Taiwan has developed a clinical trial of new anti-breast cancer drugs or needs to be redesigned
Taiwan has developed a clinical trial of new anti-breast cancer drugs or needs to be redesigned
February 23, 2016 Source: Sohu Health
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];According to foreign media reports, biotech stocks Wang Haoding held a press conference on blinding yesterday. Chairman Zhang Nianci interpreted the results optimistically, saying that this is a "very successful blinding". However, the market interpretation is not so optimistic.
Taiwan's Hao Ding announced the results of the anti-milk cancer drug OBI-822 blindness yesterday. The primary efficacy index (Primary Endpoint) did not reach statistical significance, but Zhang Ningci, chairman of Haoding, interpreted the success of “unexpected and broken glasses†The market interprets as “not passingâ€; experts believe that the new anti-breast cancer drug OBI-822 has been scientifically proven effective, but clinical trials may have to be redesigned, which is bound to delay the time to market.
OBI-822, a new anti-milk cancer drug, is an anti-cancer vaccine developed by Weng Qihui with sugar molecular technology, which induces antibodies produced by the human immune system and destroys cancer cells. Taiwan Academia Sinica transferred this discovery technology to Taiwan Haoding, prepared OBI-822 vaccine, started Taiwan clinical trial II/III in December 2012, and conducted a double-blind trial of the fourth metastatic breast cancer patient. In June, the blinding results will be published in the American College of Cancer Medicine and the New England Journal of Medicine.
Hao Ding and the academic circles and markets can be said to be "a blindness and a statement." Weng Qihui said that although the blinding data did not reach statistical significance, but the vaccine perspective, the results are good; Zhang Nianci also said "unexpected success", but analysts said that the blinding result may be "scientific Success, regulatory failure."
After the release of the new drug on Wednesday, Hao Ding announced that the stock price fluctuated fiercely in the last two trading days before the blinding. Yesterday, Hao Ding held a press conference at the counter buying center, and the investors of Xinjiao were crowded outside. Hao Ding's share price is bound to face a severe test. Hao Ding announced last night that it will hold a law conference after the closing of Taiwan stocks to strengthen communication with the market.
Zhang Nianci said that due to the data "positive", the global clinical phase III trial will be launched, and the pre-clinical trial communication with the US, European and Canadian regulatory agencies will be conducted immediately. A consultation meeting with the Taiwan Food and Drug Administration will also be held to discuss whether the drug can be applied. Evidence or re-planning the clinical phase III trial. Xu Yougong, the vice chairman of Hao Ding, said that the clinical design was in 2009. At that time, the market did not understand the characteristics of immunotherapy. Now, it seems that the series of sugar molecules selected by the new anti-milk cancer drug OBI-822 is correct.
Hao Ding stressed that the clinical data clearly shows that the vast majority of subjects have an immune response, and those with immune response have more efficacy, in other words, this is a safe and effective vaccine. Huang Xingmei, general manager of Haoding, said that this product has confirmed that it has a very clear message for cancer prevention. The next clinical design does not need to distinguish the type of breast cancer patients. It is only necessary to distinguish whether antibodies are produced, in other words, the next experimental design. Only success, no failure."
Blindness
Before the new drug is marketed, human clinical trials must be carried out. The clinical trial is to determine the safety and efficacy of the drug. In the second and third phase of the clinical trial, in order to confirm the efficacy, the "double-blind" mode is usually used for testing. The blinding is to expose the test. result. Double-blind refers to the “control group and experimental group†in which the patients were randomly assigned to the drug. The experimental group was given the test drug, while the control group was given the placebo. Since the subject or the person conducting the test does not know the actual distribution result, it is called double-blind; until the end of the trial, the collection and statistics are started and the final result is confirmed. Pay attention to Anhui Dafu.com WeChat public number (ID: ahdoctor34), for more information.
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