As we age, we experience a gradual decline in immune system function and the production of beneficial cellular secretions, which contributes to an array of degenerative illnesses within the body, including muscle atrophy. Muscle atrophy is also a major contributor to knee osteoarthritis, an inflammatory disease that is a leading cause of disability in elderly adults. There are currently no treatments to attenuate muscle loss or to enhance muscle regeneration. Immunis created an investigational new drug composed of natural immunomodulators to address such clinical needs. Immunis’ investigational secretome product is injected into the quadriceps muscles, with the ultimate goal of alleviating the knee pain and stiffness for individuals with knee osteoarthritis, and the need for associated surgeries.
Immunis’ clinical trial is running in Southern California and is seeking patients to enroll. If you are between the ages of 50-75 with muscle atrophy associated with knee osteoarthritis, please contact us via our website at immunisbiomedical.com or call (949) 266-2501.
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 a 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: www.immunisbiomedical.com
About Immunis Inc.
Immunis Inc is a private biotechnology company developing a novel immunomodulatory secretome productfor the various manifestations of age and disease-related immune decline. The STEM product line leverages Immunis’ leading-edge capabilities in stem cell technologies to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis’ IMM01-STEM Phase 1/2a trial please visit: www.immunisbiomedical.com
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