ImStem Biotechnology Announces FDA has Lifted the Clinical Hold on the Investigational New Drug Application for IMS001 for the Treatment of Multiple Sclerosis
FARMINGTON, Conn., March 20, 2020 /PRNewswire/ -- ImStem Biotechnology, Inc. (Farmington CT), a biopharmaceutical company pioneering the development of human embryonic stem cell (ESC) derived mesenchymal stem cells (hES-MSC), 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, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. We believe this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. The company 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.
"As an inventor of our proprietary technology, we look forward to building a company whose foundation lies in our science based upon years of pioneering research," said Dr. Xiaofang Wang, Chief Technology Officer of ImStem Biotechnology.
IMS001 is an investigational, allogeneic, hES-MSC product derived from human embryonic stem cell line. IMS001 has demonstrated preclinical immunomodulatory and blood-brain-barrier (BBB) repair activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs. These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest.
About ImStem Biotechnology
ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured in scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The company's mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. And its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem biotechnology Inc. is a privately held company headquartered in Farmington, CT. For more information, visit www.imstem.com.