TAIPEI and SAN DIEGO, Aug. 6,
2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492),
a drug development company focusing on first-in-class therapeutics
for oncology, rare diseases, and infectious diseases, today
announced receipt of a "Study May Proceed" letter from
the U.S. Food and Drug Administration ("FDA") for the
initiation of a Phase I/II clinical study of Silmitasertib
(CX-4945) for the treatment of children and young adults with
relapsed refractory solid tumors.
The principal investigator of this investigator-initiated trial
(IIT), Dr. Giselle Saulnier Sholler,
is an internationally known pediatric hematology-oncology clinician
and researcher. In August 2023, she
was invited to serve as the division chief of Pediatric Hematology
and Oncology at Penn State Health Children's Hospital. She brought
with her the Beat Childhood Cancer Research Consortium, a worldwide
network of more than 55 universities and children's hospitals
dedicated to discovering new therapies and cures for children with
cancer.
The research consortium has enrolled more than 1,800 pediatric
cancer patients in more than 23 trials, and has previously helped a
drug obtain FDA approval for high-risk relapsed neuroblastoma
treatments. This phase I/II study is funded by the Four Diamonds
Foundation, with Senhwa Biosciences providing the investigational
drug, Silmitasertib (CX-4945).
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.