Jasper Therapeutics Announces Plans for Registrational Study of JSP191 in Older Patients with Myelodysplastic Syndromes or Acute Myeloid Leukemia Undergoing Hematopoietic Cell Transplantation after Type C FDA Meeting
Based on positive feedback provided by FDA on key clinical design details Jasper plans to initiate registrational studies in AML and MDS patients
Excerpt from the Press Release:
REDWOOD CITY, Calif., April 28, 2022 (GLOBE NEWSWIRE) — Jasper Therapeutics, Inc., (NASDAQ: JSPR) a biotechnology company focused on hematopoietic stem cell therapies, today announced that after discussion with the FDA the company plans to initiate a registrational study of JSP191 as a targeted, non-toxic conditioning agent in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation.
The recent discussion with the FDA included review of the trial comparator arm, population, size, statistical assumptions and primary endpoints. The company agreed with the FDA to submit a trial protocol which is currently being finalized based on agency input. No additional studies were identified as needed prior to start of a potential registrational studies in either MDS or AML patients.
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