Aa
AASLD 2012: Myrcludex
CONTROL ID: 1421750
PRESENTATION TYPE: Oral or Poster
CURRENT CATEGORY: Hepatitis B
CURRENT DESCRIPTORS: I02. Treatment and Clinical Trials
TITLE: Successful first administration of Myrcludex B, a first-in-class Hepatitis B and D Virus entry inhibitor, in humans
AUTHORS (FIRST NAME, LAST NAME): Walter E. Haefeli1, Antje Blank1, Gerd Mikus1, Walter Mier2, Alexander Alexandrov3, Stephan Urban4
Institutional Author(s):
INSTITUTIONS (ALL): 1. Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, Germany.
2. Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany.
3. Myr-GmbH, Burgwedel, Germany.
4. Department of Infectious Diseases, Molecular Virology, University Hospital Heidelberg, Heidelberg, Germany.
ABSTRACT BODY: Background and aims: Current antiviral therapies for chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) infections are limited and mostly non-curative. This requires the development of novel strategies interfering with hitherto unaddressed steps of virus replication. Myrcludex B an HBV envelope-protein derived lipopeptide specifically inactivates an essential HBV/HDV-receptor on differentiated hepatocytes. Myrcludex B is highly effective against HBV and HDV in animal models, has successfully passed preclinical studies and represents the first-in-class entry inhibitor for HBV/HDV infection. We have conducted a prospective, open-label, non-randomized, non-controlled Phase 0/1 clinical study to evaluate safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of Myrcludex B in healthy volunteers.
Methods: Single doses of Myrcludex B (0.3, 3, 10, 100, 800, 3000, and 5000 µg) were administered IV or SC (800 µg) to cohorts of 3 participants, followed up for 28 days. Dose escalation to the subsequent higher dose was performed after positive safety evaluation of comprehensive clinical and laboratory data by an independent Data Safety Monitoring Board. Plasma concentrations were determined by HPLC-MS from repeated samples collected up to 72h after dosing and PK parameters were calculated using a two-compartment model. Immunogenicity was studied by RIA.
Results: 24 participants were exposed and 53 adverse events were recorded (none was serious). All events were transient, recovered without sequelae, did not show a pathophysiological relation to the study drug’s mode of action, and appeared dose-independent. No signs of liver involvement were detected. PK in humans was linear up to the dose of 3 mg. At dose exposures of 5 mg, markedly increased plasma concentrations and decreased clearance were observed possibly indicating saturation of the central compartment (liver). This result was consistent with in vivo studies in different species, including chimpanzee. No anti-drug antibodies (ADA) were detected.
Conclusion: Myrcludex B was very well tolerated in healthy volunteers for all investigated doses for up to 5 mg IV and 0.8 mg SC. The PK profile is in line with the expectations based on animal studies. Continuation to multiple dose human studies is encouraged by these results.
(No Table Selected)
(No Image Selected)
Co-Author Disclosure Status
The following authors have completed their AASLD 2012 disclosure:
Walter Haefeli: Disclosure completed
Antje Blank: Disclosure completed
Gerd Mikus: Disclosure completed
Walter Mier: Disclosure completed
Alexander Alexandrov: No Answer.
Stephan Urban: Disclosure completed
PRESENTATION TYPE: Oral or Poster
CURRENT CATEGORY: Hepatitis B
CURRENT DESCRIPTORS: I02. Treatment and Clinical Trials
TITLE: Successful first administration of Myrcludex B, a first-in-class Hepatitis B and D Virus entry inhibitor, in humans
AUTHORS (FIRST NAME, LAST NAME): Walter E. Haefeli1, Antje Blank1, Gerd Mikus1, Walter Mier2, Alexander Alexandrov3, Stephan Urban4
Institutional Author(s):
INSTITUTIONS (ALL): 1. Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, Germany.
2. Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany.
3. Myr-GmbH, Burgwedel, Germany.
4. Department of Infectious Diseases, Molecular Virology, University Hospital Heidelberg, Heidelberg, Germany.
ABSTRACT BODY: Background and aims: Current antiviral therapies for chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) infections are limited and mostly non-curative. This requires the development of novel strategies interfering with hitherto unaddressed steps of virus replication. Myrcludex B an HBV envelope-protein derived lipopeptide specifically inactivates an essential HBV/HDV-receptor on differentiated hepatocytes. Myrcludex B is highly effective against HBV and HDV in animal models, has successfully passed preclinical studies and represents the first-in-class entry inhibitor for HBV/HDV infection. We have conducted a prospective, open-label, non-randomized, non-controlled Phase 0/1 clinical study to evaluate safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of Myrcludex B in healthy volunteers.
Methods: Single doses of Myrcludex B (0.3, 3, 10, 100, 800, 3000, and 5000 µg) were administered IV or SC (800 µg) to cohorts of 3 participants, followed up for 28 days. Dose escalation to the subsequent higher dose was performed after positive safety evaluation of comprehensive clinical and laboratory data by an independent Data Safety Monitoring Board. Plasma concentrations were determined by HPLC-MS from repeated samples collected up to 72h after dosing and PK parameters were calculated using a two-compartment model. Immunogenicity was studied by RIA.
Results: 24 participants were exposed and 53 adverse events were recorded (none was serious). All events were transient, recovered without sequelae, did not show a pathophysiological relation to the study drug’s mode of action, and appeared dose-independent. No signs of liver involvement were detected. PK in humans was linear up to the dose of 3 mg. At dose exposures of 5 mg, markedly increased plasma concentrations and decreased clearance were observed possibly indicating saturation of the central compartment (liver). This result was consistent with in vivo studies in different species, including chimpanzee. No anti-drug antibodies (ADA) were detected.
Conclusion: Myrcludex B was very well tolerated in healthy volunteers for all investigated doses for up to 5 mg IV and 0.8 mg SC. The PK profile is in line with the expectations based on animal studies. Continuation to multiple dose human studies is encouraged by these results.
(No Table Selected)
(No Image Selected)
Co-Author Disclosure Status
The following authors have completed their AASLD 2012 disclosure:
Walter Haefeli: Disclosure completed
Antje Blank: Disclosure completed
Gerd Mikus: Disclosure completed
Walter Mier: Disclosure completed
Alexander Alexandrov: No Answer.
Stephan Urban: Disclosure completed
I was speaking of a bigger issue then just in the US. And believe me people here are speaking out that is why the laws are changing for the better towards the little guy.
"It is illegal to raise any public money for a company without a prospectus in Canada" - Еxаctly! :) Illegal to save lifes! But is it moral?
All I am saying is that we are all in this together. Didn't one of you say that Replicor has no money to go on with the development of the drug and they are looking for a buyer - big investor? Why can't it be us - there is 300 million of us hbv sickos?
I simply said then here you go, lets come up with the strategy, and address this issue. And have a dialog with the company directly.
You actually have to picture this situation like this. If a company A goes public saying we have a CURE for HepB.. but we have no funds to take it further and the laws in our country prohibit us to collect funds online for this good cause. Please help us for the sake of those that are sick!
Don't you think the media and public opinion will have something to say about it when shown how much liver cancer is caused by HBV in young people and how many die from it? And how much a patient like that is a burden on the health care system financially - tax payers then there is a solution.
These kinds of big corporate lobbied laws are an easy BUST if the people speak out. Remember there is 99% of us and only 1% of them. But this 1% world wide is active, and in charge of all the resources, and lobbies laws their ways secretively within their own circle to first protect their interest. But they are worried of the public opinion because 99% is in another camp..
The times are changing - the 21st century will be the end of monopolies. People world wide are now speaking out in favor of a more just society. There is a tremendous understanding of the root causes of the problems we are faced with today.
So we as HBV crowd have to do our own part to get these better treatments become available faster. We have to look and fight for our own interests. Because based on what was said here Replicor has a funding issues to move along faster. They are a small company it is understandable it is hard to play on the same field with Gilead and BM.
You have to understand this also. That a company cannot hold a patent on a cure of this significance. HepB is an international humanitarian crisis. Of which the public is not really aware. Most people have never heard of HBV or those that do think there is a vaccine against it. They are not aware of the 300 million sick people. And withholding the release of a cure like this can be looked at the same way as somebody has just put a patent on water or air we breathe. That is why such small clinical trials are being conducted over the course of many years. Because these companies are all players on one market field and the doctors lobby too - nobody wants to upset or pull ahead of the other guy taking out the niche market being Jesus Christ when everybody are eating from the same plate based on this structure that is in place. That is a one and a quick way to become outsider in that club especially for the CEO that may want to move on to another company using his network associations. To them our illness is an industry and it is operated like that.
At the same time yes, people that worked on the research need to be reworded financially. But why does it have to do with making private investors richer or depend on their say on when is is a better time to release the drug when this is a humanitarian crisis issue? You are OK with this?
It is illegal to raise public funds to cure people from one of the 3 known worst viruses to date.
"It is illegal to raise any public money for a company without a prospectus in Canada" - Еxаctly! :) Illegal to save lifes! But is it moral?
All I am saying is that we are all in this together. Didn't one of you say that Replicor has no money to go on with the development of the drug and they are looking for a buyer - big investor? Why can't it be us - there is 300 million of us hbv sickos?
I simply said then here you go, lets come up with the strategy, and address this issue. And have a dialog with the company directly.
You actually have to picture this situation like this. If a company A goes public saying we have a CURE for HepB.. but we have no funds to take it further and the laws in our country prohibit us to collect funds online for this good cause. Please help us for the sake of those that are sick!
Don't you think the media and public opinion will have something to say about it when shown how much liver cancer is caused by HBV in young people and how many die from it? And how much a patient like that is a burden on the health care system financially - tax payers then there is a solution.
These kinds of big corporate lobbied laws are an easy BUST if the people speak out. Remember there is 99% of us and only 1% of them. But this 1% world wide is active, and in charge of all the resources, and lobbies laws their ways secretively within their own circle to first protect their interest. But they are worried of the public opinion because 99% is in another camp..
The times are changing - the 21st century will be the end of monopolies. People world wide are now speaking out in favor of a more just society. There is a tremendous understanding of the root causes of the problems we are faced with today.
So we as HBV crowd have to do our own part to get these better treatments become available faster. We have to look and fight for our own interests. Because based on what was said here Replicor has a funding issues to move along faster. They are a small company it is understandable it is hard to play on the same field with Gilead and BM.
You have to understand this also. That a company cannot hold a patent on a cure of this significance. HepB is an international humanitarian crisis. Of which the public is not really aware. Most people have never heard of HBV or those that do think there is a vaccine against it. They are not aware of the 300 million sick people. And withholding the release of a cure like this can be looked at the same way as somebody has just put a patent on water or air we breathe. That is why such small clinical trials are being conducted over the course of many years. Because these companies are all players on one market field and the doctors lobby too - nobody wants to upset or pull ahead of the other guy taking out the niche market being Jesus Christ when everybody are eating from the same plate based on this structure that is in place. That is a one and a quick way to become outsider in that club especially for the CEO that may want to move on to another company using his network associations. To them our illness is an industry and it is operated like that.
At the same time yes, people that worked on the research need to be reworded financially. But why does it have to do with making private investors richer or depend on their say on when is is a better time to release the drug when this is a humanitarian crisis issue? You are OK with this?
It is illegal to raise public funds to cure people from one of the 3 known worst viruses to date.
It is illegal to raise any public money for a company without a prospectus in Canada. If you feel so strongly about raising money online for Replicor, go ahead, just don't rave on here. Hot air is not money. Not all of us live in America, being a democracy, you choose your governments that regulate your pharma. Rant to your own American citizens, we are not interested
If you are OK with the fact that big pharma is blocking the release of cures for HBV till they can make enough money from antivirals then I feel sorry for you if 2+2 = whatever they tell you.
There are clearly better medicines available that can be used today that are not being used. The research is slow and is focused mainly around the antiviral agents that they give us that were intended to treat HIV. If it does not have any effect on the surface antigen then why take it?
And... the majority of the research is sponsored by these same big pharma drug companies thus those that do research are dependent on the one who is sponsoring the research.
So speaking against it you call it "obsessive and excessive" And ya still wonder why there is no change? And why the world in such a mess today. These large companies and special interests groups fight for every inch of what us good for them and set up laws that allow them to do what they do legally and quite often against all morals.
You yourself said it is illegal to even raise money online for Replicor to save peoples lifes! And you are OK with that? Don't you want to have a normal life in 3 months rather then taking Tenofovir life time that will damage your kidneys along the way?
Because of go with the flow folks like yourself that wait for solutions from somebody else and that cannot or don't want to organize to protect their own rights and interests and speak out we still don't have a cure for HepB released when it is in fact there. And we are dependent on when the drug company decides we can have the drug.
Everything unfortunately is political especially these days, and slanted usually one way to profit and heavily on somebody's misfortune. That is why there are such huge profits billions in just the pharmaceutical business. And I am sorry you don't realize it or can't connect the dots. Because there lies the problems. And in order to come up with a better solution you first need to discuss the problem and wake people up who are in the dark. That is what it means to be a human being to have morals first and most. If there is a cure it has to be released there is no moral law that says it is otherwise.
and btw... it was not me that started to digress off topic I simply corrected DJ on his "facts"
There are clearly better medicines available that can be used today that are not being used. The research is slow and is focused mainly around the antiviral agents that they give us that were intended to treat HIV. If it does not have any effect on the surface antigen then why take it?
And... the majority of the research is sponsored by these same big pharma drug companies thus those that do research are dependent on the one who is sponsoring the research.
So speaking against it you call it "obsessive and excessive" And ya still wonder why there is no change? And why the world in such a mess today. These large companies and special interests groups fight for every inch of what us good for them and set up laws that allow them to do what they do legally and quite often against all morals.
You yourself said it is illegal to even raise money online for Replicor to save peoples lifes! And you are OK with that? Don't you want to have a normal life in 3 months rather then taking Tenofovir life time that will damage your kidneys along the way?
Because of go with the flow folks like yourself that wait for solutions from somebody else and that cannot or don't want to organize to protect their own rights and interests and speak out we still don't have a cure for HepB released when it is in fact there. And we are dependent on when the drug company decides we can have the drug.
Everything unfortunately is political especially these days, and slanted usually one way to profit and heavily on somebody's misfortune. That is why there are such huge profits billions in just the pharmaceutical business. And I am sorry you don't realize it or can't connect the dots. Because there lies the problems. And in order to come up with a better solution you first need to discuss the problem and wake people up who are in the dark. That is what it means to be a human being to have morals first and most. If there is a cure it has to be released there is no moral law that says it is otherwise.
and btw... it was not me that started to digress off topic I simply corrected DJ on his "facts"
"whose interest do you represent here?"
This is a question you should ask yourself. Speaking for myself, I represent my own interest in learning and sharing medical and scientific information about HBV. To rant about big pharma and the health care system in your own country is your right, but to color every discussion with your personal political opinions is obsessive and excessive.
Start your own topic of discussion if you must, but spare the rest of us.
This is a question you should ask yourself. Speaking for myself, I represent my own interest in learning and sharing medical and scientific information about HBV. To rant about big pharma and the health care system in your own country is your right, but to color every discussion with your personal political opinions is obsessive and excessive.
Start your own topic of discussion if you must, but spare the rest of us.
health care is free just about in any civilized society btw. That is one of the criteria by which a country is judged - its healh care system. And that is another fact for you.
Why do you only mention North Korea?:) France; Italy; Germany the UK and Canada all have it. AND guess what fibroscan and hep b surface antigen quant is there available too and without hassle.
ps. You still did not anwer whos interst you represent here ;)
Why do you only mention North Korea?:) France; Italy; Germany the UK and Canada all have it. AND guess what fibroscan and hep b surface antigen quant is there available too and without hassle.
ps. You still did not anwer whos interst you represent here ;)
Like they always say, "if you don't like it here, then go somewhere else". No one is forcing you to stay here and live under this "oppressive" regime. Maybe you'd be better off in North Korea where medical care is free?
And maybe the reason Scantibodies didn't want to cooperate with you is because of the negativity? I was able to get what I needed from them (HBsAg Quant) and move on with nothing but a small prick in my arm.
And maybe the reason Scantibodies didn't want to cooperate with you is because of the negativity? I was able to get what I needed from them (HBsAg Quant) and move on with nothing but a small prick in my arm.
ps. here how "wonderful" things are...
http://www.pcip.ca.gov/PCIP_Program/FAQs.aspx
"I am currently enrolled in MRMIP. The program has an annual benefit cap of $75,000 per calendar year and a $750,000 lifetime cap. Do I qualify for PCIP, when I reach the MRMIP benefit or lifetime cap limit?
No, the PCIP requires that an individual be without health insurance for at least 6 months. To qualify for PCIP, you cannot have health coverage 6 months prior to applying. Because you are currently enrolled in the MRMIP, you do not qualify for PCIP"
Which begs me to ask a question to a politician that thinks this is normal.
Say an HBV guy needs a liver transplant which exceeds $75,000 USD annually and he cannot stop one insurance coverage - wait months then apply for a new plan. Then What is he supposed to do?
I say this is another example of how corrupt things are here. That insurance companies were able to lobby this till 2014.
http://www.pcip.ca.gov/PCIP_Program/FAQs.aspx
"I am currently enrolled in MRMIP. The program has an annual benefit cap of $75,000 per calendar year and a $750,000 lifetime cap. Do I qualify for PCIP, when I reach the MRMIP benefit or lifetime cap limit?
No, the PCIP requires that an individual be without health insurance for at least 6 months. To qualify for PCIP, you cannot have health coverage 6 months prior to applying. Because you are currently enrolled in the MRMIP, you do not qualify for PCIP"
Which begs me to ask a question to a politician that thinks this is normal.
Say an HBV guy needs a liver transplant which exceeds $75,000 USD annually and he cannot stop one insurance coverage - wait months then apply for a new plan. Then What is he supposed to do?
I say this is another example of how corrupt things are here. That insurance companies were able to lobby this till 2014.
I pay $700 a month and have proof :)
I wish you were a bit more up front who's interest you represent here. :)
And what other company offers hep b surface antigen quant test? I am sure many here would like to know. Because we are in the dark without these results.
Look I even offered Scantibodies money for the test to monitor my numbers.
Anyway the bottom line is if you know something please share with people.
As for debating how wonderful the US health care system is I want just watch this film http://en.m.wikipedia.org/wiki/Sicko
Things are of course are getting better but they are a long ways away from what is acceptable.
I wish you were a bit more up front who's interest you represent here. :)
And what other company offers hep b surface antigen quant test? I am sure many here would like to know. Because we are in the dark without these results.
Look I even offered Scantibodies money for the test to monitor my numbers.
Anyway the bottom line is if you know something please share with people.
As for debating how wonderful the US health care system is I want just watch this film http://en.m.wikipedia.org/wiki/Sicko
Things are of course are getting better but they are a long ways away from what is acceptable.
well speaking for myself, HBsAg was done with and they drew 3 very small vials of blood, no plasmapherisis was done. I was the one that notified this group that Scantibodies was doing this test. There is another company doing this test and they will COME TO YOU for the blood draw. However, they cannot give you the quant number, only a level (low, med, high, etc.).
My PCIP coverage is less than $250 per month, a bargain.
My PCIP coverage is less than $250 per month, a bargain.
Ok. FACTS.
To be illegible for PCIP you need to be six months without insurance. IF you have had some type of coverage you are no eligable. So not everybody is eligible for PCIP. Everything is in the fine print.
As for treatment caps google it yourself. And as I said health insurance companies can still deny health insurance to people with HepB. Till 2014 when the law will prohibit them to do so. Dont believe me? Fill out a private health insurance application form on line and report the results so you can get a better monthly rate then with PCIP plan which is like $500 a monthly.
2. SCANTIBODIES in San Diego specifically want plasma donations in exchange for this test only. And yes I think they pay like $50 for a large some.
If I am wrong with my facts and they have changed their policy have them come here and say it ain't so or please provide to a link in writing where they say they can give the test for just one tube of blood since we are talking about facts :)
As far as which procedure is better and safer Fibroscan vs Biopsy maybe stef2011 can come here and give his points.
To be illegible for PCIP you need to be six months without insurance. IF you have had some type of coverage you are no eligable. So not everybody is eligible for PCIP. Everything is in the fine print.
As for treatment caps google it yourself. And as I said health insurance companies can still deny health insurance to people with HepB. Till 2014 when the law will prohibit them to do so. Dont believe me? Fill out a private health insurance application form on line and report the results so you can get a better monthly rate then with PCIP plan which is like $500 a monthly.
2. SCANTIBODIES in San Diego specifically want plasma donations in exchange for this test only. And yes I think they pay like $50 for a large some.
If I am wrong with my facts and they have changed their policy have them come here and say it ain't so or please provide to a link in writing where they say they can give the test for just one tube of blood since we are talking about facts :)
As far as which procedure is better and safer Fibroscan vs Biopsy maybe stef2011 can come here and give his points.
Fibroscan, while it may be good for early or late fibrosis, is not so good for middle of the road fibrosis. There are other tests available today that can show the density of the liver.
I was able to get my HBsAg for one blood draw and one vial worth of blood. No plasmaphoresis needed. Plus, they PAID me for this!
I got health insurance last year through the state's PCIP program with no treatment/spending cap. I have used it to pay for all of my meds and all of my doctor's bills. This is in effect NOW, not in 2014.
Please get all of your facts straight before spreading disinformation.
I was able to get my HBsAg for one blood draw and one vial worth of blood. No plasmaphoresis needed. Plus, they PAID me for this!
I got health insurance last year through the state's PCIP program with no treatment/spending cap. I have used it to pay for all of my meds and all of my doctor's bills. This is in effect NOW, not in 2014.
Please get all of your facts straight before spreading disinformation.
According to the Ministry of Health to the site by typing in the study of 36 people, many of them on baraklyude can only guess, probably half. The other half - the mirklyudekse divided into three groups with different doses.
Will there be someone to take a survey? I think not, and so normal.
Will there be someone to take a survey? I think not, and so normal.
Positive outlook? :)
Hep b surface antigen quant is still not available in the US. And one company that does have it trades the test with a patient for a very large some of human plasma.
2. FibroScan is not available also
3. People with healthy livers wth twice the normal alt are routinely put on antivirals rather then interferon which is a better first line treatment.
4. Health insurance companies still deny people with hep b health insurance or impose treatment caps not to go over 75k. All of this is legal till 2014 at least.
Based just on what I have stated I dont know how can you be positive if you are a man. These kind of policies are for cattle not human beings.
5. Replicor has the best drug available. It works now. So why not give it to people? Do a good thing rather then trying to get the biggest dollar offer from a big drug company?. If they need funds they can come here and start raising them. Go to the people there is 300 million of us. But you dont see that instead they are developing it like a private corporate product. That with the given corporate bureaucracy may be available in 5 years. Yet the medication is ready today.
So then i can ask you how can I be positive and feel positive or anybody can be positive then companies try to profit on a cure development for one of the worst viruses the man had seen?
Hep b surface antigen quant is still not available in the US. And one company that does have it trades the test with a patient for a very large some of human plasma.
2. FibroScan is not available also
3. People with healthy livers wth twice the normal alt are routinely put on antivirals rather then interferon which is a better first line treatment.
4. Health insurance companies still deny people with hep b health insurance or impose treatment caps not to go over 75k. All of this is legal till 2014 at least.
Based just on what I have stated I dont know how can you be positive if you are a man. These kind of policies are for cattle not human beings.
5. Replicor has the best drug available. It works now. So why not give it to people? Do a good thing rather then trying to get the biggest dollar offer from a big drug company?. If they need funds they can come here and start raising them. Go to the people there is 300 million of us. But you dont see that instead they are developing it like a private corporate product. That with the given corporate bureaucracy may be available in 5 years. Yet the medication is ready today.
So then i can ask you how can I be positive and feel positive or anybody can be positive then companies try to profit on a cure development for one of the worst viruses the man had seen?
You need to have a more positive outlook. It is well documented that stress works negatively against the immune system. We all know how much you dislike government and the drug companies. Many people on this board have a positive outlook including studyforhope, andrey19, and StephenCastlecrag. Negativity doesn't do any of us any good.
Andrew, not to the end of 2012, and by 31 December 2013.
And do not test at all, and only this phase 2. And further more ambitious, the third phase, if the second is not oblamayutsya.
Try asking Markovu, gently, and how it will be generally available at the price.
And do not test at all, and only this phase 2. And further more ambitious, the third phase, if the second is not oblamayutsya.
Try asking Markovu, gently, and how it will be generally available at the price.
2017 that is crazy. By then many people will die.
People in our community have to be more active to get these drugs faster.
People in our community have to be more active to get these drugs faster.
Hi All
I recieved email around 2 weeks ago from Hepatera (company that develops Myrcludex B in Russia together with Germans). According to letter if all goes as scheduled they expect this drug to be available on the market in 4 years. Besides Hepatera was officially granted permission from Russian Ministry of Health on 21st Sept 2012 for clinical trials which according to that permission trials should be finished by 31 Dec 2012. So let's hope we all get rid of hep b pretty soon, not much time to wait !!! I am sure by 2017 we all be able to enjoy a glass of wine with hep b left somewhere in the past.
I recieved email around 2 weeks ago from Hepatera (company that develops Myrcludex B in Russia together with Germans). According to letter if all goes as scheduled they expect this drug to be available on the market in 4 years. Besides Hepatera was officially granted permission from Russian Ministry of Health on 21st Sept 2012 for clinical trials which according to that permission trials should be finished by 31 Dec 2012. So let's hope we all get rid of hep b pretty soon, not much time to wait !!! I am sure by 2017 we all be able to enjoy a glass of wine with hep b left somewhere in the past.
All this enthusiasm is not good enough.
These companies have the drugs and are introducing them way to slow.
A combination treatment myrcludex plus replicor that is at least 8-10 years away based upon how slow things progress.
But they should start giving it now. That would be a serious fight against hbv.
These companies have the drugs and are introducing them way to slow.
A combination treatment myrcludex plus replicor that is at least 8-10 years away based upon how slow things progress.
But they should start giving it now. That would be a serious fight against hbv.
It is hard not to share your enthusiasm. Hopefully, it will lead to an accelerated decrease of cccDNA, alone or in combination with other treatments.
Here is the most important aspect of this research:
These results show the dosing at which a saturation of liver binding sites can be expected. That is approx 3mg. Since a complete saturation is not necessary to cause a complete block of HBV entry, the truly required dose can be estimated to be in the range of 1mg or less. This was thus far just a wild educated guess, now it is established by exact measurement of PK parameters.I consider this a sensational breakthrough of this liver conference, since it places the Myrcludex treatment in a dose range that is doable and affordable and will work with clockwork certainty in humans to achieve the effect of complete blockage of viral spreading, and allow any processes of infected cell reduction to lead to a continuous decrease of cccDNA.
While the speed of such reduction will vary widely from patient to patient and depend on his HBV specific Tcell and other immune activities, it will lend itself to acceleration by interferon or even better by Replicor, which will open an attack on surface antigen specific epitopes that have not been used due to the blocking action of high levels of HbSAg.
These results show the dosing at which a saturation of liver binding sites can be expected. That is approx 3mg. Since a complete saturation is not necessary to cause a complete block of HBV entry, the truly required dose can be estimated to be in the range of 1mg or less. This was thus far just a wild educated guess, now it is established by exact measurement of PK parameters.I consider this a sensational breakthrough of this liver conference, since it places the Myrcludex treatment in a dose range that is doable and affordable and will work with clockwork certainty in humans to achieve the effect of complete blockage of viral spreading, and allow any processes of infected cell reduction to lead to a continuous decrease of cccDNA.
While the speed of such reduction will vary widely from patient to patient and depend on his HBV specific Tcell and other immune activities, it will lend itself to acceleration by interferon or even better by Replicor, which will open an attack on surface antigen specific epitopes that have not been used due to the blocking action of high levels of HbSAg.
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