First Utahns treated in nationwide FDA-allowed clinical study of locally developed cell therapy for chronic low back pain

SALT LAKE CITY, July 10, 2019 /PRNewswire/ -- DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).

The treatments took place at The SMART Clinic, where the study is managed by Physicians' Research Options, LLC (PRO®), a Clinical Research Company that is one of 14 clinical sites across the U.S. participating in the U.S. Food and Drug Administration-allowed trial. The clinical study, which passed its initial planned safety review earlier this year, is designed to evaluate the safety and preliminary efficacy of IDCT, a homologous and allogeneic cell therapy, in the treatment of mild to moderate DDD.

DDD is a chronic, progressive and painful condition that affects approximately one-quarter of adults in the U.S. at a given time. In the earlier stages of DDD, current treatment options are limited to physical rehabilitation and pain management approaches, such as opioid use, that are typically not intended for long-term use. In fact, individuals suffering from chronic low back pain, such as DDD, account for nearly 60% of prescription opioid usage in the U.S.¹ Prescription opioids are also the main driver of overdose deaths involving opioids in Utah, accounting for nearly 70 percent of the 456 opioid overdose deaths in the state in 2017.² If proven effective, IDCT could be a vital tool in curtailing opioid addiction among those who suffer from this debilitating condition.

"We're thrilled to be participating in the clinical evaluation of IDCT," said Angela Krull, M.D. of The SMART Clinic and the clinic's principal investigator for DiscGenics' IDCT trial. "The SMART Clinic is committed to changing the way spine conditions are managed in Salt Lake City and throughout Utah, and we believe that this potentially regenerative, non-surgical therapeutic option could have a significant impact on our patients with DDD."

The SMART Clinic's President and Co-founder, Scott Adelman, M.D., and Co-founder and Fellowship Program Director, Michael Giovanniello, M.D., are also participating in the clinical study. 

DiscGenics began developing IDCT at its laboratories in University of Utah Research Park and last month moved into a new research and development facility near the Northwest Quadrant, as recently announced by the Salt Lake City Department of Economic Development.

"Utah has a great pool of STEM-trained professionals and we've built an incredible team that leverages the expertise of local talent to support our preclinical and clinical development," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. "Developing IDCT has been a true labor of love for the team here in Salt Lake and we are so pleased to be bringing it back home where we have the potential to not only make a significant impact on the health and wellness of our neighbors suffering from chronic low back pain, but to also play a small role in combatting the opioid crisis in our own backyard."

To learn more about DiscGenics and IDCT, please visit DDDtrial.com.

About The SMART Clinic
Founded in 1995, The SMART Clinic is a physician owned private practice located in Draper, Utah. Specializing in the cutting-edge conservative management of spine and sports injuries, The SMART Clinic is respected as the most comprehensive, minimally invasive independent spine and sports care clinic in the area. Physicians draw attention locally, nationally and internationally as industry leaders for the training and implementation of novel innovations in spine and nonoperative sports care. Partners Michael Giovanniello MD, Scott Adelman MD and Angela Krull MD share a common vision for obtaining superior outcomes. All patients are exclusively under physician management. The responsible integration of restorative and regenerative therapies is a priority in this rapidly expanding industry. For more, visit www.theSMARTclinic.com.

About DiscGenics
DiscGenics is a privately held, clinical stage biotechnology 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, visit www.discgenics.com.

References
1. Hudson, T., et al. Epidemiology of Regular Prescribed Opioid Use: Results from a National, Population-Based Survey. J Pain Symptom Manage. 2008 Sep;36(3):280-8.
2. National Institute on Drug Abuse. Utah Opioid Summary. Revised March 2019.
https://www.drugabuse.gov/opioid-summaries-by-state/utah-opioid-summary.  

SOURCE DiscGenics, Inc.