The Neurology Center and the Innovation and Research Center of Hualien Tzu Chi Hospital, in collaboration with Everfront Biotech Inc., have been working for many years on the development and clinical trials of Cerebraca® Wafer, a targeted new drug for malignant brain tumors. Their work on “Cerebraca Wafer treatment for recurrent malignant brain tumors that are resistant to standard treatment” has been recognized with National Innovation Award – Clinical Innovation.
The Neurology Center and the Innovation and Research Center of Hualien Tzu Chi Hospital, in collaboration with Everfront Biotech Inc., have been working for many years on the development and clinical trials of Cerebraca® Wafer, a targeted new drug for malignant brain tumors. Their work has not only exceeded the duration of current clinical drug Gliadel® Wafer (BCNU), but also set a new record in overall survival rate, with a 100% six-month progression-free survival rate. On December 3rd, their work on “Cerebraca® Wafer treatment for recurrent malignant brain tumors that are resistant to standard treatment” was recognized with the Clinical Innovation Award of the National Innovation Awards.
According to statistics from the American Cancer Society (ACS) and the Central Brain Tumor Registry of the United States (CBTRUS), it is estimated that about 20,000 new cases of brain tumors are diagnosed each year. In Taiwan, there are about 400 new cases of malignant glioma each year. Among them, malignant glioblastoma is a highly malignant primary brain tumor that can grow up to 16 times in one month. The recurrence rate after surgical removal of the tumor is high, often requiring patients to repeatedly receive treatment at the hospital.
The current conventional treatments for malignant brain tumors in medicine, including surgery, radiation therapy, and chemotherapy, have very limited effectiveness. The Shinn-Zong Lin team at Hualien Tzu Chi Hospital has been researching and developing new drugs for malignant brain tumors for more than a decade. BP is a multi-targeted small molecule drug that can reduce the resistance to temozolomide (TMZ) and the immune cold lesion caused by the expression of Programmed Death-Ligand 1 (PD-L1). It is combined with a biodegradable polymer, poly(anhydride), to form the Cerebraca® wafer, which has the characteristics of drug slow-release and long-lasting effects. It effectively inhibits the growth of brain tumor cells, and has low toxicity to normal cells. Cerebraca® Wafer has obtained multiple national patents for combating human glioblastoma (GBM) and has been recognized with the National Innovation Award. It has also been licensed to Everfront Biotechnology Inc.
Six years ago, commissioned by Everfront Biotech Inc., the team from Hualien Tzu Chi Hospital, in collaboration with the neurosurgery team from Tri-Service General Hospital, carried out clinical trials for the development of the new drug Cerebraca® wafer for the treatment of malignant brain tumors. The research results were published in the international cancer specialty journal Cancers in March of this year.
Since 2016, the phase I clinical trials was initiated to determine the safety of the anti-malignant brain tumor drug Cerebraca® Wafer. It then proceeded to the phase II , Phase IIa, which enrolled a total of ten patients. The results showed that recurrent malignant brain tumor patients who received low-dose Cerebraca® Wafer (BP) had a median overall survival rate (OS) of 12 months, which is longer than the 6.4 months of Gliadel® Wafer (BCNU). Moreover, patients with malignant brain tumors who received high-dose Cerebraca® Wafer had a median overall survival rate exceeding 17.4 months.
The progression-free survival rate (PFS) at 6 months reached 100%. Dr. Liu Jing-An, Deputy Technical Director of Tzu Chi Innovation Research Institute, pointed out that in vitro studies using primary cells from patient tumor tissue showed that BP had a half-inhibitory concentration (IC50) on tumor stem cells of 400uM, which is at least five times lower than that of carmustine (BCNU IC50 > 2000uM).
In 2019, the targeted drug Cerebraca® wafer, which has entered phase II clinical trials, won the National Innovation Award for a second time, receiving the “Innovation Progress Award”. The research, drug formulation development and manufacturing, IRB application and execution of clinical trials for Cerebraca® wafer were all carried out by a local team in Taiwan. The team was recognized at the Clinical Innovation Awards ceremony on December 3rd this year, which was attended by Superintendent Shinn-Zong Lin, Director of the Neurology Science Center Tsung-Lang Chiou, Deputy R&D Director of Tzu Chi Innovation Research Institute Hong-Zhi Harn, Deputy Technical Director Jing-An Liu, and Chairman of Everfront Biotech Inc. Pei-Wen Chiou, who jointly created a new history of research and application for locally developed malignant brain tumor drugs in Taiwan.