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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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Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C

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Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C


— Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients —

FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences (NAS: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States. Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN, which has to be injected and is associated with significant side effects, leaving some patients unable to complete therapy. If approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and depending on the genotype, would either eliminate or reduce the duration of peg-IFN injections.

“Current therapies are not suitable for large numbers of patients with HCV infection, and are challenging to take and tolerate,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Sofosbuvir’s antiviral potency, safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease.”

The sofosbuvir NDA is supported primarily by data from four phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV.

Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency (EMA) …read more

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Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir

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Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients


— Enrollment in ION-1 Study Continues Following Planned DSMB Review —

FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (NAS: GILD) today provided an update on ION-1, a Phase 3 clinical trial evaluating a once-daily fixed-dose combination of the nucleotide sofosbuvir and the NS5A inhibitor ledipasvir with and without ribavirin (RBV) for 12 or 24 weeks among treatment-naïve genotype 1 patients with hepatitis C virus (HCV) infection (n=800). A planned review by the study’s Data and Safety Monitoring Board (DSMB) of safety data from 200 patients in all four arms and of SVR4 rates (sustained virologic response four weeks after completion of therapy) from 100 patients in the two 12-week duration arms concluded that the trial should continue without modification. This recommendation is based upon the observed SVR4 rates exceeding the predefined threshold of 60 percent and the absence of significant safety issues. Enrollment of the remaining 600 patients in ION-1 is now underway.

Sofosbuvir/ledipasvir is also being evaluated in a second Phase 3 study, ION-2, initiated in January 2013, which is now fully enrolled. ION-2 is evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and without RBV for 24 weeks, among 400 treatment-experienced genotype 1 HCV patients. Participants in this study failed to respond to past therapy containing pegylated interferon (peg-IFN) or peg-IFN plus a protease inhibitor.

Sofosbuvir, ledipasvir and the sofosbuvir/ledipasvir fixed-dose combination are investigational products and their safety and efficacy have not yet been established.


About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.


Forward-Looking Statement

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New TYSABRI Data Reaffirm Substantial Efficacy in Treatment of People with MS and Demonstrate Stabil

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New TYSABRI Data Reaffirm Substantial Efficacy in Treatment of People with MS and Demonstrate Stability of Anti-JCV Antibody Status

– Continued Research into Risk Stratification and PML Early Detection Provides Additional Insights for Physicians –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) and Elan Corporation, plc (NYS: ELN) announced results from several studies of TYSABRI® (natalizumab) that demonstrate its efficacy compared to other multiple sclerosis (MS) treatments, provide additional data supporting anti-JC virus (JCV) antibody status stability, and suggest better outcomes when progressive multifocal leukoencephalopathy (PML) is detected early. These data will be presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego.

“These new data reinforce our belief in the substantial efficacy TYSABRI has demonstrated at both the early and advanced stages of relapsing forms of MS,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and chief medical officer, Biogen Idec. “We are also encouraged by the consistency in anti-JCV antibody status demonstrated over 18 months, as well as results from our pursuit of additional paths to help mitigate the impact of PML. These combined efforts may allow a more individualized approach when selecting TYSABRI treatment, while helping physicians better understand a patient’s benefit-risk profile.”

Substantial TYSABRI Efficacy Demonstrated Against First-Line Therapies

In an independent statistical analysis led by Timothy Spelman and Helmut Butzkueven, M.D. at the University of Melbourne, with contribution by Fabio Pellegrini and Annie Zhang, TYSABRI demonstrated a significantly lower rate of first relapse compared to interferon beta (IFN) and glatiramer acetate (GA). This propensity-matched analysis was conducted using data from two MS patient registries: TYSABRI Observational Program (TOP) and MSCOMET. The results indicate that relapses were not only more likely to occur in patients taking IFN and GA, but that they occurred more quickly, when compared to patients taking TYSABRI (hazard ratio 2.73, 95 percent confidence interval 2.10-3.55, p<0.001).

  • Comparison of Patients Treated with Natalizumab and Interferon-Beta/Glatiramer Using Propensity-Matched Multiple Sclerosis Registry Data (P01.211) will be available for viewing on Monday, March 18, 2013 from 2:00 to 6:30 p.m. PDT

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