Palisade Bio Launches Clinical Steering Committee to Provide Clinical Oversight and Guide Preparation for Late-Stage Clinical Trials of LB1148 in Accelerating Postoperative Return of Bowel Function and Reduction of Post-Surgical Adhesions
CARLSBAD, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the launch of its Clinical Steering Committee (CSC) designed to provide strategic guidance over late-stage clinical program development for its lead investigational drug, LB1148. The CSC will be chaired by retired board-certified-surgeon, Dr. David Berry, who previously served as Chairman of the Board of the predecessor company, Leading BioSciences.
Additional CSC members include:
“With a number of important clinical milestones expected in 2021, our Clinical Steering Committee will be integral to successful design and execution of our planned pivotal Phase 3 programs in 2022,” said Tom Hallam, Ph.D., CEO of Palisade Bio. “We're driven by the potential for LB1148 to be a difference-maker in prevention of a number of post-surgical GI complications and look forward to working with Dr. Berry and the rest of the CSC to advance these programs expeditiously.”
Palisade Bio is currently in a Phase 2 clinical trial evaluating lead drug candidate LB1148 for accelerating return of bowel function associated with gastrointestinal (GI) surgery. The PROFILE study is a randomized, double-blind, multicenter, Phase 2 trial expected to enroll 120-200 patients undergoing elective bowel resection at 11 sites across the U.S. Patients received a single oral dose of LB1148 prior to surgery. The primary endpoint is time to return of bowel function. The presence of adhesions will be assessed in patients scheduled for a second surgery withing seven months of the initial GI surgery.
A sister Phase 2 study that is virtually identical in design to PROFILE, was recently completed with co-development partner Newsoara (Shanghai, China). It included more than 120 patients, has the same primary and secondary endpoints as PROFILE, and preliminary top-line data are expected to be announced by the end of Q2 2021.
Dr. Berry remarked, “With the imminent data from Phase 2 clinical trials of LB1148 we're entering a critical juncture for design of late-stage pivotal trials that we hope will generate the data supportive of FDA approval. I look forward to continuing to work with the exceptional team at Palisade Bio to advance the global LB1148 clinical program t potentially bring this much needed oral therapy to market as a safe and effective therapeutic option to restore bowel function after surgeries and reduce post-surgical abdominal adhesions.”
Before joining the CSC at Palisade Bio, Dr. Berry brought deep medical, business and board leadership to Leading BioSciences. He is a retired urologic surgeon with 36 years of experience in endoscopic and open surgical procedures. He has served as a clinical associate professor at the University of Nevada Medical School and diplomate of the American Board of Urology. Committed to cutting-edge medical research, his roles have ranged from advisory boards to principal investigator for clinical trials. In addition to his clinical and scientific achievements, Dr. Berry is also an accomplished entrepreneur and business executive, having founded multiple profitable healthcare companies spanning surgical and oncology radiation centers, medical management, and health insurance. Dr. Berry earned his bachelor’s degree in biology from The College of Wooster (Wooster, Ohio) and his medical degree from Tulane University. He completed his general surgery residency training at the University of California Davis, and his urologic residency training at Tulane Affiliated Hospitals in New Orleans, Louisiana. During his training at Tulane, Dr. Berry also completed a cancer research fellowship and served as fellow for the National Prostate Cancer Project.
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Source: Palisade Bio