标题: Mycrludex: some discussions from Medhelp [打印本页] 作者: StephenW 时间: 2012-4-8 10:47 标题: Mycrludex: some discussions from Medhelp
本帖最后由 StephenW 于 2012-4-8 10:54 编辑
Oksana Markova, the director of Hepatera Company ( "Markova Oksana" ), reported that second phase of Myrcludex B clinical trials will begin in august - september of this year in several Russian cities.
ytdthjznyj Apr 04, 2012
At the moment they select the group with Hbe-, but don't tell the name of drug (we think that drug is Myrcludex). The treatment will last 3 month as a subcutaneous injection. The control group will be entecavir - three month. ytdthjznyj Apr 04, 2012
3 month as a subcutaneous injection every day stef2011 Apr 04, 2012 To: ytdthjznyj
wow so they have little data it may lower hbvdna in just 3 months, i thought it was slow activity
very very good, it looks like russians dont waste time like US trials, if they also publish results fast on internet and get it on market in russia in a very short time this may change hbv treatment for next years
ytdthjznyj Apr 04, 2012
From autumn will be several groups, perhaps, with different methods of treatment. I will inform when there will be any news. 4est Apr 04, 2012 To: ytdthjznyj
do you have some link's to this discussion / announcement / clinical trials ? ytdthjznyj Apr 04, 2012
No, I didn't look for. My info is from the e-mail answer of Oksana Markova and from Moscow clinic, which is now recruiting for clinical trial stef2011
Apr 04, 2012
To: ytdthjznyj
please ask when they will have drug available on people already on longterm nucs or nucs+peginterferon, this will be the final therapy i guess studyforhope 9 hours To: chrisso
Infected cells die in the liver every day and are replenished with de novo infected cells from reinfection or division of infected cells. This is normally in equilibirum, hence no change in cccDNA and surface antigen levels. Myrcludex can block the reinfection, thus under the assumption of a high rate of infected cell elimination the infected pool will start to shrink.
The daily rate of hepatocyte destruction ( or noncytolytic clearance, as an alternative mechanism) will vary strongly from patient to patient. So will the effectiveness of Myrcludex on the speed of pool reduction, for that reason.
The relative poolsize during treatment can be estimated by VL measurements and quant HbSAg determinations. In 3 month they might see a development towards clear reduction in some patients that have a more rapid intrahepatic turnover of infected cells and a total percentage of infected cells that is rather low, since only then Myrcludex can work, since it cannot prevent viral spreading by infected cell division.
Treatment should be monitored and continued until negativity if the initial 3 month show a signal of reduction in a patient. The majority of chronic HBV patients are unlikely to clear within 3 month. Nevertheless the results of such a trial might give enough information to design the next trial towards a more lasting endpoint. 作者: StephenW 时间: 2012-4-8 10:59
Entry Inhibition: Stopping HBV and HDV at the Cell Door An interesting strategy called entry inhibition, which is being used successfully against HIV and flu infections, may hold promise in preventing hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. Dr. Stephan Urban of Heidelberg University, Germany, and Dr. Philippe Gripon of the University of Rennes, France, have discovered a unique protein fragment (called a peptide) that could be used against HBV and HDV. Dr. Urban’s team is developing the peptide into a drug known as an entry inhibitor. The drug blocks a key process that the virus needs to enter specialized liver cells called hepatocytes. This is a different mechanism than that of standard antiviral drugs, which stop the virus from replicating once it is inside hepatocytes. If it is shown to work, the entry inhibitor would be a major breakthrough, especially with HDV, because there are currently no treatments for HDV. Who could benefit from this drug?
The entry inhibitor may be effective in people with chronic (long-term) HBV infections and in people who have both HBV and HDV infections. The drug may also prevent reinfections in people who have had a liver transplant or those being treated with standard antiviral therapy. Another exciting application of the entry inhibitor is its possible use in preventing HBV transmission from infected pregnant women to their babies. The entry inhibitor may protect the unborn baby’s hepatocytes from becoming infected. Alternatively the baby could be treated with the drug immediately after birth and additionally receive the HBV vaccination for further, long-term protection. How will it be given?
Because it stays effective for more than 2 days, the drug probably will be given daily or every 2 to 3 days as a single-dose injection under the skin. Dr. Urban’s team is studying whether the drug can be given on a long-term basis (e.g., a 6-month period) and plans to develop a slow-release form, which means the drug could be given less frequently. Can it be used with other antiviral drugs?
Yes. Standard antiviral agents stop the virus from replicating inside infected cells, while the entry inhibitor stops the virus from infecting new cells. If the two types of drugs are used in combination, they may work together to increase the chances of clearing the virus and possibly offering a cure for HBV. What about resistance?
Sometimes viruses undergo genetic alterations that make them resistant to a drug. This means the drug no longer works against the virus. Drug resistance is a constant problem with many standard antiviral agents, but Dr. Urban believes resistance is less likely with his team’s entry inhibitor. This is because the entry inhibitor mimics a protein fragment that the virus must have to be able to infect hepatocytes. So it is unlikely that the virus will undergo an alteration in this fragment. Is the drug safe?
The researchers have found no toxic effects of the drug after testing very high daily doses for 6 months in rats and 3 months in dogs. Dr. Urban’s team and the Heidelberg Clinical Trial Unit, headed by Dr. Emil Haefeli, are studying the drug in healthy human volunteers to find out if the drug is safe at the most effective dosing levels. A phase II trial, expected to start by early 2013, will study how well the drug works in people chronically infected with HBV and people with both HBV and HDV infections. The researchers will also study how well the entry inhibitor works in combination with interferon.
The preclinical trials were supported by the German Federal Ministry of Education and Research. The phase I clinical trials are supported by a grant from the German National Center for Tumor Diseases (NCT), Heidelberg. The company Myr-GmbH holds the exclusive license on the patents and is sponsoring the clinical trials.
The Hepatitis B Foundation has added this entry inhibitor to its Drug Watch and will continue to follow the development of this promising strategy.
Oksana Markova, the director of Hepatera Company ( "Markova Oksana" ), reported that second phase of Myrcludex B clinical trials will begin in august - september of this year in several Russian cities.
A phase II trial, expected to start by early 2013, will study how well the drug works in people chronically infected with HBV and people with both HBV and HDV infections.
"A phase II trial, expected to start by early 2013, will study how well the drug works in people chronically infected with HBV and people with both HBV and HDV infections. " -
这个声明已经被取代.作者: StephenW 时间: 2012-4-13 19:31