DiscGenics Completes Patient Enrollment in Japanese Clinical Study of Cell Therapy for Disc Degeneration as US Study Achieves One-Year Milestone
PR89219
DiscGenics Completes Patient Enrollment in Japanese Clinical Study of Cell Therapy for Disc Degeneration as US Study Achieves One-Year Follow-up Milestone
SALT LAKE CITY and TOKYO, April 27, 2021 /PRNewswire=KYODO JBN/ --
DiscGenics, Inc. ( https://www.discgenics.com/ ), a clinical stage
biopharmaceutical company focused on developing regenerative cell-based
therapies that alleviate pain and restore function in patients with
degenerative diseases of the spine, today announced that it has completed
enrollment in its Japanese safety study of IDCT, an allogeneic, injectable
Discogenic Cell therapy for lumbar disc degeneration, a major cause of chronic
low back pain.
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This Japanese 38-subject trial is being conducted at seven sites across the
Country and passed the first of two planned mid-trial safety reviews (
) by an Independent Data Monitoring Committee (IDMC). All treated subjects will
be observed and evaluated for safety, primary efficacy, and secondary outcome
measures for a period of six months, at which time another IDMC review will be
completed. Per the study protocol, subjects will continue to be followed for a
six-month extension period.
"Disc degeneration is a significant unmet medical need among Japan's aging
population, and I am pleased to be participating in the clinical evaluation of
IDCT as a potential cell therapy to treat this condition," said Dr. Daisuke
Sakai, Associate Professor at the Department of Orthopaedic Surgery at Tokai
University School of Medicine in Kanagawa, and the study's principal
investigator. "In preclinical observations of IDCT's human Discogenic Cells in
a canine disc degeneration model, I observed their ability to stop disc height
degeneration while improving the structure of the intervertebral disc. If
similar results are achieved in humans, the result could be reduced pain and
disability associated with disc degeneration."
This prospective, randomized, double-blinded, sham-controlled, multicenter
clinical study is designed to evaluate the safety and preliminary efficacy of
IDCT in patients with symptomatic, single-level, mild to moderate lumbar disc
degeneration. Subjects who met all eligibility criteria were randomized to one
of three treatment cohorts. Primary outcome measures include safety and
reduction in pain. Secondary outcome measures include reduction in disability
and radiographic improvement.
In Japan, IDCT is being investigated under a Clinical Trial Notification (CTN)
(
) through the Pharmaceuticals and Medical Devices Agency (PMDA). For more
information, please visit https://clinicaltrials.gov/ct2/show/NCT03955315.
Concurrently in the U.S., DiscGenics is conducting an ongoing prospective,
randomized, double-blinded, vehicle- and placebo-controlled, multicenter
clinical trial of IDCT. All currently enrolled subjects have completed their
one-year study visits in our U.S. clinical study of IDCT for lumbar disc
degeneration. The study has a one-year extension period, so subjects will
continue to be evaluated for safety, primary efficacy, and secondary outcome
measures at two additional study visits over the coming year. Through this
study, IDCT is being evaluated under an investigational new drug (IND)
application through the U.S. Food and Drug Administration (FDA) and will be
regulated as a biologic through the Center for Biologics Evaluation and
Research (CBER). The U.S. study completed enrollment in Q1 2020, passed all
three planned mid-trial safety reviews (
) and has commenced its second year of patient follow-up. For more information,
please visit https://clinicaltrials.gov/ct2/show/NCT03347708.
"The achievement of patient enrollment in Japan and our one-year follow-up in
the U.S. represent significant milestones for our company and are two very
important steps in the development of this potentially regenerative solution
for patients suffering from pain associated with disc degeneration," said Flagg
Flanagan, Chief Executive Officer and Chairman of the Board of Directors for
DiscGenics. "We are deeply appreciative of the commitment the study
investigators and hospitals have shown in helping us get to this critical stage
and are looking forward to successful completion of both studies."
About IDCT
IDCT is a homologous, allogeneic, injectable cell therapy that utilizes
proprietary Discogenic Cells, which are biomedically engineered progenitor
cells that have been derived from intervertebral disc tissue. Discogenic Cells
are reproducibly manufactured in a highly controlled environment under current
good manufacturing practices (cGMP) and subjected to extensive testing
throughout production and prior to use, including identity, purity, potency and
safety. The final product is cryopreserved and maintained as individual
"off-the-shelf" doses for administration via percutaneous injection in an
out-patient setting.
About Disc Degeneration
Disc degeneration is a painful, chronic and progressive disease that is
characterized by inflammation and breakdown of extracellular matrix within the
intervertebral disc. The condition is estimated to affect more than one million
people, including 200,000 patients needing surgical intervention every year in
Japan. Current treatment options for disc degeneration are limited to physical
rehabilitation programs and pain management, in the earlier stages. In the more
advanced stages, oftentimes a patient's only option is surgical intervention to
remove the painful disc(s), fuse two or more vertebral bones together and/or
replace bone or tissue altogether. However, back surgeries often have limited
success and may result in subsequent adjacent level degeneration.
About DiscGenics
DiscGenics is a privately held, clinical stage biopharmaceutical company
focused on developing regenerative cell-based therapies that alleviate pain and
restore function in patients with degenerative diseases of the spine. As the
only company in the world to develop an allogeneic cell therapy derived from
intervertebral disc cells to treat diseases of the disc, DiscGenics believes it
has a unique opportunity to harness the restorative potential of the human body
to heal millions of patients suffering from the debilitating effects of back
pain. DiscGenics' first product candidate, IDCT, is a homologous, allogeneic,
injectable cell therapy that utilizes biomedically engineered progenitor cells
derived from intervertebral disc tissue, known as Discogenic Cells, to offer a
non-surgical, potentially regenerative solution for the treatment of patients
with mild to moderate degenerative disc disease. For more information, visit
discgenics.com (
).
SOURCE DiscGenics, Inc.
CONTACT: Media Contact, Lindsey Saxon, lindsey@discgenics.com, Colin Novick,
colin.lee.novick@cj-partners.com
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