IRVINE, Calif.--(BUSINESS WIRE)--Immunis Inc., a private biotechnology company developing a novel treatment for age and disease-related immune decline, has formally signed a clinical trial agreement with California Institute of Regenerative Medicine (CIRM) Alpha Stem Cell Clinics Network to initiate STEM-MYO Phase 1/2a clinical trials. The trials will assess the safety and tolerability of Immunis’ immunomodulatory secretome product, IMM01-STEM, in patients with muscle atrophy related to knee osteoarthritis, an inflammatory disease that is a leading cause of disability in elderly adults.
Immune system health gradually declines with age and contributes to an array of degenerative maladies within the body, including muscle atrophy. This age-related muscle atrophy, sarcopenia, in addition to muscle wasting from disuse or disease, negatively affects quality of life. No treatments are available to attenuate muscle loss or enhance muscle regeneration. IMM01-STEM is a novel secretome product composed of natural immunomodulators with efficacious cytoskeletal remodeling properties to address these clinical needs.
“We are excited to have reached this clinical milestone that allows us to begin exploring the potential impact of IMM01-STEM in the treatment of an otherwise untreatable disorder,” says Erin Curry, Director of Medical Affairs at Immunis Inc.
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
About Alpha Stem Cell Clinics
Alpha Stem Cell Clinics 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 Stem Cell Clinics please visit: www.cirm.ca.gov
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
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