subject: Clinical Trials, Phase 0 Is Expected To Accelerate New Drug - Drug, Clinical Trial - Pharmaceutical [print this page] Recent meeting of the American from Chicago Clinical Cancer Society annual meeting that the United States National Cancer Institute researchers have successfully completed the drug ABT-888 clinical trial of 0. ABT-888 is Abbott Pharmacy Developed for the treatment of a variety of advanced cancer patients, the role of theory is off, called " PA RP "protein, this protein may prevent some cancer cells resist the body Immunity Function. 0 clinical trial was to change the traditional development process, will greatly reduce the drugs enter clinical time.
New drug development experience difficulties 0 clinical trials came into being
New drugs are often Investment Large, long time-consuming, risky. A new drug from the initial screening of chemicals to the final market, generally require 800 million ~ 900 million U.S. dollars of investment, time-consuming 10 to 12 years. And high risk of drug research, in general, screening out of 50 compounds there is only one access to clinical research, while four entered phase clinical trial of new drugs in the end, only one can get FDA approval to market the U.S. . Powerful pharmaceutical companies have enough money to take multiple drugs at the same time research project, but for those small, or just entered the pharmaceutical industry, new companies, new drug development risks are too great. In addition, the supervision of drug development Management Also become more stringent, this makes the number of annual new drug FDA approved the trend was gradually shrinking.
Therefore, new drug research and development to reduce the risk of the process, so that more new drugs to market as quickly as possible, in January this year, FDA proposed the concept of clinical trials 0. Using micro-doses of drugs first tested in a small number of populations, can the developer of new drugs entering clinical trials to the high official of the former, a small amount of money spent to collect valuable new drug in the human body Security And pharmacokinetics of data to guide further clinical research. If clinical trials of new drugs in the 0 appears in security issues, the developer of new drug can be given up in clinical trials in a timely manner to avoid unnecessary large capital investment; the other hand, have first-hand the safety of new drugs in humans resistance and pharmacokinetics data, the developer of new drugs can be developed based on these data, a more formal clinical trials, scientific program, making the latter part of the smooth conduct of clinical trials of new drugs.
ABT-888 Test It uses a new type of 0 means the clinical trial. Aim is to find biomarkers in vivo in patients with medication changes, and not to determine the safety of drugs and specific effects in order to obtain relevant data faster, speed up the development process.
ABT-888 shut down the target protein activities and repair damaged DNA. In the absence of an active enzyme, tumor cells of several cancer drugs will be more sensitive. The key personnel involved in the study, Dr. JamesH.Doroshow revealed a unique aspect of this research is to develop a rigorous testing methods to measure the ABT-888 is good or bad. The results show that the drug inhibited in tumor cells and Cycle White blood cells in the targeted protein. Later research showed that leukemia cells can be applied to the test, the test can easily detect whether the altered protein. Early in the study, his research is a proof of principle, to determine whether this new method is feasible. But this study also need to do a lot of the U.S. National Cancer Institute's laboratory and clinical basic research.
0 value of clinical trial geometry
Still need to confirm
JohnE.Niederhuber National Cancer Institute Director Dr., this test method is a new development tool that will comprehensively promote the capture of cancer and drug research. However, ABT-888 studies were needed with the United States Food Drug Administration to maintain close consultation and collaboration in order to ensure that research carried out smoothly. Dr. Niederhuber said that the tests from design to actual research data collected no more than 6 months.
