First Patient Dosed in Phase 1 Trial of IMS001 Therapy

ImStem Biotechnology announced that the first patient in its Phase 1 clinical trial for IMS001, an investigational treatment for multiple sclerosis (MS), has been dosed at the Shepherd Center in Atlanta.

The trial (NCT04956744) is recruiting participants with an MS diagnosis ages 18 to 65. More information is available on this link.

“On behalf of our research team, we are excited to have been the first site in the US to dose an MS patient in their ongoing clinical trial with IMS001,” Ben Thrower, MD, of the Shepherd Center, said in a press release.

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IMS001 is an investigational live cell product containing mesenchymal stem cells (MSC) — adult stem cells that have the ability to differentiate into multiple cell types — derived from human embryonic stem cells using a proprietary method developed by ImStem. Using embryonic stem cells as the source for the MSCs allows for less variability and more potency than sourcing cells over traditional adult tissue.

The treatment uses cells from donors and is administered via intravenous (into-the-vein) infusion.

IMS001 has demonstrated in preclinical studies the ability to stabilize an overactive immune system, as well as repair the blood-brain barrier. This leads to its potential therapeutic use in numerous neurological or autoimmune conditions, including MS, where according to ImStem, it has the potential to reduce symptom relapses, reduce disease progression, and encourage disease arrest.

In March 2020, ImStem received approval to begin clinical testing of IMS001 in MS. Now, the company reports that the first patient on their Phase 1 trial has been dosed.

ImStem intends to continue enrollment for the study. The trial’s goal is to assess the safety, tolerability, and efficacy of a single dose of IMS001 in patients with relapsing-remitting, secondary, or primary progressive MS with prior treatment failure with disease-modifying treatments. Treatment with a high and a low dose of the therapy will be analyzed.

“As a scientific advisor to ImStem Biotechnology, it is encouraging to see this [MSC] technology advance into the clinical stage of development where it may fulfill unmet needs for patients with MS,” said Jeffrey Cohen, MD, professor and director of the experimental therapeutics program at Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research.