Palisade Bio Launches Clinical Steering Committee to Provide Clinical Oversight and Guide Preparation for Late-Stage Clinical...
June 15 2021 - 7:15AM
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:
- Mark A. Talamini, MD, Vice President of Surgery & Program
Development, Northwell Health
- Jerrold H. Levy, MD, Professor of Anesthesiology and Critical
Care Professor of Surgery (Cardiothoracic) Duke University
Hospital
- Steven D. Wexner, MD, PhD, Director of the Digestive Disease
Institute and Chairman of Colorectal Surgery, Cleveland Clinic
Florida
- Ronald Hurst, MD, Division of Surgical Oncology at The Angeles
Clinic and Research Institute
- Paul A. Checchia, MD, Professor of Pediatrics at Texas
Children's Hospital
“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 to 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.
About LB1148LB1148 is an oral formulation of a
broad-spectrum serine protease inhibitor designed to neutralize the
activity of potent digestive proteases released from the gut during
surgery. Evidence suggests that the release of digestive proteases
contributes to the temporary loss of normal gastrointestinal
function and formation of postoperative adhesions. By inhibiting
the activity of these digestive proteases, LB1148 has the potential
to prevent damage to GI tissues, accelerate the time to return of
normal GI function, and shorten the duration of costly post-surgery
hospital stays.
About Palisade Bio, Inc.Palisade Bio is a
late-stage biopharma company advancing therapies that help patients
with acute and chronic gastrointestinal complications stemming from
post-operative digestive enzyme damage. Palisade Bio’s innovative
lead asset, LB1148, is a Phase 3-ready protease inhibitor with the
potential to both reduce abdominal adhesions and help restore bowel
function following surgery. Positive data from Phase 2 trials of
LB1148 demonstrated safety and tolerability as well as a
statistically significant improvement in return to bowel function
and decrease in length of stay in ICU and hospital compared to
placebo. Palisade Bio believes that its investigational therapies
have the potential to address the myriad health conditions and
complications associated with chronic disruption of the
gastrointestinal epithelial barrier. For more information, please
go to www.palisadebio.com.
Forward Looking StatementsThis communication
contains “forward-looking” statements, including, without
limitation, statements related to the anticipated timing and
results of clinical trials, and other statements related to
Palisade’s development programs. Any statements contained in this
communication that are not statements of historical fact may be
deemed to be forward-looking statements. These forward-looking
statements are based upon Palisade’s current expectations.
Forward-looking statements involve risks and uncertainties.
Palisade’s actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, related to the Company’s ability to
advance its preclinical programs and the uncertain and
time-consuming regulatory approval process. Additional risks and
uncertainties can be found in Palisade Bio’s (formerly known as
Seneca Biopharma, Inc.) Quarterly Report on Form 10-Q for the
quarter ended March 31, 2021. Palisade expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Palisade’s expectations with regard thereto
or any change in events, conditions or circumstances on which any
such statements are based.
Palisade Bio Investor Relations Contact: CORE
IRir@palisadebio.com
Palisade Bio Media Relations Contact: CORE
IRJules Abrahamjulesa@coreir.com917-885-73478
Corporate Contact: Justin Stege,
Ph.D.justin.stege@palisadebio.com
Source: Palisade Bio
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