Provectus Biopharmaceuticals Reports Immune Mechanism of Action Data for PV-10 Presented at Society for Immunotherapy of Cancer Annual Meeting Authored by Researchers at Moffitt Cancer Center

On November 5, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"), reported that researchers from Moffitt Cancer Center in Tampa, Florida, presented a poster titled, "Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity via High Mobility Group Box 1," at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting in National Harbor, Maryland (Press release, Provectus Pharmaceuticals, NOV 5, 2015, http://www.pvct.com/pressrelease.html?article=20151105.2 [SID:1234508057]).

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Authors Hao Liu, Pasquale Patrick Innamarato, Krithika Kodumudi, Amy Weber, John L Robinson, Satoshi Nemoto, Georgina Crago, Timothy McCardle, Erica Royster, Amod A Sarnaik and Shari Pilon-Thomas state that their "results reveal a clinically relevant immunoadjuvant pathway triggered by tumor cell death secondary to ablation with RB." The data presented were from nonclinical models of melanoma in mice and clinical data from the team’s recent clinical mechanism of action study (Clinical Trials ID NCT01760499). To view the poster, visit http://www.pvct.com/publications/SITC-Poster-2015.pdf.

In the reported work, the authors showed that tumor-specific T cells were increased in the blood of both mouse and man after tumor ablation with PV-10. This was initiated by tumor cell necrosis, leading to release of High Mobility Box Group 1 (HMBG1), one of a class Damage-Associated Molecular Pattern molecules (DAMPs) released by dying cancer cells that can lead to activation of dendritic cells. HMBG1 release was observed in vitro and after ablation of melanoma tumors in mice and clinical trial participants. This was also correlated with dendritic cell activation and infiltration into lymph nodes draining ablated tumors.

Eric Wachter, Ph.D., Chief Technology Officer of Provectus, observed, "The data reported by our collaborators at Moffitt further clarify the mechanism by which tumor ablation with PV-10 can initiate a finely tuned immune response against injected tumor cells. This has important potential implications for overall response and durability of response when PV-10 is used as a single agent therapy, while the central role played by T cells in this response is notable for combination of PV-10 with other agents that function on T cells."

Provectus is currently enrolling patients in a phase 3 study of PV-10 as a single agent therapy for patients with locally advanced cutaneous melanoma (Clinical Trials ID NCT02288897) and in a phase 1b study of PV-10 in combination with the immune checkpoint inhibitor pembrolizumab in patients with metastatic melanoma (Clinical Trials ID NCT02557321).

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Dynavax Technologies, NOV 5, 2015, View Source [SID:1234508047])

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Global Analysis Of Metastatic Breast Cancer Landscape Reveals Gaps In Patient Care And Support

On November 5, 2015 Pfizer Inc., working collaboratively with the European School of Oncology (ESO), within the scope of the Advanced Breast Cancer Third International Consensus Conference (ABC3), reported the Global Status of Metastatic Breast Cancer (MBC): A 2005 – 2015 Decade Report, which revealed both areas of improvement and substantial gaps in care, access to resources and support, and treatment outcomes for women with MBC (Press release, Pfizer, NOV 5, 2015, View Source [SID:1234507973]).

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MBC is the most advanced stage of breast cancer for which there is no cure.1 Further, public health experts estimate there will be a 43 percent increase in breast cancer related deaths globally from 2015 to 2030, the majority of which are a result of metastatic disease.2,3 Previous research has shown that women with MBC have distinct needs that are not often addressed and there are fewer patient and community resources available for these women compared with those for women with early-stage disease.4

Over the past decade – due to the collective efforts of the broader breast cancer community – some progress has been made to address the unique needs of women with MBC.5,6 However, there is still a great deal of improvement that needs to be made in this area. The findings from theGlobal Status of MBC: A Decade Report reinforce the urgent need for change in MBC care, patient support, research and the important role increased disease awareness can play.

This report is the most comprehensive analysis to date of the global advanced and metastatic breast cancer landscape over the past decade, and was developed with guidance from a global steering committee (link is external) of multidisciplinary leaders in the MBC community. Results from the preliminary report were presented today at ABC3 in Lisbon, Portugal.7

As a result of these findings, ESO and members of the breast cancer community are calling for policymakers, advocates and the medical community to unite to develop a global charter as a call-to-action toward changing and improving MBC outcomes by the year 2025.

"As members of the global breast cancer community, we need to change the way we comprehend, research and prioritize metastatic breast cancer, a disease that is highly complex clinically and emotionally, yet has received far less attention than other forms of breast cancer," said Fatima Cardoso, MD, director, Breast Cancer Unit at Champalimaud Clinical Center in Lisbon. "The Global Status of MBC: A Decade Report underscores the great challenges that continue to exist in the metastatic breast cancer landscape, and the need for worldwide unity in support of the hundreds of thousands of women living with the disease today."8,9,10,11

The report includes three newly commissioned primary surveys examining current perceptions of the state of breast cancer in 34 countries around the world, including the first survey of global public perceptions of MBC. Secondary analyses were also conducted, and included an analysis of existing breast cancer resources and more than 3,000 previously published articles and abstracts, to determine the global landscape of MBC over the past decade. This analysis examined several key areas of MBC patient care and contains the first comprehensive analysis of the MBC scientific landscape.

"While significant progress has been made in the past few decades in our understanding of breast cancer, there is an unquestionable need for more research surrounding metastatic breast cancer worldwide," said Liz Barrett, global president and general manager, Pfizer Oncology. "Through our work, we hope to leverage our scientific expertise and partnerships with the global breast cancer community to ultimately make metastatic breast cancer a chronic disease where patients can live with their condition and thrive as active contributors to their families and society."

Beyond the results highlighted in the preliminary report, there is ongoing analysis of the policy and socioeconomic aspects of MBC, and additional findings will be presented in 2016.

For more information on the Global Status of MBC: A Decade Report, including methodology, please visit:www.BreastCancerVision.com (link is external).

Primary Survey Highlights

Three new studies evaluating the current state of breast cancer from the perspective of breast cancer care centers, patient support organizations and the general population found:

More than half of 582 surveyed oncologists and other healthcare practitioners in the U.S., Europe, Latin America and Australia, report that they have not been trained on how to effectively deliver difficult information to their patients and have a desire for more training.12

The majority of the 50 interviewed patient support organizations in North America, Europe, Asia Pacific, Latin America, Africa and the Middle East, recognize women with MBC require more support than those with early-stage disease, but report a range of barriers that can impact efforts to meet patient needs, including limited resources, cultural views and logistics.13

There is a global lack of familiarity with metastatic or advanced breast cancer among the general public leading to widespread misperceptions about the disease, according to a survey of more than 14,000 people in 14 countries throughout Europe, Latin America, the Middle East, Africa and the Asia Pacific.14

The survey also found that among the general public, approximately 1 out of 5 people believe that those with metastatic breast cancer should keep their diagnosis a secret and not discuss their disease with anyone other than their physician, potentially contributing to the stigma that is associated with MBC and leading to feelings of isolation by the patient.13,15

These findings reinforce results from a 2014 survey conducted by Pfizer and breast cancer leaders in the United States that found the majority of Americans (60%) know little to nothing about MBC.16

Secondary Analysis Highlights

An analysis of more than 3,000 previously published articles and abstracts identified key limitations to progress for women with MBC over the past decade relating to patient care, the environmental landscape and scientific research, including:

Despite the benefits of supportive and palliative care to the quality of life for patients, implementation of supportive care has been variable across certain countries and significant gaps remain.17,18,19,20,21
Better psychological support for women with MBC is needed to ease the end-of-life care experience, particularly when it comes to anxieties about what they may experience.22,23
There has not been a significant improvement in the quality of life for women with MBC in more than a decade, and there has even been a slight decrease since 2004.24,25,26,27,28,29
The pace of innovation in MBC appears to have slowed in recent years with treatment advances, clinical research, publications and guideline development, particularly when compared with other tumor types, such as melanoma and lung cancer.30,31,32

About Metastatic Breast Cancer

MBC occurs when cancer spreads beyond the breast to other parts of the body, including the bones, lungs, liver and brain.1 An estimated 1.7 million new cases of breast cancer are diagnosed globally each year.7 Globally, five to 10 percent of newly diagnosed breast cancer patients will present with metastatic disease, however, in low- and middle-income countries 50-80 percent are initially diagnosed with advanced disease.8 In developed countries, approximately 20-30 percent of women diagnosed with early breast cancer progress to MBC, and this number may be higher in less developed countries.9,10

Curis Announces Oral Presentation of Phase 1 Data for CUDC-907 at 2015 ASH Annual Meeting

On November 5, 2015 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of cancers, reported that Phase 1 data for CUDC-907, Curis’ proprietary dual histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held from Dec. 5-8, 2015 in Orlando, FL (Press release, Curis, NOV 5, 2015, View Source [SID:1234507991]).

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The Principal Investigator of the study, Dr. Anas Younes, Chief of the Lymphoma Service of the Memorial Sloan Kettering Cancer Center in New York City, will present the data in an oral presentation at the meeting.

Additional information on the presentation can be found below and abstracts can be accessed at www.hematology.org.

Oral Presentation

Date/Session Time: Sunday, Dec. 6, 2015, 12:00 PM – 1:30 PM
Session Name: Lymphoma: Chemotherapy, excluding Pre-Clinical Models: NHL – New Drugs
Presentation Title: Phase 1 Trial Testing Single Agent CUDC-907, a Novel, Oral Dual Inhibitor of Histone Deacetylase (HDAC) and PI3K: Initial Assessment of Patients with Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL), Including Double Expressor (DE) Lymphoma
Presentation Time: 1:00 PM
Location: Orange County Convention Center, W311

Roche to present new clinical data across a variety of blood diseases at American Society of Hematology 2015 Annual Meeting

On November 5, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 5-8 in Orlando (Press release, Hoffmann-La Roche , NOV 5, 2015, View Source [SID:1234508007]). The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Roche is exploring in various blood diseases and lines of treatment.

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"Our data at ASH (Free ASH Whitepaper) this year showcase the evolution of our haematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We’re particularly excited about studies evaluating new combinations with Gazyva/Gazyvaro and venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity."

Data for Gazyva/Gazyvaro include results from combination studies such as the Phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva/Gazyvaro in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Roche will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva/Gazyvaro approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal Phase III GADOLIN study for the investigational use of Gazyva/Gazyvaro in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to MabThera/Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June this year.

Roche will also present findings from multiple studies that suggest a potential role for minimal residual disease (MRD)-negativity in the treatment of certain blood cancers. In collaboration with AbbVie, Roche will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and acute myeloid leukemia (AML). Data will also be shown for investigational medicine ACE910, which was recently granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitors.

The table below contains key abstracts featuring Roche medicines that will be presented. Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH2015.

Separately, the FDA has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen, based on GADOLIN study results. Marketing applications for Gazyva/Gazyvaro have also been submitted to other health authorities, including the European Medicines Agency, for approval consideration in the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. In addition, AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under breakthrough therapy designation, based in part on results of the pivotal Phase II M13-982 study evaluating venetoclax in people with relapsed/refractory CLL harboring the 17p deletion. Roche and AbbVie announced positive top-line results from this study earlier this year.