Monday, April 6, 2020
Breaking Medical Device Industry News

AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA Lifted the Hold and Cleared the Investigational New Drug Application for IMS001 for the Treatment of Multiple Sclerosis

Monday, April 6, 2020

Today Agex Therapeutics announced that ImStem Biotechnology, Inc., a biopharmaceutical company pioneering the development of mesenchymal stem cells (hES-MSC) derived from human embryonic stem cells has received notification from the U.S. Food and Drug Administration (FDA) that it has lifted the hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 was derived from the pluripotential cell line designated ESI-053 licensed from AgeX.

“Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies,” stated Dr. Michael D. West, Ph.D., founder, and CEO of AgeX. “This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications.”

IMS001 is a formulation of cells derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal cells (hES-MSC) and through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases. IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. ImStem believes this is the first he’s-MSC based allogeneic cell therapy accepted for a clinical trial by the FDA. ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

“The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created,” said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. “As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development.”

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