Hepatitis B Community
Myrcludex B Trial Update?
About This Community:

This forum is an un-mediated, patient-to-patient forum for questions and support regarding Hepatitis B. Topics in this forum include but are not limited to, Causes, Diagnosis, Family and Relationships, Living With Hepatitis B, Research Updates, Treatment, Success Stories, Support, Symptoms.

Font Size:
A
A
A
Background:
Blank
Blank
Blank
Blank Blank

Myrcludex B Trial Update?

Hi Guys,
Anyone with update about Myrcludex B trial please update the community.
OCT has been awarded the trial but not much has been heard about the progress.
http://out-clinicaltrials.com/?q=content/oct-starts-phase-2a-multinational-clinical-trial-hepatitis-b-virus-infection
Blank
Avatar_m_tn
They will be doing trials in September in several clinics in Moscow. Now it is just naive patients. If the results are promising  it will be opened to many people. They are planning to do large clinical trials all over Russia. Not like here in USA 6 people and years in between stages.

Funds are provided in part by the government there so there will be control over quality and accessibility to the medicine for people that need it.

I really hope they succeed.
29 Comments Post a Comment
Blank
Avatar_m_tn
They will be doing trials in September in several clinics in Moscow. Now it is just naive patients. If the results are promising  it will be opened to many people. They are planning to do large clinical trials all over Russia. Not like here in USA 6 people and years in between stages.

Funds are provided in part by the government there so there will be control over quality and accessibility to the medicine for people that need it.

I really hope they succeed.
Blank
Avatar_m_tn
if it is promising .. booking ticket to moscow .. to join one group of trials ..
Blank
Avatar_m_tn
Thanks. Something to look forward for the results
Blank
Avatar_m_tn
I know we desperately need something.

All these companies take for ever their pipe line of new drug testing..
Blank
Avatar_m_tn
indirect update:

" Successful first administration of Myrcludex B, a first-in-class Hepatitis B and D Virus entry inhibitor, in humans " - this is the title for a presentation that will came in AASLD in November (no other info available at this moment)
Blank
Avatar_m_tn
wow this will take all other drug makers into hell, forcing them to open the hidden drawers
Blank
Avatar_m_tn
This is our only hope that they in Russia succeed.

You can bet that the hidden doors will be opened.
Blank
Avatar_f_tn
Hi 4est,
Where did you get the info about the Successful first administration of Myrcludex B in human?
I know OCT will be running the trial in Russia but not sure the progress.
References and update  will be appreciated.
Blank
Avatar_f_tn
Myrcludex B is being progressed quickly.
Fingers crossed.
Recent update for clinical trial published on 21Sept2012.

The company "Gepatera" Health Ministry received permission to conduct clinical trials
This was written in Russia.

http://maxwellbio.com/ru/news/244
English version:
he company "Gepatera" Health Ministry received permission to conduct clinical trials
September 21, 2012

Biotech company "Gepatera" created in late 2011 for the development and commercialization of innovative products for the treatment of liver diseases, has received permission from the Ministry of Health of the Russian Federation to conduct clinical research phase Ib-IIa drug Mirkludeks B (Myrcludex B) in patients with chronic hepatitis B .

Resident Biomedical Cluster "Skolkovo" Company "Gepatera" invested by venture capital fund "Maxwell Biotech", created with the participation capital of "RVC", is engaged in the development of drugs for the treatment of chronic hepatitis B and D Myrcludex B together with the German biotechnology company MYR GmbH, a portfolio by one of Europe's largest venture capital High-Tech Gründerfonds.

The prevalence of hepatitis B is very high: about 2 billion people worldwide are carriers of the virus, of which about 350 million are chronically ill. About 5% of patients with chronic hepatitis B to detect the presence of hepatitis D. This co-infection leads to more severe course and rapid progression of liver disease. At the moment, the majority of patients with hepatitis D capabilities of a specific treatment is limited or absent.

Myrcludex B, the idea of ​​which belonged to the 2nd largest European research institutes (National Institute of Health and Medical Research INSERM, France, and the University of Heidelberg, Germany), a peptide and to block the penetration of hepatitis B and D into normal hepatocytes (liver cells) , thus creating a reserve for liver tissue repair and prevent progression of the disease and the development of complications such as cirrhosis and hepatocellular carcinoma. This mechanism of action can hope for a cure of the disease after a limited course of therapy, which distinguishes the product from currently registered antiviral nucleotide analogs / nucleoside therapy which in most cases should be carried out for life.

Permitted MOH "Open randomized clinical trial of the drug daily Mirkludeks B (Myrcludex B) compared with entecavir in patients with HBeAg-negative chronic hepatitis B, Phase Ib-IIa» Company "Gepatera" plans to spend in specialized clinical centers in Moscow, St. Petersburg, Chelyabinsk and Samara.

Paul O. Bogomolov , Chief of Hepatology BWW MONICA named after MF Vladimir, head of the Moscow regional center of hepatology, hepatology chief of Ministry of Health of Moscow region: "Despite mass vaccination, an estimated 1.1 million people in this country each year require treatment of hepatitis B and D. Unfortunately, the current standard of care is not given the opportunity to fully address this serious medical and social problem. Based on the positive results obtained in the previous stages of the drug development Myrcludex B, we have every reason to hope that a clinical study based on a number of Russian centers will be successful. "

Alexander Alexandrov , Medical Director - CEO MYR GmbH: "This clinical trial will allow us for the first time to obtain data on the tolerability and potential therapeutic effect Myrcludex B in patients with viral hepatitis B in need of treatment. This is an important step in the development of the drug was made ​​possible through the fruitful cooperation with the company Gepatera and Maxwell Biotech Venture Fund is an example of successful cooperation between Russian and European real estate team. "

Ian V. Ryazantsev , Director of Investment JSC "RVC": "We are always pleased when portfolio companies are created with RVC, are key milestones in its development. Despite the fact that the company "Gepatera" was established long ago, such progress means properly structured strategy for the management of business processes in the company and the high competence of its management. Together with a team of fund "Maxwell Biotech" We look forward to the positive results of studies of the drug Mirkludeks B, which will significantly advance the search for solutions to such important issues as chronic hepatitis. "



About MYR, GmbH

MYR GmbH - a German biotechnology company founded in 2010 and has exclusive worldwide rights to the drug Myrcludex. The company successfully completed pre-clinical development stage and phase 1 clinical trials of the drug Myrcludex B. Currently, the company is responsible for coordinating the work of partners and contractors involved in the development Myrcludex, and collaborates with "Gepatera" in the conduct of clinical trials.

About "Gepatera"

LLC "Gepatera" - a private biotechnology company founded in 2011. The company is a biotechnology holding "Maxwell Biotech Group" and is a resident of the Biomedical cluster innovation center "Skolkovo". The main activity of the company - the development and excretion of the Russian market of innovative products for the treatment of liver diseases. The development of the first drug company Myrcludex B is in close cooperation with the German biotechnology company MYR, GmbH, a portfolio company of one of Europe's largest venture capital High-Tech Gründerfonds.


On the "Maxwell Biotech Group"

Ltd. "Maxwell Biotech Group" - a group of developers and service companies specializing in the development of innovative biotech projects. The company attracts funding and engaged in development and market introduction of innovative products and technologies, and actively participates in building an effective infrastructure for the development of innovative companies Our experience in international management team and experts and best management practices. To date, the assets of nine biotechnology projects: the company "OncoMax", "Photonics", "Metamax", "Infekteks", "NeyroMaks", "KardioNova", "Gepatera", "Osteros Biomedica" and "Eleventa." Seven companies of the group are among the residents of the Biomedical cluster innovation center "Skolkovo", 5 of them are members of the Technology Platform "Medicine of the Future."

Blank
Avatar_m_tn
The reason they are moving so at a good pace is because the russian government is funding Skolkovo initiative.

The projects are too big for one company to work on.

Here in the US they could do all this even better and faster if the US government actually  cared about people and actually doing something other then invest heavily only into military projects.

Just think about what Dr.Gish could do if he had this kind of funding available  to him and cooperation between Gilead and Replicor actually existed.

So yes it is very good what they are trying to do in Russia. Hbv must be stopped. And todays science can do it.  
Blank
Avatar_m_tn
I dont know how it works in USA, but in Europe the heatlh care is payed by our health insurance, so I think even our gouverments care to find a real threatments of the diseases because threating HBV, HIV etc. is very expensive for a state. And the grugs makers... yes, they care only about their astromonic profit but I think that they would make much more profit with a real threatment because the majority of their potential patients - in Asia, Africa, south America - will never have money to use ETV or others - but they would surely found a money to pay one therapeutic vaccine. Then I think that each (almost each) scientist would love to become historicaly famous by discovering a vaccine... the ego is in the game.  
Blank
Avatar_m_tn
In the US health insurance is operated by private companies. President Obama wanted to have a universal health care coverage system like you have in Europe but health insurance lobby really fight it. They have just about bought everybody from the republican party - and those people are pro corporate interest, pro big capital, over what is good for the people.

It is really bad here with health care if compared with everything else,

People experience issues getting access to treatments they need because the health insurance can always say NO you don't this treatment. And the doctors in states not only depend on the drug companies for bonus money, but also are controlled by health insurance in what tests to order and how to treat this particular patient. Some more some are less controlled. Depends how much you pay per month for your policy coverage

So for us here the health insurance issue is even worse then dealing with the drug companies. In fact drug companies in the majority of cases will provide medicine to a persons if they cannot pay for them. But health insurance company can still deny you health insurance  till 2014  law goes in effect that they cannot discriminate Hepatitis, HIV, diabetes patients etc. They have a whole list of disease based on which they can still deny you coverage. But it is getting better.. So in a way things did progress to better, people were not able to eliminate health insurance companies now but eventually in states there will be a government operated health insurance like you have in Europe..

I have experienced the worse of it about 4 years ago, cold sweat goes down my spine as I write it so I won't go into the details. But you can watch Michael Moore documentary film "Sicko" if you want to know what is really going on here with health care.
Blank
Avatar_m_tn
regarding astronomic profits you are right. Medicine has turned into hard core industry. But we the people take it. So we have what we have. Drug companies, health insurance lobbyist fight for every inch of their interests that is why they are winning because they are an active minority.

All this yes we all know we live in a very tough times.

I am more interested where and how we can help ourselves get access to medications that really work on hbv.
Blank
Avatar_m_tn
Somebody here said that the drug producers dont search the real medicaments, they want to keep people sick for long time because it is more profitable. I am not that pesimistic. There is a much more bigger sick population in Asia and Africa what has no money, no health insurance to pay parexample HBV long term treatment, so this population brings no profit for those drug makers. Even one shot of any ultimate treatment of HBV would bring them much more money in India parexample then in the whole west world. Then, those asian gouverments are also interested to keep the population healthy because it is a huge population, cheap population, population bringing the huge profits to the rich people of those countries. They need them working for the miserable saleries, buying their products etc.. I think it is the conspiration that drug producers see only the profit. Yes, they do but the west world is not interesting market anymore. They have to find a way how to threat poor people in undeveloped countries because it is really a huge quantity of the potential clients. In the west world there is much more other diseases what bring them anyway much more bigger profit then HBV or HIV. In fact I think they are personaly much more attached by searching something against HIV because majority of those rich men (drug makers) wants to have a lot sex without any risk. It is a pity that the Czech prof Holy died this year. He was the brain! He found lot of threatments for HBV, HBC, HIV etc. Hope his team will follow his way.
Blank
Avatar_m_tn
HIV is solved.. Bone marrow transplant is a 99% cure. Now only the really rich can afford it done. German clinics I understand are going with this treatment. 2 million euros per patient I understand in a research level facility is what it takes to be hiv free.

Here in the US they did also "cure" 2 people from HIV with this procedure that we know of. But for the rest of the people it will be antivirals for a long time to come. Unless they stand up to the insurance companies and force FDA to rethink their policy  to approve this treatment faster. Because it can be in a research category for decades.

We here in the US don't have a Fibro Scan approved yet, and hbsag quant is not available. You think this is normal and acceptable? And why is that? Because they are here are assessing success of treatment based on HBV DNA. You think can guess who might have lobbied to make this standard?

How people the like Dr.Gish can go along with this. And not to speak out against this system of corruption?   I asked this question many researchers here I seen. And didn't get a straight answer if any.

But forums like this open eyes to the public, and hbv folks that are not aware of what is available. How it is best to treat it even now and with what.

But corporate corruption and greed that turned medicine into business is sickening. Everyone is talking about it. So changes are coming  people just need not to stay silent. That is why I say we need all to write to these companies and ask them to come here. And answer some real questions how long this will continue?

For us HBV infected I think the biggest positive brake is that Myrcludex trial  has started off strong in Moscow. This will put real pressure on the US drug companies to roll out something similar. And if they don't in Russia they will do it. Then we all go to Moscow for treatment. They are putting some of best minds together under the Skolkovo project of companies. Not just in medicine, but in nanotech. There is a lot of possible now, with today's technology.

It is just governments must run these projects with finance money. Not private corporations that only have profit in mind.

This is what the doctors should be asking for as well. But they are going along with this system in fear to be ridiculed or loose a job.
Blank
Avatar_m_tn
Hepatera CEO interview about Myrcludex.

http://maxwellbio.com/ru/portfolio/hepatera/about

I believe news like this will make Replicor, Gilead and others move faster to develop new drugs.
Blank
Avatar_m_tn
I don't see why? Mycrludex can prevent entry of the virus into liver cells, but about already infected liver cells in chronic hbv patients?
Blank
Avatar_m_tn
Not sure why either.  Both drugs mentioned above are ahead of Myrcludex.  The GS-9620 results from Phase I/II are due next summer when Myr phase I/II is in December 2013.  I still believe Replicor needs to change their formula away from infusion to have a real chance of marketability.  Based on discussions on this board, Myrcludex has to be used in conjunction with others to clear HBV.  I don't think she disclosed any new information on the interview.  
Blank
Avatar_m_tn
you destroy the cells with some alcohol ::)) and block the new infection with Mycrludex    - just joking!

Indeed Mycrludex seams to be the best in combination with another drug that will clear some how the infected cells.
Blank
Avatar_m_tn
Maybe Replicor and GS-9620 drugs are ahead but it seems having positive results on papers is a very opposite thing from being even close to be  available on the market. How long do they have these results available inside the company? Anybody knows for sure? Replicor/Gilead/Hepatera are all competitors willing to get biggest hbv market share. The bigger number of real competitors we have, the more chance something good happen! I think coming news like that from each other will push them to move forward quicker rather then be sure no other company is doing anything for new drug development, so they can simply enjoy cashflow and wait for their patent to get expired and then come with a new drug right at that date. Another thing I am sure that Myrcludex gives more benefits to hbvers rather than Baraclude or Viread otherwise developing Myrcludex doesn't make any sence and frankly I do not care if I have to take Myrcludex together with other drugs if this is a way to get cured. Let's enjoy the news that Myrcludex trial is also going on and only time will show us which drug is ahead because the final point is to get on the market other than show positive trial results.
Blank
Avatar_m_tn
Yeah, I know what alcohol and how you use it too!  LOL.
Blank
Avatar_m_tn
Did not mean it as discouragement regarding any of these drugs.  I was merely implying that they are on the same schedule at this point.  We all would like the process to go faster so hopefully some will move along faster.  Competition is great and the first to finish line will be rewarded handsomely.  Next year should be full of updates on these candidates.    

From the current schedules, it appears that 2017 would be the year that some of these might make it to market.  Coincidence that Tenofovir goes off patent that year?  I'm not that cynical but it can be construed as tinfoil-hat time. (-:  I for one I'm glad these companies continue to invest on finding cures for HBV.      
Blank
Avatar_m_tn
HIV is not solved. Bone marrow transplantation (HSCT) is far too dangerous to be a treatment to cure HIV. It´s also impossible to find matching donors with correct receptors for all HIV-infected people. In fact HSCT might not be possible at all in a few years due to emeringing resistance problems among bacterias.

Regarding HBV we have the possibility already today to almost eradicate it within a few generations by preventing mother-to-child-tramsmission (PMTCT) and make sure that every child born gets vaccinated. In Sweden we estimate the cost for vaccination to be around $ 1 million/years to immunize to whole cohort born. If we have 0,1% of every child born on earth that would make around $ 1 billion/year to immunize every child in the world.

Compare that to what we gave the banks when they stole our money...
Blank
Avatar_m_tn
But those people that had their bone marrow replaced have no HIV.. And they can't find it. People got their weight back, and resumed normal life.

If now they are saying that "HSCT might not be possible at all in a few years due to emeringing resistance problems among bacterias" I would not be surprised, after all  HIV industry is very profitable. because the same  people run it as those that operate banks.

They have forgotten about Hippocratic Oath all together..

Immunization is all good.. But those of us HBV chronics want to live too. And they are taking that option away from us. The CEO's of these medical companies, the health insurance companies those that wrote eugenics regulations to slowly get rid of us while making money.

It is absurd when you have Replicor drug clearing HBV in as little as 7 days to 3 months not being given to patients that face liver cancer every six months - because they worry about us if it is safe.

Yet their laws are perfectly OK to allow health insurance companies to deny health care to people with HBV, and or deny access to treatments that cure it. Replicor issue as an Example of how corrupt and terrible things are. So it is far from good, just as bad as what is going on in the banking sector. But there is just money, here they are fooling around with people life's.
Blank
Avatar_m_tn
any comment..

Hepatitis B virus hepatotropism is mediated by specific receptor recognition in the liver and not restricted to susceptible hosts.
Schieck A, Schulze A, Gähler C, Müller T, Haberkorn U, Alexandrov A, Urban S, Mier W.
Source

Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany.
Abstract

The human hepatitis B virus (HBV) causes acute and chronic infections in humans and chimpanzees. HBV infects its hosts at minimal inoculation doses and replicates exclusively in hepatocytes. The viral determinants for the pronounced species specificity and the high efficacy to address hepatocytes in vivo are unknown. Previous findings showed that N-terminally myristoylated peptides constituting a receptor binding domain of the HBV large envelope (L)-protein block HBV entry in vitro and in vivo. Here we investigate the ability of such peptidic receptor ligands to target the liver. Injection of radioactively labeled HBVpreS-lipopeptides resulted in rapid accumulation in livers of mice, rats, and dogs but not cynomolgus monkeys. Without lipid moiety the peptide was excreted by renal filtration, indicating its possible retention through the lipid by serum factors. Organ distribution studies of 26 HBVpreS peptide variants revealed a correlation of HBV infection inhibition activity and the ability to target mouse livers. Together with complementary studies using primary hepatocytes of different species, we hypothesize that HBV hepatotropism is mediated through specific binding of the myristoylated N-terminal preS1-domain of the HBV L-protein to a hepatocyte specific receptor. Moreover, the restricted infectivity of HBV to human primates is not generally determined by the absence of this binding receptor in nonsusceptible hosts (e.g., mice) but related to postbinding step(s) (e.g., membrane fusion). Conclusion: HBVpreS-lipopeptides target to the liver. This observation has important clinical implications regarding the pharmacokinetic properties of Myrcludex B, the first entry inhibitor for HBV/HDV. In addition, this provides the basis for the application of the peptides as vehicles for hepatocyte-specific drug targeting. (HEPATOLOGY 2013).
Blank
Avatar_m_tn
Hepatology. 2013 Jul;58(1):43-53. doi: 10.1002/hep.26211. Epub 2013 May 15.
Blank
Avatar_m_tn
what is going on exactly in pharma on all so called promishing targets, so confusing what are they doing exactly and what exactly they want to do?
Blank
Avatar_m_tn
What do you think they are doing? :)

Same as always. They are hyping up their products with small and lengthy trials to get more money from the investors. The doctors and medical institutions that are in bed with big pharma also playing along to get grant money on a continuous base.

That is why I say they treat us like cattle. Replicor has something that works now that can cure people. Yet we dont have an access to it.
Blank
Avatar_m_tn
As for myrcludex - things are hazy with this drug. They took another 16 people to continue. But most people within Russia were not able to get into the trial. First  preliminary results that they have reportedly shows that it lowers HBV DNA by some degree  
Blank
Post a Comment
To
Blank
Weight Tracker
Weight Tracker
Start Tracking Now
Hepatitis B Community Resources
RSS Expert Activity
242532_tn?1269553979
Blank
How to Silence Your Inner Critic an...
Apr 16 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Emotional Eaters: How to Silence Yo...
Mar 26 by Roger Gould, M.D.Blank
1344197_tn?1392822771
Blank
Vaginal vs. Laparoscopic Hysterecto...
Feb 19 by J. Kyle Mathews, MD, DVMBlank