CalciMedica announced that its collaborator, St. Jude Children’s Research Hospital, SJCRH, presented data from the initial cohort of the Phase 1/2 CRSPA study of Auxora in asparaginase-induced pancreatic toxicity, AIPT, at the 65th Annual American Society of Hematology, ASH, Meeting & Exposition on Sunday, December 10, 2023, in San Diego, CA. Investigators at SJCRH presented results from the first cohort of the CRSPA study, consisting of nine children with acute lymphoblastic leukemia experiencing asparaginase-associated pancreatitis, also known as AIPT and referred to as AAP in the abstract. Treatment with Auxora, as compared to the historical matched control group, was shown to have the potential to reduce the severity of AIPT in pediatric patients with ALL. Study results showed that Auxora reduced the average number of days patients spent in the hospital from 13.4 to 6.3 days. The need for intensive care unit care was also reduced, with three control patients requiring ICU care compared to one treated patient, and the average number of days in the ICU was reduced from 5 to 3 days. Additionally, no patients in the CRSPA study required TPN, compared to 68.8% in the historical matched control group, who required 27 days of nutritional support on average. Finally, blinded central reading of pancreatic imaging showed a reduction in the development of significant pancreatic necrosis and the severity of acute pancreatitis by CT severity index scoring in patients treated with Auxora compared to the historical matched cohort. Based on these results, investigators have established dose level 1 as the recommended Phase 2 dose of Auxora for children with ALL experiencing AIPT.
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