Shares of OBI Pharma Inc (台灣浩鼎) yesterday fell by the maximum daily limit of 10 percent to close at NT$613, after the company on Sunday released discouraging results on the second and third-phase clinical trials of a new breast cancer drug, OBI-822.
OBI-822 remains an effective treatment option and the trial’s less promising than expected outcome stemmed from a number of factors, OBI Pharma chairman Michael Chang (張念慈) told an investors’ conference yesterday.
The drug is designed to target Globo H, an oligosaccharide tumor antigen, by triggering the human body’s immune system to generate antibodies that activate cytotoxic T cells to destroy cancer cells, and more than 80 percent of the participants in the trials had generated immune system responses, he said.
Among the participants who showed immune responses, most had made good progress in recovery, while maintaining a safe level of toxicity of the drug.
“About 20 percent of participants did not generate immune responses, and their results should not have been included in the study,” Chang said.
The parameters of the study were set in 2009, and the company elected to go ahead with the trials even though it had discovered flaws in the methodology, he said.
In addition, the study had neglected to select participants based on whether they showed an ample presence of Globo H, Chang said.
Immune responses are not statistically significant without the oligosaccharide, he said.
The flawed design of the study prematurely ruled out many potential participants before they had time to go through the eight-to-nine-week dormant period it is believed to take for the immune responses to develop, he said.
Chang said that he and the company’s other major stakeholders are planning to initiate a share buyback program.
Academia Sinica President Wong Chi-huey (翁啟惠), a close collaborator with the company, said he considers an 80 percent immune response as a statistically successful outcome, in particular among people in the more terminal stages of their diseases, who have diminished immune systems.
The objective of clinical trials is to determine which drugs prove to be effective and the focus should be placed on the outcome of participants who have developed an immune response, Wong said.
Excluding those without an immune response would present a more statistically significant outcome, Wong said, and he urged health authorities to devise new criteria for different treatments.
Yesterday’s plunge in OBI Pharma shares dragged down the biotechnology and medical care sub-index on the Taipei Exchange, which fell 5.17 percent to 178.9 points, the lowest since November last year, with many other high-priced sector leaders also seeing steep declines, TPEX data showed.
Analysts said that they do not expect a catastrophic crash in OBI Pharma share prices, as the company’s backers include the deep-pocketed Runtex Group (潤泰集團).
KEEPING UP: The acquisition of a cleanroom in Taiwan would enable Micron to increase production in a market where demand continues to outpace supply, a Micron official said Micron Technology Inc has signed a letter of intent to buy a fabrication site in Taiwan from Powerchip Semiconductor Manufacturing Corp (力積電) for US$1.8 billion to expand its production of memory chips. Micron would take control of the P5 site in Miaoli County’s Tongluo Township (銅鑼) and plans to ramp up DRAM production in phases after the transaction closes in the second quarter, the company said in a statement on Saturday. The acquisition includes an existing 12 inch fab cleanroom of 27,871m2 and would further position Micron to address growing global demand for memory solutions, the company said. Micron expects the transaction to
Vincent Wei led fellow Singaporean farmers around an empty Malaysian plot, laying out plans for a greenhouse and rows of leafy vegetables. What he pitched was not just space for crops, but a lifeline for growers struggling to make ends meet in a city-state with high prices and little vacant land. The future agriculture hub is part of a joint special economic zone launched last year by the two neighbors, expected to cost US$123 million and produce 10,000 tonnes of fresh produce annually. It is attracting Singaporean farmers with promises of cheaper land, labor and energy just over the border.
US actor Matthew McConaughey has filed recordings of his image and voice with US patent authorities to protect them from unauthorized usage by artificial intelligence (AI) platforms, a representative said earlier this week. Several video clips and audio recordings were registered by the commercial arm of the Just Keep Livin’ Foundation, a non-profit created by the Oscar-winning actor and his wife, Camila, according to the US Patent and Trademark Office database. Many artists are increasingly concerned about the uncontrolled use of their image via generative AI since the rollout of ChatGPT and other AI-powered tools. Several US states have adopted
A proposed billionaires’ tax in California has ignited a political uproar in Silicon Valley, with tech titans threatening to leave the state while California Governor Gavin Newsom of the Democratic Party maneuvers to defeat a levy that he fears would lead to an exodus of wealth. A technology mecca, California has more billionaires than any other US state — a few hundred, by some estimates. About half its personal income tax revenue, a financial backbone in the nearly US$350 billion budget, comes from the top 1 percent of earners. A large healthcare union is attempting to place a proposal before
RSS