralesional agent that is furthest along in clinical testing, the primary endpoint of durable response rate was 16% for talimogene laherparepvec and 2% for granulocyte macrophage colony-stimulating factor. In the PV-10 phase 2 trial among 80 patients with stage III–IV melanoma, the overall response rate was 51%, with a 26% complete response rate.

Provectus Biopharmaceuticals, the developer of PV-10, recently held a meeting with the FDA to refine its proposed phase 3 study of PV-10. Topics formally reviewed included subject eligibility requirements, primary and secondary study end points, and study lesion definitions and conventions for defining disease progression. Provectus is incorporating the FDA's comments from this meeting into its protocol and intends to issue the final version before the end of February. No further review is necessary from the FDA to begin enrolling the PV-10 phase 3 melanoma study after the changes to the protocol discussed already with the FDA are made this month. The Company has 8 sites, 4 in the US and 4 in Australia, that will receive this final version and begin the study immediately upon receipt, and Provectus is in the process of qualifying many more to join in the study.

Dr. Agawala states that interest in emerging intralesional therapies is justified by their strong ablative effects, lack of toxicity and their stimulation of local and systemic immunological responses. He maintains this despite the development of systemic immunotherapies, which have brought significant improvements in outcomes for patients with metastatic melanoma.

He concludes, "What remains unclear at this early stage of experience with the agents in current development is how clinically significant the evoked systemic effects will be, and further, what combinations of intralesional therapy and systemic immune therapy will reap the greatest benefits for patients. Future clinical trials, it is hoped, will help answer these questions and provide yet another potentially effective approach to treat our patients with melanoma,"

The entire article may be found at: http://journals.lww.com/co-oncology/Fulltext/2015/03000/Intralesional_therapy_for_advanced_melanoma__.12.aspx

About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby 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. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for 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, http://www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at http://www.pvct.com or contact Porter, LeVay & Rose, Inc.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Knoxville, TN -- (SBWIRE) -- 12/04/2014 -- Rose Bengal has been around for decades starting as a way to dye wool. Originally used in medicine as a stain for ophthalmologists, it has a solid safety record going back to the 1930s. Recently, oncologists have examined its efficacy against cancer, specifically melanoma.

Clinical trials have shown that a preparation of rose bengal produced by Provectus Biopharmaceuticals, known among researchers as PV-10, has induced regression of both injected lesions and uninjected bystander lesions in patients with melanoma, and tumor ablation with PV-10 has been shown to increase certain T-cell populations in patients' peripheral blood. Provectus recently submitted a protocol for a phase 3 study to the FDA.

However, research suggests that there are additional approaches to using PV-10 as an anti-cancer drug. In a study recently reported at the 29th annual meeting of the Society for Immunotherapy of Cancer, a team from Moffitt Cancer Center measured whether IL PV-10 and co-inhibitory blockade could improve anti-tumor immunity and regression of melanoma in mice.

The presentation by Dr Shari Pilon-Thomas of the Moffitt Cancer Center, concludes that the new data "support combination therapy with IL PV-10 and co-inhibitory blockade." The title was "Efficacy of Intralesional Injection with PV-10 in Combination with Co-Inhibitory Blockade in a Murine Model of Melanoma," is available at http://www.pvct.com/publications/SITCposter2014.pdf.

The testing assessed response of injected and uninjected B16 melanoma tumors in mice receiving PV-10 alone or in combination with one of three agents designed for co-inhibitory blockade. The tested agents targeted either CLTA-4, PD-1 or PD-L1, the three most common clinical targets for co-inhibitory blockade. In each case, combination of PV-10 with co-inhibitory blockade led to improved tumor response and enhanced anti-tumor immunity of T-cells. Further testing with the anti-PD-L1 agent showed that these improvements could apply to both injected and uninjected tumors.

Eric Wachter, PhD and Chief Technology Officer of Provectus, said, "This important work further validates use of an intralesional therapy with a systemic immunotherapy, and solidifies our plans for a promising second path for development of PV-10. In addition to use as a single-agent therapy for cutaneous melanoma (the focus of our phase 3 study), these findings support commencement of clinical testing of PV-10 in combination anti-CLTA-4, anti-PD-1 or anti-PD-L1 agents. We are assessing strategies to allow this work to commence in a timely and cost-effective manner so that we can begin translating these model test results into human clinical data."

Combination therapies are grabbing not just headlines but also the attention of big pharma as well. Pfizer and Merck have gone so far as to begin a joint study of Pfizer's crizotinib (XALKORI®) with Merck's investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study. With PV-10 entering a phase 3 trial as an intralesional treatment for melanoma, and with results Dr. Pilon-Thomas and her team announced at SITC, the future for rose bengal as an anti-cancer drug, either on its own or in combination with another drug, looks rosy indeed.

About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc., specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby 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. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for psoriasis and atopic dermatitis. Provectus has 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, http://www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at http://www.pvct.com

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm