May 2022 FDA awards Phase 1/2a clinical trial to study the effects of Immunis’ platform immunomodulatory product STEM on muscular atrophy in patients with knee osteoarthritis
Immunis Announces FDA Clearance and Clinical Site for Phase 1/2a Clinical Trial Investigating Muscle Atrophy
“The completion of this financing round reflects strong asset development, an outstanding team and a focused strategy,” said Dr. Hans S. Keirstead, Chairman of Immunis.
An inevitable consequence of aging is decline of immune system health. Immune system degeneration manifests many degenerative conditions within the body, including muscle atrophy. Mitigating the loss of muscle and improving muscle recovery are unmet medical needs. Immunis’ unique secretome treatment, IMM01-STEM, addresses both medical needs using natural immunomodulators with potent cytoskeletal remodeling properties.
“This is a first-in-sector immunomodulatory secretome product, and Immunis is excited to be entering human clinical testing,” said Dr. Tom Lane, Chief Science Officer of Immunis. “The secretome is all natural, all human and represents a perfectly balanced set of immune modulators in naturally occurring, relevant physiological concentrations.”
About Immunis Inc.
Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The STEM product line leverages Immunis’ leading-edge capabilities in stem cell technology to deliver all natural, all human immune modulators in their natural, relative physiological concentrations.
About STEM-MYO
Immunis’ FDA-awarded Phase 1/2a clinical trial is an open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in elderly participants with muscle atrophy associated with knee osteoarthritis (KOA). Up to 18 patients will be enrolled in the trial and randomly assigned to an IMM01-STEM dose cohort. Treatment will be administered in the form of intramuscular injections twice a week, for four weeks (8 injections total). Male or female patients are eligible for the study if they satisfy the following criteria: (1) 50 to 75 years of age at the time of signing the informed consent, (2) have grade 2 or 3 knee osteoarthritis as defined by Kellgren-Lawrence analyses, (3) have quadricep weakness (<7.5N/kg), (4) can ambulate >50 feet unassisted, (5) are negative for human immunodeficiency virus, hepatitis B surface antigen (HBsAg) and hepatitis C at the Screening Visit and (6) have a body mass index (BMI) of <40kg/m2. For additional information about Immunis’ trial participant qualifications, please visit: https://immunisbiomedical.com/
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