American Society of Clinical Oncology (ASCO) in San Francisco, California on Friday, January 18, 2019.
Devimistat is Rafael’s lead altered metabolism directed (AMD) drug candidate, a first-in-class anticancer compound designed to disrupt the altered mitochondrial metabolism in cancer cells.
AVENGER 500 will compare the safety and efficacy of FOLFIRINOX (control arm) with devimistat in combination with modified FOLFIRINOX. Patients 18 – 75 years old of both sexes with metastatic (stage IV) pancreatic adenocarcinoma, not previously treated for metastatic disease and with ECOG performance status of 0 – 1 are eligible for enrollment in this study. This is a prospective, open label, multinational randomized trial and will be conducted in 9 different countries including the United States, six European Union countries, Israel and South Korea. Dr. Philip Agop Philip from Karmanos Cancer Institute of Wayne State University is the principal investigator of this trial. More information on the trial is available at www.clinicaltrials.gov (NCT03504423).
Sanjeev Luther, President and Chief Executive Officer of Rafael Pharmaceuticals, commented: “This is a multinational trial in ~100 sites. We are very excited to present the study design of this trial at the 2019 Annual Gastrointestinal Cancers Symposium.”
Philip A. Philip, MD, PhD, FRCP, the Principal Investigator of this study, commented: “Pancreatic cancer is the deadliest cancer worldwide with very limited treatment options. The current data on devimistat in combination with modified FOLFIRINOX in patients battling pancreatic cancer is immensely promising. I am, therefore, delighted to be involved in this important phase 3 trial.”
Timothy S. Pardee, MD, PhD, FACP, Chief Medical Officer of Rafael Pharmaceuticals, commented: “Devimistat targets tumors in a truly unique way and earlier clinical results suggest it leverages the metabolic vulnerability inherent in pancreatic cancer to improve outcomes in this deadly disease. I am very excited at the opportunity to discuss this important trial at such a preeminent meeting.”
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