C3,” a Combination of 3 Generic Drugs Designed to Halt Advanced Adenocarcinoma Pancreatic Cancer Moves from the Lab to Human Trials
MIAMI, FLORIDA, UNITED STATES, July 4, 2023/EINPresswire.com/ — The Cure Alliance, 501(c)(3) non-profit, announced today State University of New York, Downstate Health Science Center has given Institutional Review Board (IRB) approval to proceed with an FDA-cleared phase II clinical trial designed to halt advanced stage adenocarcinoma pancreatic cancer with “C3,” a novel combination of three widely-available low-cost generic drugs.
With standard treatment, this deadly cancer has one of the lowest survival rates of any cancer at 12%.
The FDA exempted “C3” from an IND review (investigation of a new drug) expediting clinical trials. This year, The Cure Alliance offered to fully fund a new two-year trial, and in April, SUNY Downstate Health Science Center accepted the sponsorship.
Under FDA regulations, a formal IRB must still review all details to ensure the clinical trial is in compliance with applicable regulations, ethical standards and institutional policies and, most importantly, to safeguard the welfare and rights of human research participants. IRB approval is the final stage before patients can be enrolled.
“The Cure Alliance is grateful for the meticulous efforts of the SUNY Downstate Health Science Center IRB committee in granting this approval. We are looking forward to the launch of this most important trial with Dr. Mohan Preet as principal investigator,” said Shelley Ross, President of The Cure Alliance who led the fundraising efforts for the “C3” project with fellow board member and founder, Professor Camillo Ricordi, M.D., Director of Cell Transplant Center and Director Emeritus, Diabetes Research Institute, University of Miami, Florida.
“C3” is the brainchild of Dr. F. Charles Brunicardi who has been working on a cure for pancreatic cancer for 28 years. He and his research team were first to develop the idea to screen the FDA library of 2500 approved drugs using “super-promoters-of-cancer targets” to determine if any combination of generic drugs would halt adenocarcinoma pancreatic cancer. “C3” is a result of that search.
Dr. Brunicardi currently serves as Senior Vice President and Dean, College of Medicine at SUNY Downstate Health Science Center. He has embraced the courage of the clinical investigators, independent of him, to forge ahead with the trial at SUNY Downstate Health Science Center.
“Mining the FDA list of generic drugs to treat cancer could be a game-changer, saving years of research and billions of dollars. Along with my colleagues, I am grateful to The Cure Alliance donors who have made this trial possible.”
Dr. Brunicardi brings more than three decades of experience in academic medicine and patient care, serving on the faculty at three medical schools and as Chair of two departments of Surgery and Vice-Chair of another. Dr. Brunicardi has been perennially listed among the nation’s “Top Doctors” by Castle Connolly, Ltd. He has published 318 papers and has served as the Editor-in-Chief of Schwartz’s Principles of Surgery since 2000. The most recent, the 11th edition of Schwartz’s Principles of Surgery, is considered the world’s leading surgical textbook
Enrollment details for the “C3 “trial will soon be posted on www.clinicaltrials.gov.
The Cure Alliance is a boutique 501(c)(3) non-profit group of top scientists, researchers, medical doctors and innovators, plus those who support our efforts to end human suffering by developing cures for chronic, debilitating and fatal diseases. Our #1 mission is to help move potential cures from the laboratory to the patient’s bedside.