The expanded Access Program provides a pathway for patients to gain access to treatment with ExoFlo outside of the active Phase II research clinical trial.
Direct Biologics, announced today that the first patient has been treated under its expanded access protocol for ExoFlo Infusion Treatment for COVID-19 Associated ARDS (EXIT COVID-19).
“The Phase II trial is actively enrolling patients at several sites nationally. It has met several key milestones and is nearing completion,” states Co-Founder and Chief Executive Officer, Mark Adams. “We look forward to sharing our results and hopefully proceeding to Phase III very soon.”
The expanded access protocol is an open label study to treat patients who often have more advanced disease under a “compassionate use” application.
“The expanded access gives us an opportunity to treat very sick patients who do not have other meaningful options,” notes Joe Schmidt, Co-Founder and President. “It also enhances our ability to treat patients at additional hospitals and therefore communities in need across the country.”
Chief Medical Officer, Vik Sengupta, MD, adds, “We at Direct Biologics are grateful for every opportunity to help these additional patients in critical need of treatment.”
This study is under the same IND application utilizing bone marrow-derived extracellular vesicles to treat COVID-19-associated ARDS. Extracellular vesicles secreted by bone marrow-derived mesenchymal stem cells (bmMSCs) have been studied extensively in preclinical studies of lung disease and inflammation and are notable for their ability to downregulate inflammation and upregulate tissue repair.
Physicians can learn more at clinicaltrials.gov and may request access for a patient by emailing firstname.lastname@example.org. Requests for expanded access to ExoFlo must be made by a licensed U.S. treating physician.
ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication.
Source – PR Newswire