TAIPEI, July 11,
2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx:
6492), announced IND Submission to US FDA for the Phase I/II study
of Silmitasertib (CX-4945) in combination with chemotherapy in
children and young adults with relapsed refractory solid tumors.
This investigator-initiated trial (IIT) will be conducted by the
Penn State Health Children's Hospital and the prestigious Beat
Childhood Cancer Research Consortium, a group of over 50
universities and children's hospitals, based at Penn State College of Medicine in Hershey, Pa., that offers a worldwide network
of pediatric cancer clinical trials. The funding is sponsored by
the Four Diamonds Foundation, with Senhwa Biosciences providing the
investigational drug, Silmitasertib (CX-4945).
The clinical trial is conducted in two phases: the first phase
focuses on establishing the safety and dosage of Silmitasertib
(CX-4945) in pediatric patients with relapsed or refractory solid
tumors, while the second phase evaluates its efficacy and potential
as a novel treatment option.
As high CK2 activity is noted across several pediatric cancers,
including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma,
osteosarcoma, medulloblastoma, and liposarcoma. Recent study has
shown that CK2 is one of the key kinases that is essential for
maintaining the stabilization of MYCN protein, the oncogenic driver
in neuroblastoma. In view of the anti-tumor activity of CK2
inhibitor, the Beat Childhood Cancer Research Consortium at The
Pennsylvania State University regards
Silmitasertib (CX-4945) high therapeutic potential of treating
pediatric cancers.
Neuroblastoma is the most common type of solid malignant tumor
in children, aside from brain tumors and lymphomas. Over 90% of
cases are diagnosed before the age of 5. 70% of patients already
have metastatic disease by the time symptoms appear, and the
20-year survival rate is only around 30%. In the US, there are
700-800 new cases each year, accounting for about 6% of childhood
cancers, meeting the definition of a rare disease.
Senhwa Biosciences is planning to apply for Orphan Drug
Designation (ODD) and Rare Pediatric Disease Designation (RPD) for
Silmitasertib (CX-4945) for the treatment of neuroblastoma. If
these designations are granted and the drug is successfully
commercialized, the company would obtain a Priority Review Voucher
(PRV). The holder of a PRV can designate any future human drug
application to receive priority review, potentially shortening the
review time to 6 months, which could accelerate the timeline for
the company (or its partners) to bring other products to
market.
The clinical trial design also includes Ewing's sarcoma and
osteosarcoma, which are common pediatric bone cancers with poor
prognoses, representing unmet medical needs.
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SOURCE Senhwa Biosciences, Inc.