Two-Year Clinical Data for DiscGenics's Progenitor Cell Therapy for Lumbar Disc Degeneration to Be Presented at NASS 2022
SALT LAKE CITY, Oct. 11, 2022 /PRNewswire/ -- DiscGenics, Inc., 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 Matthew F. Gornet, MD, Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, will present two-year follow-up data from the Company's first-in-human clinical study of its allogeneic discogenic progenitor cell therapy (IDCT) for lumbar disc degeneration at the North American Spine Society (NASS) 37th Annual Meeting to be held October 12 – 15, 2022 at McCormick Place West in Chicago.
DiscGenics previously announced the primary efficacy endpoint of the study was achieved with statistically significant improvement in low back pain observed in the high dose IDCT group at the one-year timepoint. High dose IDCT also produced clinically meaningful, statistically significant improvements in function and quality of life by 12 weeks following intradiscal injection with durability sustained at the one-year interim readout.
Dr. Gornet will present final two-year clinical data for three key patient-reported outcome measures of pain, function, and quality of life, as well as MRI results across four study groups: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and saline placebo (n=10).
"We are thrilled to have Dr. Gornet, a world-renowned spine surgeon, present this data," said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. "Dr. Gornet was the highest enroller in our study and provides tremendous perspective on the IDCT data given his years of surgical experience and clinical trial involvement in concert with SPIRITT Research in St. Louis."
The study is an FDA-approved, prospective, randomized, double-blinded, controlled, multicenter study designed to evaluate the safety and preliminary efficacy of IDCT for the treatment of symptomatic lumbar degenerative disc disease versus vehicle and saline controls. For more information on the study, visit: https://clinicaltrials.gov/ct2/show/NCT03347708.
Dr. Gornet's presentation will take place on Wednesday, October 12 at 1:06PM Central Time during the Lumbar Degenerative Pathology Abstract Presentations in Room W471ab.
DiscGenics is a sponsor of NASS 2022 and will host Booth# 5040 in the Exhibit Hall.
In attendance from DiscGenics will be Flagg Flanagan, Chief Executive Officer and Chairman, Dr. Kevin Foley, Chief Medical Officer, Bob Wynalek, Chief Operating and Commercial Officer, and Lindsey Saxon, Communications and Business Development.
DiscGenics is a privately held, clinical-stage biopharmaceutical company developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics's first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, mild to moderate lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a unique progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. 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 has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain. For more information, visit discgenics.com.
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SOURCE DiscGenics, Inc.