Very glad to hear. Can't wait for more good news. Thanks for posting!
Any idea what this trial involves? What is it trying to establish?
Thanks
Thank you very much for this update, hope all goes on well with the trial. Back in Oct 2013 in the HB advocate article the company said they "hope the European study will be the last piece of confirmation work they would need before initiating the registration of this therapy (rep 9ac + peg + Nuc)". Anyone got an idea what this "registration of this therapy" means? and what's expected to follow after the European study, a Stage II clinical trial?
In the USA, companies usually file for a IND (Investigational New Drug) with the FDA. Replicor, being a Canadian company, the process may be different.
Stephen
What do you know about this European trial? What does it seek to establish? Is it a trial on nuc + inf + replicor as mentioned above?
Thanks
We have only one source of news - Christine Kukka from HBVadovcate. Yes, I think it will involve combining with the use of NA such as Entecavir or Tenofovir, just like ARC520.
I will be seeing the head of Gastro at my hospital next week if no one has any info before then I will find out what the conditions apply and post on here. Its goooooood news. Lets hope nothing dodgy happens or a petition might be on the cards :)
Does anyone know how a drug gets the status "exceptional circumstance" ??????
they may register in europe instead of US, it is cheaper and they can register as HDV cure.since hdv has not one single therapy that works they can have fast and cheap registration as orphan drug
i guess myrcludex is doing the same thing to get registration, marketing of the drug will follow registration
Which is your bet as the more potent drug of the two?
Thanks.
none if used mono, and both too little data to say
one thing is certain myrcludex mono is of very little use to clear hbv
Doesn't ARC520 target HBsAg too? If so, there are three potential new drugs that could be combined with nucs + inf in the future.
Of course, could well be that none of the three works even in combo.
I have got similar info from Replicor too, but they also suggester 2-3 years time to market as realistic.
Replicor have done it on humans and they seem more optimistic than the other 2 I guess time will tell
Soon people would have access to know more about rep9ac.
Another email, What it says"We are working on a redesign of our website and people will have the ability to provide their email address to receive future updates. This should be ready in about 1 week."
This Replicor situation makes absolutely no sense to me as it is potentially the biggest blockbuster cure that hardly anyone has heard of. From a purely profit based prospective why would a drug with a Trillion dollar potential (yes trillion) be so slow in development after the tremendous potential it has shown. With all the money being thrown around and the big pharma mergers proposed of late due to large pharma lacking pipelines, how has a Merck or Pfizer not approached the guys to gain the rights?
Something is strange here, I sure hope someone gets there crap together soon and moves this forward quickly in the near future
I AM WITH YA BUD! :)
I have been asking these same questions. I wish folks at Replicor would do things differently. The regiment with immune modulators works. They can save lives. Why only 10 people in the study? Why only in Europe?
:(
Something proper weird is going on.
Its not only Europe its only GERMANY. So anyone else is screwed!
To be honest it makes perfect sense to the drug companies flogging us NUCS!!
Replicor say its taking so long due to "Bureaucracy" Well I'd love to hear what that is.
I can only think something isn't right either with the product or circumstances surrounding my suspicion is the second one!
It seems like people with Hep B have just been stuffed in the background and forgotten about. If we complain or our voices we get a whole bunch of clever answers about how its very complicated bla bla and how we should be grateful that there doing anything at all.
Grateful? loads of people are dying but don't forget to be grateful! LAUGHABLE in the saddest possible way.
Replicor is clearly what we need but absolutely no one is interested keep the gravy train of cash flowing choo choo!!
I don't believe that there is some grand conspiracy going on with the drug companies, if there was Sovaldi wouldn't have seen the light of day.
I spoke to the CEO today and they will be starting in Europe this summer, he told me that many drug companies (including Gilead) have approached them but they want to see that it works and they aren't convinced as the last trial was run by Replicor themselves. For this trial Replicor will only supply the drug and researchers will run the trial. He also told me they are going to focus on HDV and use the orphan drug status to speed things along. He anticipates 20 weeks to results of the first two components of the trial, at that time they think big pharma will buy it and provide further development.
Great! , And few days ago Gilead reported $2.3 billions in sales of Sovaldi only for 3 first months on market. I think that researchers from Gilead will not let go easy when they will see results, and will expands trials all around.
Thank you for ringing and for the new information.
Hi Thanks for the info
Sorry if it seemed like I was ranting before I feel like I'm just getting so frustrated at the pace things move the longer we have this in our bodies the worse it is.
But this will be great if Gilead bought it and then took REP9AC' and expanded the trials and bought onto the market. that would be a weight of my shoulders as I'm sure it would be weight off everyone elses here to :)
Fingers crossed the phase 2 is as successful as phase 1.
No problem on the rant, I completely understand. I am fortunate to comfirm recently that I did not contract HBV as I was worried for quite a while. However I am very sympathetic to everyone here and I have learned a lot in the past 5 months.
I am considering a private investment in Replicor after I spoke I the CEO yesterday. I am happy for my money to help fund a new study to prove this drug works and speed the development of a potential cure. I also wouldn't mind making a few bucks in the process, it might make up for some of the anxiety of the past few months. I am going to call Michel back next week as I have a few more questions I have been compiling before I commit.
If anyone has anything they would like me to ask I would be glad to do so
Hi Yeah just ask him to hurry up and get it on the market lol
By all means as someone who suffers from hep b thanks for considering investing in a cure and I hope it works out mutually beneficial
Glad to hear your hep b is resolved by the way