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.
AUSTIN, Texas, December 30, 2020 (Newswire.com) - Direct Biologics, LLC, 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.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with a recently expanded R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of regenerative healing by delivering cutting-edge biologic technologies. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of its extracellular vesicle biologic products through the FDA's investigational new drug application process. For more information, visit http://www.directbiologics.com.
Source: Direct Biologics