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.
Taiwan’s foreign exchange reserves hit a record high at the end of last month, surpassing the US$600 billion mark for the first time, the central bank said yesterday. Last month, the country’s foreign exchange reserves rose US$5.51 billion from a month earlier to reach US$602.94 billion due to an increase in returns from the central bank’s portfolio management, the movement of other foreign currencies in the portfolio against the US dollar and the bank’s efforts to smooth the volatility of the New Taiwan dollar. Department of Foreign Exchange Director-General Eugene Tsai (蔡炯民)said a rate cut cycle launched by the US Federal Reserve
Handset camera lens maker Largan Precision Co (大立光) on Sunday reported a 6.71 percent year-on-year decline in revenue for the third quarter, despite revenue last month hitting the highest level in 11 months. Third-quarter revenue was NT$17.68 billion (US$581.2 million), compared with NT$18.95 billion a year earlier, the company said in a statement. The figure was in line with Yuanta Securities Investment Consulting Co’s (元大投顧) forecast of NT$17.9 billion, but missed the market consensus estimate of NT$18.97 billion. The third-quarter revenue was a 51.44 percent increase from NT$11.67 billion in the second quarter, as the quarter is usually the peak
The US government on Wednesday sanctioned more than two dozen companies in China, Turkey and the United Arab Emirates, including offshoots of a US chip firm, accusing the businesses of providing illicit support to Iran’s military or proxies. The US Department of Commerce included two subsidiaries of US-based chip distributor Arrow Electronics Inc (艾睿電子) on its so-called entity list published on the federal register for facilitating purchases by Iran’s proxies of US tech. Arrow spokesman John Hourigan said that the subsidiaries have been operating in full compliance with US export control regulations and his company is discussing with the US Bureau of
Pegatron Corp (和碩), a key assembler of Apple Inc’s iPhones, on Thursday reported a 12.3 percent year-on-year decline in revenue for last quarter to NT$257.86 billion (US$8.44 billion), but it expects revenue to improve in the second half on traditional holiday demand. The fourth quarter is usually the peak season for its communications products, a company official said on condition of anonymity. As Apple released its new iPhone 17 series early last month, sales in the communications segment rose sequentially last month, the official said. Shipments to Apple have been stable and in line with earlier expectations, they said. Pegatron shipped 2.4 million notebook
RSS