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DiscGenics Earns Times Square Recognition for its Injectable Disc Cell Therapy Trial

Company recently treated the first patient in a Phase 3 study evaluating injectable disc cell therapy for lumbar degenerative disc disease.

Photo: DiscGenics.

It may not rival the Camel cigarette man, the “I want my MTV!” campaign, or Coca-Cola’s 3D robotic living brand display in iconic status, but DiscGenics Inc.’s seven-story message in downtown Manhattan this week is historic in its own right.

Nine days after announcing the first patient treatment in a randomized clinical trial of injectable disc cell therapy (IDCT) for degenerative disc disease, Nasdaq marked the milestone with a congratulatory message on the Nasdaq Tower in Times Square on Jan. 22.

“Treating the first patient in our U.S. Phase III clinical trial is a major milestone for DiscGenics and a meaningful step forward in our mission,” DiscGenics Chairman/CEO Flagg Flanagan said. “We’re proud to see this moment recognized on the Nasdaq Tower in Times Square, but what matters most is what it represents—the dedication of our team and the possibility of making a real difference for patients. As we advance this Phase III study, we remain focused on executing with rigor and urgency, so we can help bring a meaningful new option to the many patients who may benefit.”

DGX-A02 is a double-blind, sham-controlled Phase III clinical trial designed to evaluate IDCT’s safety and efficacy in patients with single-level, symptomatic mild-to-moderate lumbar (L3–S1) intervertebral disc degeneration. The prospective, multicenter trial is expected to enroll about 162 subjects and includes a 52-week primary period followed by a 52-week follow-up period (total 104 weeks).

IDCT (Rebonuputemcel) is an investigational, single-injection biologic treatment designed to halt lumbar disc degeneration progression and regenerate the disc from within. The active component of IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, delivered through a viscous carrier. IDCT has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA). IDCT has not been approved by the FDA or any other regulatory authority for any use.

DiscGenics is a privately held, late-stage clinical biopharmaceutical company developing allogeneic, cell-based regenerative therapies for musculoskeletal degeneration. Its lead product candidate, IDCT (rebonuputemcel), is a single-injection biologic therapy designed to halt lumbar disc degeneration progression and regenerate the disc from the inside out. DiscGenics has developed a proprietary, commercial-scale, in-house allogeneic cell manufacturing process and built a cGMP facility at its Salt Lake City, Utah, headquarters.

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