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Myrcludex B development
Does somebody know the progress of Myrcludex B development? There are materials mentioning that this drug can potentially eradicate HBV.
it depends on the drug makers and market mainly but when the drugs allows to make a lot of money they are superfast entecavir took about 5 years even if they found cancer on rodents but not on primates
so i'd say about 5 years if they want it
you shouldn t worry about tenofovir resistance if you have reached hbvdna und you don t get resistance easily plus there re combos to prevent that:
entecavir+tenofovir or tenofovir+ftc or addition of nitazoxanide if you have lam or adv resistance
Phases of Clinical Trials
Drug research involves many stages. Much of the knowledge about drugs is derived from initial laboratory research in animals. Animals are used during the drug development phase, primarily to confirm lack of toxicity. Laboratory primate animals are protected by a separate set of regulations governing the care and use of animals. If it looks like a drug has potential therapeutic value without major toxicity in laboratory tests, it is then time to advance to the next stage. The researchers must submit an application to the FDA; this application process is very extensive. If the FDA grants permission to proceed after careful review of the preliminary data, then drug testing – clinical trials – can begin on humans.
Clinical trials can be divided into four phases. The process begins with a Phase I trial – the initial introduction of an investigational new drug into humans. These tests may be conducted in patients, but are usually conducted in healthy volunteers (usually 20 to 80 subjects). The goals of a Phase I trial are to evaluate safety and tolerability (i.e., lack of major side effects) as well as the dosage range. This is determined by testing a range of doses (called a dose-ranging trial). Study participants initially receive a low dose of the drug; this is gradually increased as long as the drug appears to be safe. Phase I studies may provide early indications of the drug’s effectiveness, but whether or not a drug works is the primary focus of later Phase II and Phase III studies.
In Phase II trials, early controlled clinical studies are conducted to obtain preliminary data on the effectiveness (also known as efficacy) of the drug for the particular indication, such as treatment of chronic hepatitis C. This phase also allows further collection of data on the common short-term side effects and risks associated with the drug. Phase II studies are conducted in a relatively small number of patients, usually involving several hundred people.
After preliminary evidence of effectiveness is confirmed in phase II studies, expanded controlled and uncontrolled phase III studies are conducted to gain additional information on effectiveness and safety. In this phase, the study drug is given to several hundred to several thousand of patients. In Phase III studies, the new drug may be compared to current standard therapy.
Phase IV trials are post-marketing studies conducted after the drug has been approved and marketed, often to further confirm safety. These studies are done in order to gain more specific information about the drug, such as how the drug interacts with other drugs or how it works in people with other diseases. Phase IV trials may include large numbers of patients (some Phase IV trials are small), and may reveal uncommon side effects that are too rare to show up in Phase II or III studies.
Laboratory testing is performed regularly while an experimental drug is being tested in humans, thus new information about the drug’s safety and effectiveness comes from blood tests as well as patient interviews and physical examinations.
Before a drug is approved for marketing, it is called an investigational new drug (IND). The total time it takes to bring a drug to market can vary. The preclinical laboratory phase averages about five years, and the length of time an investigational drug is in clinical trials averages seven years. According to an article published by the FDA in 1999, only one in 1,000 compounds make it from the laboratory to human testing, and only one in five of these receive FDA approval for marketing (www.fda.gov).
Drug research involves many stages. Much of the knowledge about drugs is derived from initial laboratory research in animals. Animals are used during the drug development phase, primarily to confirm lack of toxicity. Laboratory primate animals are protected by a separate set of regulations governing the care and use of animals. If it looks like a drug has potential therapeutic value without major toxicity in laboratory tests, it is then time to advance to the next stage. The researchers must submit an application to the FDA; this application process is very extensive. If the FDA grants permission to proceed after careful review of the preliminary data, then drug testing – clinical trials – can begin on humans.
Clinical trials can be divided into four phases. The process begins with a Phase I trial – the initial introduction of an investigational new drug into humans. These tests may be conducted in patients, but are usually conducted in healthy volunteers (usually 20 to 80 subjects). The goals of a Phase I trial are to evaluate safety and tolerability (i.e., lack of major side effects) as well as the dosage range. This is determined by testing a range of doses (called a dose-ranging trial). Study participants initially receive a low dose of the drug; this is gradually increased as long as the drug appears to be safe. Phase I studies may provide early indications of the drug’s effectiveness, but whether or not a drug works is the primary focus of later Phase II and Phase III studies.
In Phase II trials, early controlled clinical studies are conducted to obtain preliminary data on the effectiveness (also known as efficacy) of the drug for the particular indication, such as treatment of chronic hepatitis C. This phase also allows further collection of data on the common short-term side effects and risks associated with the drug. Phase II studies are conducted in a relatively small number of patients, usually involving several hundred people.
After preliminary evidence of effectiveness is confirmed in phase II studies, expanded controlled and uncontrolled phase III studies are conducted to gain additional information on effectiveness and safety. In this phase, the study drug is given to several hundred to several thousand of patients. In Phase III studies, the new drug may be compared to current standard therapy.
Phase IV trials are post-marketing studies conducted after the drug has been approved and marketed, often to further confirm safety. These studies are done in order to gain more specific information about the drug, such as how the drug interacts with other drugs or how it works in people with other diseases. Phase IV trials may include large numbers of patients (some Phase IV trials are small), and may reveal uncommon side effects that are too rare to show up in Phase II or III studies.
Laboratory testing is performed regularly while an experimental drug is being tested in humans, thus new information about the drug’s safety and effectiveness comes from blood tests as well as patient interviews and physical examinations.
Before a drug is approved for marketing, it is called an investigational new drug (IND). The total time it takes to bring a drug to market can vary. The preclinical laboratory phase averages about five years, and the length of time an investigational drug is in clinical trials averages seven years. According to an article published by the FDA in 1999, only one in 1,000 compounds make it from the laboratory to human testing, and only one in five of these receive FDA approval for marketing (www.fda.gov).
no to prevent resistance for life treatment, once resistance to tnf happens it is too late but until now 3-4 years no mutations have been detected even in those with hbvdna detactable
so resistance will be difficult on tnf and will require many years
the most used combos are tnf+ftc (embricitabine) and tnf+etv, results of a trial tnf+etv on naive patients started on 2007 will be presented at the liver meeting in boston on october/november, this trial will be finished in 2012
we are lucky it is germany the country for the trials, i don t trust USA FDA at all...
in italy they have currently connected research and human testing immediately for cancer drugs......we are in 2010 and all those years can be avoided most of the time, the toxicity testing is not exactly a matter of time
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