Salt Lake City, UT – September 24, 2019 – 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 the online publication of a study in The Spine Journal [1] that summarizes the results of preclinical testing for Discogenic Cells, the active ingredient in IDCT, DiscGenics’ investigational cell therapy for disc degeneration.
The Spine Journalis a peer-reviewed medical journal covering research related to the spine and spine care, and is the official journal of the North American Spine Society (NASS). With a 5 Year Impact Factor of 3.196, The Spine Journalis one of the ten most widely cited peer-reviewed publications in the field of orthopedics.
The manuscript, titled “In Vitro and In Vivo Evaluation of Discogenic Cells, An Investigational Cell Therapy for Disc Degeneration,” demonstrates that intradiscal injection of Discogenic Cells may be a viable treatment for human degenerative disc disease (DDD), citing that the cells produce extracellular matrix that may rebuild the depleting tissue within degenerative discs, and pose no significant safety concerns.
Discogenic Cells are biomedically engineered progenitor cells derived from donated adult human intervertebral disc tissue to uniquely address the complex environment of the degenerated disc. IDCT is a homologous, allogeneic, injectable disc cell therapy that utilizes Discogenic Cells to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate DDD.
The objective of the studies presented was to evaluate the characteristics, mode of action, and in vivoefficacy and safety of Discogenic Cells before human clinical testing. Discogenic Cells generated from different adult human donors were evaluated in vitrofor surface marker expression profile, matrix deposition and tumorigenic potential. Then, in vivocharacterization of Discogenic Cells was performed through subcutaneous implantation and intradiscal injection of human Discogenic Cells in nude mice and rabbit disc degeneration models, respectively.
“Our preclinical experience with Discogenic Cells was very compelling, as it indicated the ability of IDCT to safely normalize disc architecture and restore disc height in animal models,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “If IDCT demonstrates similar results in humans, we believe the outcome could be a reduction in pain and disability, potentially revolutionizing the way millions of patients suffering from the debilitating effects of chronic low back pain are treated. Importantly, these studies serve as the foundation for our ongoing clinical program evaluating IDCT for DDD and played a significant role in IDCT being granted Fast Track designation last month by the U.S. Food and Drug Administration (FDA) as a potential treatment option for chronic low back pain.”
Human clinical testing of Discogenic Cells combined with a sodium hyaluronate carrier (IDCT) is ongoing in parallel randomized, controlled, double-blinded studies in the United States (clinicaltrials.gov identifier NCT03347708) and Japan (clinicaltrials.gov identifier NCT03955315).
In the U.S., IDCT is being evaluated under an investigational new drug (IND) allowance and Fast Track designation granted by the FDA, and will be regulated as a drug-biologic through a therapeutics biologics license application (BLA). The Company recently announced that its U.S. study of IDCT has passed the halfway mark, with the first 30 subjects having been safely treated. For more information on the U.S. study, please visit: https://clinicaltrials.gov/ct2/show/NCT03347708.
In Japan, clinical study of IDCT is supported by a Clinical Trial Notification (CTN) approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). For more information on the Japanese study, please visit: https://clinicaltrials.gov/ct2/show/NCT03955315.
Reference
1. Silverman L. et al (2019).In vitro and in vivo evaluation of discogenic cells, an investigational cell therapy for disc degeneration. The Spine Journal. DOI: https://doi.org/10.1016/j.spinee.2019.08.006.
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.