Aegle Therapeutics receives IND clearance from FDA for stem cell-derived extracellular vesicle therapy

Aegle Therapeutics Corporation, a regenerative medicine company isolating extracellular vesicles (“EVs”) from allogeneic bone marrow derived mesenchymal stem cells (“MSCs”) to treat severe dermatological conditions, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s first Investigational New Drug (IND) application to begin clinical trials in burn patients. Aegle expects to initiate a Phase 1/2a clinical trial of AGLE-102 for the treatment of severe burn patients in late 2018.

“We are excited to be moving our EV therapy into the clinic to treat burns, an indication with a substantial unmet medical need. We believe this product has the potential for functional regeneration and organization of complex tissue structures that can enhance healing, reduce scarring, minimize contraction and improve overall cosmesis,” said Evangelos Badiavas, M.D., PhD, Aegle’s Founder and Chief Scientific Officer. “Currently, patients with burns suffer scarring, disfigurement, loss of mobility and chronic pain. There’s a real need for better therapies.”

Aegle’s proprietary and innovative EV therapy involves the isolation of extracellular vesicles secreted by allogeneic bone marrow derived mesenchymal stem cells. “The clearance of this IND is an critical milestone for the company as we advance AGLE-102 into the clinic where we hope to demonstrate a means of harnessing the regenerative healing power of stem cells without using the cells as therapy,” said Shelley Hartman, Chief Executive Officer of Aegle. “This achievement is an important step as the company launches a Series A capital raise in 2018 to fund its clinical development.”

The Phase 1/2a study will evaluate the safety of extracellular vesicle therapy in severe second degree burn patients. The study is an open label dose escalation protocol that will enroll patients at several sites in the United States.

Source – PR Web

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