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Atlantic Health System Leads Phase 1 Study on CPI-613® (Devimistat), First-in-Class Treatment for Pancreatic Cancer to be Presented at American Society of Clinical Oncology (ASCO) 2020

June 1, 2020

ASCO meeting is world’s premier venue for presenting clinical research on cancer

May 28, 2020 - Morristown, NJ – Atlantic Health System Cancer Care’s Angela Alistar, MD, medical director of GI medical oncology at Morristown Medical Center and medical director of the Phase 1 Breakthrough Treatment Center, is lead author of a phase 1 study of CPI-613® (devimistat), a unique first-in-class treatment for locally advanced or metastatic pancreatic cancer, in combination with two chemotherapy drugs. Dr. Alistar will present the study results in a poster session at 8:00 a.m. ET on Friday, May 29 during the 2020 American Society of Clinical Oncology (ASCO) Virtual Program. The ASCO meeting, held virtually this year due to COVID-19, is the world’s premier scientific gathering of cancer specialists and clinical researchers.

Dr. Alistar is the principal investigator (PI) on this phase 1 study, which she designed, at Atlantic Health System’s Morristown Medical Center and Overlook Medical Center, the only sites for the study. Dr. Alistar has pioneered the use of CPI-613 (devimistat), which uniquely targets enzymes involved in cancer cell metabolism, against pancreatic cancer. Her studies of this drug have been presented at major oncology meetings and published in leading medical journals, including The Lancet Oncology. The current study was funded by the drug’s manufacturer, New Jersey-based Rafael Pharmaceuticals and by Atlantic Health System.

“Devimistat holds great promise for changing the course of this chemoresistant cancer,” said Dr. Alistar. “Although this is an early-stage study, the results are very encouraging and shed a light on the best treatment strategies. I am thrilled to see that the study results met my expectations of good tolerance of devimistat in combination with the two chemotherapy drugs.”

During the ASCO meeting, Dr. Alistar will report on a single-arm, open-label study of devimistat in combination with chemotherapeutic agents gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer.  The purpose of the study was to determine the maximum tolerated dose, safety and preliminary efficacy of devimistat in combination with chemotherapy. Overall, the treatment was well-tolerated and demonstrated positive results that show devimistat can be safely administered with gemcitabine and nab-paclitaxel at doses up to 1,500 mg/m2. The study’s efficacy data suggest devimistat has synergy with chemotherapy. Dr. Alistar is also helping lead a Phase 3 trial of chemotherapy alone versus devimistat plus chemotherapy for metastatic pancreatic cancer.

“Dr. Alistar has truly pioneered this new type of cancer treatment, as it pertains to pancreatic cancer,” said Eric D. Whitman, MD, medical director, Atlantic Health System Cancer Care. “She and her colleagues are enabling us to lead some of the most innovative oncology trials in the world, including many phase 1 trials of breakthrough therapies such as this one.”

Hear more from Dr. Alistar on the devimistat study in this video.

About Atlantic Health System Cancer Care

Atlantic Health System Cancer Care offers an unparalleled network of cancer specialists and resources for more than 70,500 patients annually through its flagship Carol G. Simon Cancer Center at Morristown and Overlook medical centers, as well as its comprehensive oncology programs at Chilton, Hackettstown and Newton medical centers. With more than 250 cancer specialists and medical professionals, all five hospitals and Atlantic Medical Group have been recognized nationally for their role in advancing the fight against cancer.

Atlantic Health System Cancer Care is the lead affiliate of Atlantic Health Cancer Consortium (AHCC) - the only New Jersey-based National Cancer Institute (NCI) Community Oncology Research Program (NCORP).  The NCORP develops and implements NCI cancer prevention, screening, care delivery, and treatment studies with leading healthcare systems across the state.  Atlantic Health System Cancer Care is affiliated with the Translational Genomics Research Institute (TGen) of Phoenix, Arizona, and together they have created the Breakthrough Oncology Accelerator, a pioneering research and clinical collaboration designed to improve patient access to the most innovative and sophisticated therapies for cancer.

About Atlantic Health System

Atlantic Health System has a long-standing tradition of providing exceptional patient outcomes and experiences. Home to seven award-winning hospitals including Morristown Medical Center, the number one hospital in NJ according to U.S. News & World Report, Castle Connolly and Newsweek’s World’s Best Hospitals, the system has been ranked first in New Jersey in consumer preference by Monigle and first among health systems in New Jersey as a “best workplace” by both Modern Healthcare and Fortune Magazine.

Many of the system’s programs have received national accolades and designations, including Morristown Medical Center’s Cardiology and Heart Surgery program ranked among the top 30 in the nation by U.S. News and World Report; Morristown Medical Center’s Orthopedics program ranked among the top 35 in the nation by U.S. News and World Report and Atlantic Health System’s Cancer Care program, New Jersey’s first and only National Cancer Institute National Community Oncology Research Program. Additionally, Atlantic Health System Neuroscience at Overlook Medical Center, working with Atlantic Mobile Health, was the first in the nation to deploy and use portable Telestroke technology in ambulances for routine pre-hospital assessment of stroke patients.

Powered by a passionate workforce of 17,000 team members and 4,800 affiliated physicians dedicated to building healthier communities, Atlantic Health System serves more than half of the state of New Jersey, including 11 counties and 4.9 million people. The system provides care for the full continuum of health needs across a wide array of settings, including Atlantic Medical Group, one of the largest multi-specialty practices in New Jersey with more than 1,000 physicians and providers, 12 urgent care centers, Atlantic Rehabilitation Institute, Atlantic Visiting Nurse and Atlantic Anywhere’s Virtual Visits. Facilitating connections between these services on both land and air is the transportation fleet of Atlantic Mobile Health.

With a clear sense of purpose and an unparalleled culture, Atlantic Health System attracts top leaders in the field of health care, from CEO Brian Gragnolati, who was Chairman of the American Hospital Association in 2019, to the numerous team members who serve as leaders across national clinical associations and research entities.

About CPI-613® (devimistat)

CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael Pharmaceuticals, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represents a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.