Intending to treat sarcopenia, the private biotechnology company Immunis has begun a human clinical trial of a stem cell secretome product that affects the immune system. The company’s full press release is included here.
Immunis, Inc., a private biotech company developing an innovative treatment for age and disease-related immune decline, announces its first-in-human injection of IMM01-STEM for its STEM-MYO Phase 1/2a clinical trial. The goal is to assess the safety and tolerability of Immunis’ investigational stem cell secretome product, IMM01-STEM, in patients with muscle atrophy related to knee osteoarthritis, an inflammatory disease contributing to age-related disability. Immunis is actively recruiting patients for the trial in collaboration with the California Institute of Regenerative Medicine (CIRM) Alpha Clinic.
As we age, our immune system health progressively declines, resulting in an array of degenerative diseases, including muscle atrophy. Age-related muscle atrophy, or sarcopenia, combined with muscle wasting from disease or disuse, negatively affects quality of life. Currently, no treatment exists to attenuate this muscle loss or enhance muscle regeneration. IMM01-STEM is a novel, investigational secretome comprised of natural immunomodulators that may address these clinical needs.
“IMM01-STEM underwent intense scientific scrutiny to reach this stage of new drug development. This first-in-human injection marks the starting point for observing IMM01-STEM’s immense potential in humans,” said Erin Curry, PA-C, MPH, Director of Medical Affairs at Immunis.
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. 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/m2), (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 Alpha Clinic
Alpha Clinic is a network of top medical centers in California that specializes in stem cell clinical trials. The Network is successful in providing accelerated delivery of treatments to their patients through strong partnerships between patients, medical providers and clinical trial sponsors. These partnerships leverage industry and academic resources to develop high-quality research and innovative stem cell therapies for patients. For additional information about Alpha Clinic please visit: www.cirm.ca.gov
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 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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