NewcelX Ltd. (NASDAQ:NCEL), a regenerative medicine company, on Wednesday announced the submission of a Pre-IND briefing package to the U.S. Food and Drug Administration (FDA) for NCEL-101.
NCEL-101 is the company's flagship stem cell-derived islet replacement therapy, designed as a scalable, "off-the-shelf" treatment to restore functional insulin production in patients with Type 1 Diabetes.
The submission supports a proposed First-In-Human clinical trial for the company's type 1 diabetes treatment program.
"The Pre-IND meeting for NCEL-101 is a pivotal milestone that underscores our commitment towards a potential cure for T1D," said Ronen Twito, Executive Chairman and CEO of NewcelX.
FDA Submission And Trial Plans
