"This is an important milestone for the development of this potential sickle cell disease therapeutic, and we are pleased that NHLBI researchers were able to play a role in advancing this project from the beginning," said NHLBI Director Gary H. Gibbons, M.D. "NHLBI is dedicated to advancing sickle cell disease research as a strategic priority in an effort to improve the quality of care received by patients."
In less than one year, the team completed the preclinical toxicology, chemistry, manufacturing, controls and regulatory studies necessary to support an investigational new drug (IND) application, which AesRx filed with the FDA. After IND clearance, Aes-103 moved into Phase I clinical trials in healthy volunteers and sickle cell disease patients in 2011 and into a Phase II trial in patients in 2013. The project results also helped AesRx obtain a Massachusetts Life Science Accelerator loan to support development of Aes-103.
"This project may never have reached clinical trials if not for the TRND program and its preclinical drug development expertise and novel approaches," said Stephen Seiler, AesRx's founder and former CEO. "We believe Aes-103 has the potential to be a breakthrough in the treatment of sickle cell disease. TRND's support for AesRx has enabled us to bring that potential closer to realization."
"Acquiring AesRx and this clinical development program is an important opportunity, as it complements Baxter's established relationships and expertise in treating rare and challenging blood disorders," said Ludwig Hantson, Ph.D., president of Baxter BioScience. "This investment reflects our continued focus on addressing high unmet clinical needs for pa
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NIH/National Center for Advancing Translational Sciences (NCATS)