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Senhwa’s Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Medulloblastoma
2021-12-20

Press by Senhwa Biosciences

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with Medulloblastoma.

The FDA grants ODD status to drugs and biologics that are intended to treat, prevent or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the U.S. ODD affords certain financial incentives to support clinical development, exemption from user fees and the potential for up to seven years of market exclusivity in the U.S. upon marketing approval.

“We are pleased to receive ODD for Silmitasertib for Medulloblastoma, a rare, severe pediatric disease for which there are no approved targeted therapies. ODD represents an important regulatory milestone that has the potential to expedite the clinical development of Silmitasertib, a potent and selective CK2 inhibitor,” said Dr. John  Soong, Chief Medical Officer of Senhwa Biosciences.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium (PBTC, www.pbtc.org), is currently conducting a Phase I/II and Surgical Study of Silmitasertib in both children and adults with recurrent sonic hedgehog (SHH) () driven Medulloblastoma. This study is taking place at the PBTC’s participating member academic medical centers and children’s hospitals across the United States. The PBTC is sponsoring this clinical trial and is funded through the Consortium grant awarded by the US National Institute of Health - Cancer Therapy Evaluation Program (CTEP).

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. In addition to ODD, Silmitasertib was granted Fast Track Designation and Rare Pediatric Disease (RPD) Designation from the US FDA on Aug 17, 2021 and July 6, 2020, respectively. If certain criteria are met with the RPD Designation, Senhwa would be eligible for a transferrable Priority Review Voucher (PRV).  The PRV allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.

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