SynCore Biotechnology Co (杏國新藥) is planning an interim analysis of its pancreatic cancer treatment, SB05PC, later this month to determine the drug’s safety and efficacy.
The company is conducting a phase III trial for the drug in Taiwan, the US, France, Hungary, South Korea, Russia and Israel, SynCore general manager Su Muh-hwan (蘇慕寰) told the Taipei Times on Thursday by telephone.
The company aims to use the drug as a second-line treatment in combination with gemcitabine, a chemotherapy medication, for people who do not respond to first-line medicine Folfirinox, a combination of leucovorin, fluorouracil, irinotecan and oxaliplatin.
Participants in the phase III trial are randomly separated into two groups, with one injected with only gemcitabine and the other tested with a combination of gemcitabine and SB05PC, Su said.
As SB05PC is designed to prolong a person’s life, SynCore cannot enter into interim analysis of the drug until half of enrolled participants pass away, he said.
Now that 101 of the 200 participants have died, SynCore can collect data and conduct an interim analysis to evaluate if people survive longer than those who have not taken the drug, he said.
During the phase II trial, participants who took SB05PC and gemcitabine had an average overall survival period of nine months, compared with 7.4 months for those who only received gemcitabine, Su said.
Overall survival is the length of time from the start of treatment to a person’s death, he added.
As for the drug’s progression-free survival (PFS) — the length of time during and after treatment that the disease does not get worse — participants who took SB05PC and gemcitabine had an average PFS period of 4.9 months, compared with 3.5 months for those only taking gemcitabine, he said.
SynCore had planned to enroll 218 participants, but the US Food and Drug Administration has approved adjusting that number based on the outcome of the interim analysis, Su said.
The company plans to end enrollment for the phase III trial by the end of this year and complete the trial by the end of next year on the expectation that participants would survive from seven to nine months, he said.
If everything goes smoothly, SynCore plans to apply to the US regulator for marketing approval of the drug in 2022, he added.
SynCore in February delayed its original plan to begin another phase III trial of SB05PC in China as many patients could not go to hospitals due to a lockdown amid a COVID-19 outbreak.
Su said that the firm plans to delay the clinical trial to August.
Shares of contract chipmaker Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) came under pressure yesterday after a report that Apple Inc is looking to shift some orders from the Taiwanese company to Intel Corp. TSMC shares fell NT$55, or 2.4 percent, to close at NT$2,235 on the local main board, Taiwan Stock Exchange data showed. Despite the losses, TSMC is expected to continue to benefit from sound fundamentals, as it maintains a lead over its peers in high-end process development, analysts said. “The selling was a knee-jerk reaction to an Intel-Apple report over the weekend,” Mega International Investment Services Corp (兆豐國際投顧) analyst Alex Huang
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) is expected to remain Apple Inc’s primary chip manufacturing partner despite reports that Apple could shift some orders to Intel Corp, industry experts said yesterday. The comments came after The Wall Street Journal reported on Friday that Apple and Intel had reached a preliminary agreement following more than a year of negotiations for Intel to manufacture some chips for Apple devices. Taiwan Institute of Economic Research (台灣經濟研究院) economist Arisa Liu (劉佩真) said TSMC’s advanced packaging technologies, including integrated fan-out and chip-on-wafer-on-substrate, remain critical to the performance of Apple’s A-series and M-series chips. She said Intel and Samsung
POWER BUILDUP: Powered by Nvidia’s B200 Blackwell chips, the data center would support MediaTek’s computing power demand and business growth, the company said Smartphone chip designer MediaTek Inc (聯發科) yesterday launched a new artificial intelligence (AI) data center with a maximum capacity of 45 megawatts to meet its rising demand for computing power required to develop new advanced chips for AI applications. The company has completed the first-phase computing power buildup at the data center in Miaoli County’s Tongluo Township (銅鑼), providing 15 megawatts of capacity to support its research and development (R&D) capabilities, despite an industrywide shortage of key components, MediaTek said. Supply constraints have plagued a wide range of key components, including memory chips, solid-state drives, power supply units and central
TRANSITION: With the closure, the company would reorganize its Taiwanese unit to a sales and service-focused model, Bridgestone said Bridgestone Corp yesterday announced it would cease manufacturing operations at its tire plant in Hsinchu County’s Hukou Township (湖口), affecting more than 500 workers. Bridgestone Taiwan Co (台灣普利司通) said in a statement that the decision was based on the Tokyo-based tire maker’s adjustments to its global operational strategy and long-term market development considerations. The Taiwanese unit would be reorganized as part of the closure, effective yesterday, and all related production activities would be concluded, the statement said. Under the plan, Bridgestone would continue to deepen its presence in the Taiwanese market, while transitioning to a sales and service-focused business model, it added. The Hsinchu
RSS