On October 4, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology development company, reported that it will host a Research and Development (R&D) Day for investors and analysts on Thursday, October 12, 2017 (Press release, Celsion, OCT 4, 2017, View Source [SID1234520777]). The event is scheduled to take place from 4:00 to 6:00 p.m. Eastern Time in New York City, and will be simultaneously streamed as a webcast.

The presentations will focus on the Company’s research and development programs and will feature leading experts in directed chemotherapies, DNA-based immunotherapies and immuno-oncology, including:

ThermoDox – Pivotal Phase III OPTIMA Study for Primary Liver Cancer

Won Young Tak, M.D., Ph.D., Professor Internal Medicine, GI & Hepatology Kyungpook National University Hospital Daegu, Republic of Korea
Stephen N. Wong, M.D., Principle Investigator OPTIMA, Chinese General Hospital, Philippines
Robert M. Eisele, M.D., Deputy Head of Department, Dept. of General, Visceral, Vascular and Pediatric Surgery, Medical Faculty of the University of Saarland, Homburg, Germany

GEN-1 Immunotherapy – A Powerful, Pro-Immune Modulator of Cancer’s Microenvironment

Premal H. Thaker, M.D., Associate Professor in Gynecologic Oncology, Washington University School of Medicine, St. Louis, Missouri
Richard C. Koya, MD, PhD, Associate Professor of Oncology and Immunology, Director of the Vector Development & Production Facility, Associate Director of the Center for Immunotherapy, Roswell Park Cancer Institute, Center for Immunotherapy, Buffalo, NY
A live webcast of the presentations will be available on Celsion’s website at View Source beginning at approximately 4:15 p.m. Eastern Time. To ensure a timely connection, users should register at least 15 minutes prior to the scheduled start. The webcast will be archived for replay following the event for 90 days.

About the OPTIMA Study

The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 70 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus optimized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

About the OVATION Study

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability. GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation.

On October 4, 2017 Bristol-Myers Squibb Company (NYSE:BMY), in collaboration with Blue Faery: The Adrienne Wilson Liver Cancer Association, a leading liver cancer patient advocacy organization, reported the findings from a new survey exploring the experiences of caregivers of people living with early or advanced stage liver cancer in the U.S. According to the caregivers surveyed, 90 percent wish there was more public awareness of the seriousness of a liver cancer diagnosis and 77 percent think liver cancer doesn’t get as much attention as other cancers.1 Bristol-Myers Squibb Company (NYSE:BMY), in collaboration with Blue Faery: The Adrienne Wilson Liver Cancer Association, a leading liver cancer patient advocacy organization, reported the findings from a new survey exploring the experiences of caregivers of people living with early or advanced stage liver cancer in the U.S. According to the caregivers surveyed, 90 percent wish there was more public awareness of the seriousness of a liver cancer diagnosis and 77 percent think liver cancer doesn’t get as much attention as other cancers.1 (Press release, Bristol-Myers Squibb, OCT 4, 2017, View Source [SID1234520776])

This is despite the fact that the incidence of liver cancer in the U.S. has more than tripled since 1980, and hepatocellular carcinoma (HCC) – the most common type of liver cancer – is the fastest-growing cause of cancer death in the U.S.2,3,4

Prior to diagnosis, many caregivers (43%) of patients with advanced stage disease did not think their loved one was at risk for liver cancer, and nearly half (47%) said they were aware of liver cancer but not very knowledgeable.1 In fact, before their loved one was diagnosed, nearly three-quarters of these caregivers (72%) thought that heavy alcohol use was the most common risk factor for liver cancer.1 However, the reality is that chronic infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) is the most common risk factor for liver cancer.4,5

“Before my sister was diagnosed with HCC, I thought the only cause of liver cancer was alcoholism,” said Andrea Wilson, President and Founder, Blue Faery: The Adrienne Wilson Liver Cancer Association. The Liver Cancer Outlook survey found that this is common among liver cancer caregivers, with only one in five (20%) of those surveyed being familiar with risk factors or the signs and symptoms of liver cancer.1 “These survey results reinforce the need to decrease the stigma surrounding the disease and to increase awareness, research efforts and resources available to patients and their caregivers.”

The survey of 90 U.S. caregivers of people living with early stage (n=30) and advanced stage (n=60)1 liver cancer identified a number of insights into the caregiver experience, including:

Limited familiarity with the disease : Few caregivers said they were familiar with risk factors (17%) or the signs and symptoms of the disease (12%), prior to their loved one’s diagnosis.1
Lack of information about treatment options and/or areas of research: More than half of caregivers of people with advanced stage liver cancer surveyed (58%) admit it’s hard to understand what treatment options are available to their loved one. Nearly all (95%) of these caregivers believe more information needs to be available about different types of liver cancer treatment options and/or areas of research, and eight in ten (82%) wish they knew where to go for this information.1
The impact of stigma: Half of the caregivers (56%) agree there is a stigma (i.e., shame) associated with liver cancer and that these negative perceptions about liver cancer make it difficult to find support (60%).1
To address the needs these caregivers identified in the survey and in recognition of Liver Cancer Awareness Month (October), Bristol-Myers Squibb and Blue Faery have launched LiverCancerOutlook.com, a dedicated website offering information about liver cancer and providing links to additional resources for patients and caregivers.

“As a leader in oncology, Bristol-Myers Squibb strives every day to understand and address the unmet needs of patients and their caregivers, including those within the liver cancer community,” said Awny Farajallah, M.D., Vice President, Head of U.S. Medical Oncology, Bristol-Myers Squibb. “The Liver Cancer Outlook survey results underscore the importance of better educating patients and caregivers, and we are proud to collaborate with Blue Faery to help provide much-needed information and hope to those who are living with the daily challenges of the disease.”

In 2017, it is estimated there will be approximately 41,000 new diagnoses of liver and intrahepatic bile duct cancers in the U.S. and an estimated 29,000 people will die from the disease.2 HCC is the most common type of primary liver cancer, cancer that starts in the liver.6 In addition to HBV and HCV infections, gender, race and ethnicity, cirrhosis, obesity, type 2 diabetes, certain genetic syndromes and non-alcoholic steatohepatitis (NASH) are common risk factors.5,7 HCC in adults is often diagnosed in later stages.8,9 A patient’s prognosis depends on factors such as the stage of the cancer (i.e., tumor size, how much of the liver is affected, whether the cancer has spread), how well the liver is working and the patient’s general health.10

The survey uncovered important insights into the attitude and mindset of caregivers. The survey showed that caregiver outlook for their loved one’s future is dependent on the stage of the disease.1 In fact, caregivers of advanced stage liver cancer patients are significantly more likely than those caring for early stage patients to report negative feelings (93% vs. 60%) such as helpless (50% vs. 17%), sad (50% vs. 7%), frustrated (40% vs. 13%), and angry (23% vs. 3%).1

A majority of these caregivers of advanced stage patients acknowledge that a lot of progress is being made in liver cancer research (63%) and that they would feel hopeful about additional treatment options becoming available (58%).1

Research efforts are ongoing, and in the past year additional options have become available for patients with advanced liver cancer. Nearly all caregivers of advanced stage patients (97%) wish they knew about the latest developments in liver cancer treatment or areas of research.1 The most commonly reported treatment option/area of research that these caregivers are interested in learning more about is Immuno-Oncology (93%), followed by targeted therapy (88%), tumor embolization (85%), tumor ablation (83%), liver cancer surgery (83%), chemotherapy (83%), and radiation therapy (78%).1

About Liver Cancer Outlook

The Liver Cancer Outlook survey was conducted online by Bryter on behalf of Bristol-Myers Squibb between July 24 and August 31, 2017 in the U.S., of 90 caregivers of people living with early stage (n=30) and advanced stage (n=60) liver cancer. Only caregivers of patients with active disease were included in the survey. Upon completion of the survey, the data has been tabulated and significance tested at the 95% confidence interval.1 Bryter abides by the rules and guidelines of the Market Research Society. A full methodology is available upon request.

On October 4, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported an update on its Actimab-A drug candidate in acute myeloid leukemia (“AML”) (Press release, Actinium Pharmaceuticals, OCT 4, 2017, View Source [SID1234520775]). The Phase 2 trial is currently enrolling patients with AML age 60 and older who are unfit for standard induction chemotherapy. The Phase 2 clinical trial is now active at 16 clinical trials sites and Actinium has reiterated its previously announced guidance for the trial including a planned interim analysis by the end of 2017 and top line data in the first half of 2018. AML is one of the most common forms of leukemia. Approximately 21,000 patients are diagnosed with AML each year with the median ago of diagnosis being 68 years of age. Patients with AML over the age 60 who are ineligible for standard induction chemotherapy have limited treatment options and have a poor prognosis. Actinium’s Actimab-A targets CD33, a marker expressed in approximately 80-90 percent of patients with AML, via a monoclonal antibody that has been linked to actinium-225 (“Ac-225”), an alpha emitting radioisotope.

Dr. Mark Berger, Actinium’s Chief Medical Officer said, “We at Actinium have great confidence in our alpha-particle technology based drug candidate, Actimab-A, and in its ability to benefit patients. This Phase 2 trial in patients age 60 and older will evaluate the ability of Actimab-A to achieve remissions in these poor prognosis patients. The opening of additional sites will help us achieve our goal of an interim analysis by the end of 2017 and topline data in the first half of 2018. The results from the interim readout at year-end are expected to provide valuable insights into the best ways to use Actimab-A and how to differentiate it from other agents. We expect these insights to inform our development strategy going forward.”

Actinium’s Actimab-A phase 2 trial is currently open for recruitment at the following centers:

Center Location
UCLA Medical Center Los Angeles, California
University of Kentucky Lexington, Kentucky
University of Louisville Louisville, Kentucky
Ochsner Medical Center New Orleans, Louisiana
Weill Medical College of Cornell University New York, New York
Columbia University Medical New York, New York
Memorial Sloan Kettering Cancer Center New York, New York
Duke Cancer Center Durham, North Carolina
University of Pennsylvania Philadelphia, Pennsylvania
St. Francis Cancer Center Greenville, South Carolina
Baylor Scott and White Research Institute Dallas, Texas
Swedish Cancer Institute Seattle, Washington
Fred Hutchinson Cancer Research Center Seattle, Washington
West Virginia University Morgantown, West Virginia
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin
VA Caribbean Healthcare System San Juan, Puerto Rico
Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, “CD33 is a validated target in AML and in our experience a resurgent area of interest amongst the medical community post the recent reapproval of Mylotarg. Importantly, the CD33 space that continues to garner much interest as evidenced by recent drug approvals, strategic transactions and a robust development pipeline represented by several major pharmaceutical and biotechnology companies. We believe that Actimab-A has the potential to be best in the CD33 class given the combination of its potency as a single agent, its relatively simple administration via two injections, and its relative benign safety profile. We look forward to updating by year-end on the significant progress we are making with the Actimab-A trial.”

About Actimab-A

Actimab-A, Actinium’s most advanced alpha-particle therapy product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above that are ineligible for standard induction chemotherapy. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer cells. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 decays it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration.