Samumed announced that the Food and Drug Administration (FDA) granted Orphan Drug Designation to SM08502 for the treatment of pancreatic cancer

SM08502 is an oral small-molecule Wnt pathway inhibitor that may potentially attenuate the expression of genes that control differentiation and proliferation of tumor cells. Currently, SM08502 is being evaluated in a Phase 1, open-label, multicenter, dose escalation study (NCT03355066) in 42 adult patients with advanced solid tumors for whom standard therapy is not available for their stage of diagnosis. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered SM08502 given once daily for 28 consecutive days for up to 6 cycles. Secondary outcome measures include tumor response and change in expression of Wnt pathway-related genes.

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“The FDA ODD designation for SM08502 is an important regulatory milestone and highlights the importance of finding treatments for a significant unmet need in pancreatic cancer,” said Dr. Yusuf Yazici, Chief Medical Officer of Samumed.

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