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REP 9AC and Replicor

I have some feelings that Replicor might have ditch development of REP 9AC as so much has been said about it and nothing has happened in terms of making this magic cure HBV claimed drug available to patient. Is it to do with greedy as always by corporate organization? Surely someone should think of good name and history that comes with it. Lets write to Bill and Belinda gate foundation to speak to CEO of Replicor if this will help for guys in the USA.

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Avatar universal
If the results are very convincing, it might help with the systematic approval process in the US and the EU. I am sure, that a phase II and III trial according to the standards in the US and EU are still required. Big companies like BMS conduct trials worldwide under FDA supervison and get the approval process started simultaneously in Europe and the US.
Small countries might have different rules, they might give approval by endorsement after reviews of the data and trial results. Sciclones Zadaxin is an example where US approval was never obtained, but many smaller countries were systematically added to the list of approved. In the US the required phase III trial never took place and the situation was overshadowed by the famous Mutchnick randomized trial in the US that had, instead of confirming the original promising data for HBV treatment with Thymosin alpha shown no significant effect in the larger multicenter trial.
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Avatar universal
I was always curious about, since you are already explaining this, can you also please explain how this clinical trial in Bangladesh thing works? Lets say they successfully complete the trial and get all desired results & approval in Bangladesh in next 5 years, then how much more time does it takes to get approval in other countries?   Do they have to go through all clinical trials phases again? or after getting results from current phase, they would start clinical trials in other countries in parallel?
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Avatar universal
I didn't accuse anyone of anything, at least I hope I didn't. I was just sharing a few points that made me feel skeptical. studyforhope clarified some of my doubts in another thread.

Looking back I could have probably chose my words more carefully. I've ready many of your posts and you've provided a great amount of support to many people, I just think that none of us should get personal.

I think its good to debate points with the intention to reach a better understanding of a topic.

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Avatar universal
Thank you studyforhope, I read your response in this thread and the other one. Your knowledge of Replicor and optimism gives me reassurance that Replicor is in the works and could in the future help people.
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Avatar universal
"I AM ok with putting up $50 000 and going through replicor treatment. All done confidentially of course. But we dont see anybody from their company come here and have a dialog with patients".

Well if Repicor would come here publically and invite patients for non approved treatment protocols, then it would not be confidental anymore. The company would immediately be pursued legally and criminally and would likely have to shut down.

Furthermore, results obtained in such a way could not be used for the purpose of speeding up any legal application process.

The only way this would work is if they obtained approval in a small country , like Sciclone did it for Zadaxin and then patients would have to go there and unfortunately also have to pay out of their pocket. It is thinkable that Replicor might obtain early approval for this treatment in Bangladesch, since the local authorities have seen the impressive results and are therefore much more inclined to a speedy process.

Furthermore since the treatment is at least 6 month, as long as an  infusion weekly is needed, you would have to do that on your own. No doctor or clinic in the US would do it for you, not to mention the horrendous cost they would charge if they did.

Furthermore, how do you intend to monitor the results and your progress?
Since no quant surface antigen test is available here, you would not see the wonderful drop that you are likely to get after 6 to 8 weeks. Also your DNA curve needs to be monitored, as well as some safety labs that need to be followed.

You would need to introduce Zadaxin towards the end of the treatment at least, so you would need to get it from abroad, a difficult process. You could use PegIFN, but when to start it  is the question. Thus far no trial of a Replicor IFN combo from the start has been conducted, therefore it is unknown if this combo does not generate intolerable or truly dangerous side effects.

Your surface antibody has to be monitored as well, to give you an indication of when to stop treatment. It has to be quite high to give you a chance of durable SVR. And even that likelihood has not yet been established. In Amsterdam we will probably learn more about the current stability of SVR after immunenhanced Rep9ac'. But the time has not been long enough to make these SVRs a stable certainty.

Last not least , since you are e antigen negative, your chances to stably SVR are possibly substantially less than the currently investigated population of young e antigen positive patients, who have the reserve of core epitopes on their side for Tcell memory responses to hold the remnants in check. And you will have those remnants for sure , something has to permanently hold them back from regrowing. It has to be a combination of a strong antibody response together with the establishment of an effcient resident cd8 CTL Tcell memory population in your liver. There is no such thing as eliminating the last few HBV infected liver cells.

Thus how would you feel if after going through all these efforts you find yourself ,at a year after finishing treatment, with a rapidly rising surface antigen and viral load?

Also if you would continue the current antiviral during the treatment, you would not be able to see a DNA decline and as such you are pretty blind to monitor the true progress of your cccDNA elimination. Patients responded differently in the two previous trials and individual tailoring of stopping the infusions seems to be necessary to avoid a quick rebound.





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Avatar universal
No need to get personal-just read your posts. You make false accusation against a small company dedicated to finding a cure at their own expense and risk. This company is run by real people, you know.
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Avatar universal
The current.model of bringing drugs to market for diseases such as ours in NOT working.

As for frustration yes we are all frustrated. Replicor has the medication.that in combo with interferon or zadaxin cures. But we cannot try it or get it.  
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Avatar universal
You have to also keep this in mind. That just because some large drug maker have spend a ridiculous amount.of money on something that did not work. Does.not.mean anything. All those numbers are inflated do to the amount of people involved in these companies.  Gilead and BMS are like government agencies by staff  and affiliates they have to support. so money is wasted  in these companies.

A small company spending a fraction what they spend can be just as efficient. so dont just just things or efforts on the amount of money they have spend on something.
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Avatar universal
Come on guys, theres no need to start getting personal.

Any speculation is only from frustration of having the disease. having a very limited understanding on how drugs are brought to the market, and most importantly hope that your own speculation is wrong and there is in fact light at the end of the tunnel.
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Avatar universal
I AM ok with putting up $50 000 and going through replicor treatment. All done confidentially of course. But we dont see anybody from their company come here and have a dialog with patients.

Stefano is spot on with everything he is saying. big pharma is not interested in cures. As it will take out hbv  nucs market. Thus hurt their sales.

Bottom line folks we need to work out  a plan with Replicor to try this medication. Those of that can pay can try it and then spread the word that it works. And you will.see.funds will start to come in so everyone would be able to try it.

That is why I say and urge everyone on this board. To stop focusing on nucs
Lets focus on Rep9 and how to get it. There must be a way to have a dialog with Replicor folks. After all they are a private company. We are a group of private individuals that want to make a deal with them.

$50k per patient to complete the treatment course. And it does not have to be in the Western country.
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Avatar universal
Are they really big earner? Did you read about BMS spending 2.5 billion to acquire a drug that was supposed to be a cure for HCV, now they have to write off the whole amount as 9 people died in a further clinical trial? Gilead spent 11billion to buy a HCV drug , it is still not on the market.
If you believe in Rep9ac, put your hand in your pocket, if you don't, just carry on, it has not cost you anything.
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Avatar universal
They are waiting for people like you who believe they have a cure to put your money where your month is. Why is it that that others have to risk their money and effort while you just sit there and do nothing except to whinge?
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Avatar universal

hcv is different you can t have a drug to keep it under control and not cure, it can t integrate in dna and it mutates so mcuh more than hbv, they have no choice for it cure or no cure, no possibility of life long antivirals for it
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Avatar universal
Telapavir and Bocepavir are both cures for HCV and are big money makers in the USA.
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Avatar universal
I agree that it does take about 10 years to develop a drug but Replicor had been around for a while and conducted pre_clinical trial almost 7 years ago. They also added intf in an improved trial that proves to be success. What are they waiting for?
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answer is simple if they cure hbv there is nothing to make money on for the future......so they dont invest and this is partcularly true for US drug makers

the only news is myrcludex investment by russian government thanks god, i dont like US to invade/impose their patented products to all world markets
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Avatar universal
Why do you think Replicor  delay the product?
It always takes 10 to 15 years to develop a new drug.
I do not think that there is lack of investors in the market at the moment, if big pharmas do not want  to invest, there are so many venture funds. If they needed money they would fond it. Maybe the drug is not as good as we hope?  
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Avatar universal
Its true that Replicor had not applied for NDA for clinical trial but i would totally disagree with his/er view.
I think they might wish to use their drug for rich people that can afford it and operate as a special drug and will never apply for anything to any regulatory authority.
Surely, what is known about Replicor and REP 9AC out performed any known HBV medication ever, so continue delay of this drug is increasingly suspicious.
I read about Dr. Michael Weitz a Californian emergency room physician and how he overcomed cancer and his decision to enter a Phase I study - the earliest stage of human testing for a new medicine - of crizotinib currently marketed by  Pfizer as Xalkori after an unusually swift development process. ( http://news.yahoo.com/insight-cancer-drugs-proving-worth-earlier-testing-064332072--finance.html) .
This is completely opposite to the response received by Dynavax from FDA on HEPLISAV (HEPLISAV is an investigational adult hepatitis B vaccine) See http://investors.dynavax.com/releasedetail.cfm?ReleaseID=742656
It appeared that all odds are against any development in HBV or rather these new developments are being delayed because the big guys are playing catch up.
Make your mind up.
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Avatar universal
I totally disagree with your point about secrecy. Replicor has reported their results,albeit through posters, at all the major international Liver meetings. Please go to their website and read its news page.
You seek FDA's NDA if you intend to conduct clinical trials in America. Replicor never claims they have a magical cure. They report their results, they are confident that it is promising and are ploughing their own money and effort into developing it. They are not listed on the stock exchange so they don't hype. Is it their problems if big pharma don't invest in their product?
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Avatar universal
I am still not conviced that Replicor is for real. Big pharmacuticals would be banging on thier doors if they had a drug that really does what they claim to do in thier Clinical Data.

Here are the things that make me skeptical about Replicor.

1. They haven't gone through the FDA process for the intent of producing a drug for theraputic purposes. Granted they are in Montreal, they can apply some where to legally go through the process of promoting thier drug.

2. Thier drug costs $50,000 to produce and it is done through infusion

3. They have clinical data, but no collaboration with University Sciences. See their clinical data vs the clinical data presented by companies like Gilead.

4. They have not released a single drug of any sort, they have no reputation behind them

5. They supposedly have a magical drug, that no other scientist or pharmacutical company has been able to even come close to.

6. They are very secretive and moving at a very slow pace.

To me thier drug sounds too good to be true, and comes with some of the things above that make me skeptical about it.  Anyone can purchase a booth at the AASLD and present anything they would like.
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Avatar universal
:) too risky is living with hbv. That is a risk right there.
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Avatar universal
Probably it is too risky to test on 500 people at this stage...  
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Avatar universal
They have the drug. Look at their results. This is their phase 2 I believe.  It is really the best available seems to me.

What they have showed here is enough to go ahead and start using on human volunteers. 500 people they can easily gather locally  and give them the drug again for 12 weeks. If 90% clear hbv then there you have it. Real solid results. From there all doors will be opened.

All it takes is a will of the head of company to be different.  
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Avatar universal
I do not think that they can come up with the new drug faster than three years. What they have now is only the proof of concept that means that it theoretically works, but they do not know at the moment neither wright dosage nor side effects nor after treatment remissions etc. It takes to much time to test and define all that. If there are some sides that if most probable with a drug that actually integrates into your body they have to adjust the formula and do new trial etc. But I agree with you that if there is no such burocracy it could easily be 2-3 years instead 3-4.
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