TAIPEI, Taiwan and SAN DIEGO, June 12, 2018 /PRNewswire/ — Senhwa Biosciences Inc. (6492.TT) announced that the company and the Pediatric Brain Tumor Consortium (PBTC, US, www.pbtc.org) have signed a clinical trial agreement to study CX-4945 in the treatment of recurrent Medulloblastoma (MB), a rare and malignant pediatric brain tumor with unmet medical needs.
The PBTC will conduct a Phase I/II and Surgical study of CX-4945 in both children and adults with recurrent SHH medulloblastoma at its participating member academic medical centers and children’s hospitals across the United States (see Table I for a complete list). Objectives of the study include establishing the safety, tolerability, pharmacokinetics and preliminary evidence of activity for CX-4945 in this patient population. This clinical trial will be sponsored by the PBTC and funded thorough the Consortium grant awarded by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
Senhwa’s Chairman, Benny Hu, said research conducted at the Stanford University School of Medicine on Senhwa’s small molecule, CX-4945, determined that the molecule, as a selective CK2 inhibitor, has the potential to treat medulloblastoma.
A comprehensive collaborative plan contributed to bringing about the further cooperation between Senhwa and the PBTC. This is a great opportunity for a Taiwan biotech company to collaborate with the world’s top-tier research and medical teams. Moreover, the trial will be externally funded but also performed in the US’s leading children’s hospitals and cancer centers.
Furthermore, Dr. Tai-Sen Soong, CEO of Senhwa, also pointed out that the development of drugs for children’s brain tumors is particularly difficult due to the blood-brain barrier (BBB), which stops most drugs from entry into the brain. Considering the limited market and the risk of toxicity in children, most pharmaceutical companies have low interest in development drugs for pediatric brain tumors. Now a clinical trial of CX-4945 is going to be launched in the first-tier children’s hospitals and cancer centers, Senhwa is very honored, grateful and genuinely touched by the support from PBTC. Senhwa is looking forward to the clinical progress, and in hope of those who suffer from brain tumors can be benefited in the near future.
This clinical trial is targeting pediatric and adult SHH medulloblastoma, with peak incidence in children <3 and adolescents/adults (>16). SHH is recognized as one of the 4 major sub-groups of medulloblastoma with an estimated 80-100 newly diagnosed cases per year. Senhwa plans to apply for fast track designation to accelerate the drug approval process if promising results come out from the clinical study.
Pediatric Brain Tumor Consortium (PBTC) Full Member Institutions
1. Ann & Robert H. Lurie Children’s Hospital of Chicago
2. Children’s Hospital Los Angeles
3. Children’s Hospital of Pittsburgh
4. Children’s National Medical Center
5. Children’s Healthcare of Atlanta
6. Children’s Hospital Colorado
7. Cincinnati Children’s Hospital Medical Center
8. Lucile Packard Children’s Hospital Stanford
9. Memorial Sloan Kettering Cancer Center
10. NIH-Pediatric Oncology Branch
11. St Jude Children’s Research Hospital
12. Texas Children’s Cancer Center
(footnote: PBTC member institutions, in alphabetical order)
CX-4945 is a first-in-class small molecule drug that inhibits protein Casein kinase 2 (CK2), which plays an important role in the DNA damage repair mechanisms of cancer cells. Due to the complex regulatory mechanisms of CK2, the threshold of technology in drug development is highly demanding. A phase I study showed that CX-4945 achieved clinical benefit as a single agent CK2 inhibitor, demonstrating stable disease and extended duration of treatment in several patients. A combination of CX-4945 with the DNA damaging agents such as gemcitabine (Gemzar) plus cisplatin (Platinol) has been shown to act synergistically to improve the efficacy of anticancer treatments. CX-4945 has been granted Orphan Drug Designation by US FDA in cholangiocarcinoma (CCA) in December 2016.
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