EXIT COVID-19 has started the enrolment of 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery.
FREMONT, CA: Market-leading innovator and cGMP manufacturer of regenerative medical products, including a full line of extracellular vesicle-based biological products, Direct Biologics, announced the launch of EXIT COVID-19, the company's Phase II, multi-centre clinical trial examining the use of ExoFlo extracellular vesicles to treat COVID-19 related acute respiratory distress syndrome (ARDS). Preclinical studies of these extracellular vesicles secreted by bone marrow-derived mesenchymal stem cells (bmMSCs) revealed that the patients might have the ability to downregulate inflammation and upregulate tissue repair in humans.
"We have pursued a relentless path since April 2020 when the 24 inpatients were treated, and ExoFlo's potential as a therapeutic countermeasure against severe COVID-19 first became clear. Patients in the U.S. deserve safe, innovative therapies that meet the highest standards of value and evidence-based medicine, and our phase II double-blind, placebo-controlled, randomized clinical trial is the next step in that process. It will continue to be my priority to maintain these standards as we investigate the potential benefit of ExoFlo as a treatment for COVID-19 associated ARDS," stated Chief Medical Officer Vik Sengupta, MD.
EXIT COVID-19 has started the enrolment of 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery. ExoFlo is an investigational new drug that has not yet been approved or licensed by the FDA. The extracellular vesicle product is isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). The drug provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
"This signifies an important milestone in the progression of our product platform development to help in the fight against COVID-19," states Joe Schmidt, Co-Founder and President. "This novel therapy has the potential both to improve outcomes for patients and also to reduce overall costs of hospital stays and adjunctive treatments by speeding recovery and reducing the need or length of ICU time."
Direct Biologics, is headquartered in Austin, TX, with a Research and Development facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. "We are excited to start enrolling patients in the study and look forward to seeing the outcomes of this advanced therapy. We are dedicated to bringing to market a novel treatment at an accelerated pace to help patients suffering from this devastating disease," stated Co-Founder and Chief Executive Officer, Mark Adams.
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