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replicor trial updates

http://replicor.com/replicor-present-updated-clinical-trial-data-combination-treatment-using-hbsag-release-inhibitors-patients-chronic-hepatitis-b-infection-10th-annual-meeting-oligonucl/

REPLICor to present updated clinical trial data with combination treatment using its HBsAg-release inhibitors in patients with chronic hepatitis B infection at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society.

Montreal, Quebec – October 1, 2014 – Updated clinical trial data from REPLICor’s three Asian trials using its nucleic acid polymer (NAP) HBsAg-release inhibitors REP 2055 (REP 9AC) and REP 2139 (REP 9AC’) will be presented at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS), to be held from Oct 12-16, 2014 in San Diego, CA.

REPLICor has currently tested its HBsAg-release inhibitor technology in three different clinical trials using different treatment modalities: in monotherapy, in combination with short term immunotherapy and in combination with a complete course of Pegasys™. Data presented by REPLCor during its presentation at the OTS meeting on Oct 15th will demonstrate 1) the unique ability of REPLICor’s NAP compounds to completely suppress HBsAg in the blood 2) the effect of HBsAg clearance on dramatically improving the activity of immunotherapy and 3) when used with a full course of Pegasys™, NAP therapy has resulted in the establishment of long term SVR in 80% of patients.

Link to the 2014 OTS meeting:

http://www.cvent.com/events/10th-annual-meeting-of-the-oligonucleotide-therapeutics-society/event-summary-a61fb28b01f84906845f05a247fcfb9b.aspx
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Avatar universal
Despite of knowing these won't come before 4-5years I daily search news for some hope n miracle. But all wane.
Steff said once hbv is already a dead disease now by newer generation already vaccinated and we will be dead sooner or later someday leading to eradication of hbv like small pox then y to invest on low profit business.
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Avatar universal
Ohh then it's a complication and we'll have to wait long long time. :'(
Another heart loosening aspect
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Avatar universal
They are not pushing hard coz they don't have enough budget, they probably might need some big pharma to purchase them.
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Avatar universal
Year by year is passing and they r still mum silent. What r they doing and where from r they getting money for such long time research n trial works without any business. It is like just investing, don't they want returns by releasing the drugs earlier.
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Avatar universal
my opinion is drug makers will have to fight like in a jungle between them and so take care to bring approval and low prices because there will be so much competition especially from "the soon out of patent tenofovir and peginterferon" which will be extremely cheap as generics

it is also possible the approval will never arrive because there will be little market if these new drugs wont be cheap
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Avatar universal
no way donations this is not smart:

we already have slow cures, so if rep9ac will be expensive few patients will be interested

if you donate you are not sure the drug will be on the market and will not reach US market for long unless they get US fda to approve

and when it will be on the market the cost will be very very high anyway.we had a post from a researcher many years ago, even copying the drug in another lab in israel or swiss cost is about 50.000USD
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9624973 tn?1413016130
it was this ideea before, i don't now if this can be done legally or if replicor would accept .
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Avatar universal
There are about 400 million victims of this disease and yet we were not able to lobby quick cure for this. I had a desperate idea, maybe we could donate $10 each to fund replicor and other promising trial to speed up the cure. Also, if successful we can lobby for the treatment to be affordable to poor victims so that everyone will get a chance to be healed. Someone has to come up with idea how to collect donations though.
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Avatar universal
we don't want baby drugs, they take 10 years going to market. Time for rep 9, arc 520, cuban vaccine to came out,
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9624973 tn?1413016130
“Our new therapy combines an existing anti-viral drug, which reduces the viral load, with birinapant that promotes efficient killing of hepatitis B infected cells and clearance of the virus from the system.”

is it promising ?
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Avatar universal
Another baby step...

http://hbvadvocat.blogspot.ca/2014/12/potential-cure-for-hepatitis-b-enters.html?m=1
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Avatar universal
Dear Stephen, Thank you very much for your views.
It is frustrating that people like me with HBV are eagerly waiting for a breakthrough and when it seems there has been one...there is no progress for a long time and we are totally helpless :(
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Avatar universal
all drugs companies not interested since about 10 years and keep studying on failure drugs, this is why we say they are not interested in hbv cure for now
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Avatar universal
No idea. Studyforhope did make an informed guess, not cheap. My feeling is that, with mass production it can be made cheap. Think of your personal computer, it is like buying a Roll Royce for $5 - and this was said over 10 years ago.
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Avatar universal
Lets say replicor eventually launches the drug to the public.

How much would you guess a patient may have to fork out for a complete course of treatment?
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Avatar universal
It was in relation to that presentation at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society, by Andrew Vaillant, that I sought clarification from Replicor.
Anyway, that presentation did cause quite a stir for the commentators at the meeting where results of several HBsAg knock-down RNAi drugs were presented. They paled in comparison to the knock-down achieved by REP9AC (1 - 2 logs against 5 logs).
"Investors are also likely to be curious about private company Replicor, which has "shown some hepatitis B data that I can only characterize as really fantastic," Skorney said. "Most investors are scratching their heads if it can even be real," he said, noting the company has only a handful of employees and very little capital, and ran its study in a developing country."

Let's hope someone will get moving.
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1024307 tn?1291998486
Thank you Stephen.
What confuses me is the statement prepared for The 10th Annual Meeting of the Oligonucleotide Therapeutics Society, by Andrew Vaillant,(Ph.D.
Chief Scientific Officer REPLICor Inc), where he describes SVR as HBV DNA < 20 copies / ml, off treatment. Wouldn't be more clear to state,what you have found out from the private correspondence? Anyways, thank you, Stephen.
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1024307 tn?1291998486
Thank you Stef.
I understood that once HBsAg is undetectable,that means removed=no more HBV. Therefore HBV DNA naturally undetectable.
I was away from the forum for couple of years and missed a lot. Nice to see familiar names still helping others.
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1024307 tn?1291998486
The drug could also be bought by another, large company. As it was with the new drug for HCV (sofosbuvir) and Pharmasset.
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Avatar universal
No, I don't have any information from Replicor.
Speaking for myself, I don't think it is up to Replicor to set a time table. It is my belief that Replicor always wanted its drug candidate to be made available to the public as soon as possible. But for that to happen, it must have regulatory approval that requires a series of costly clinical trials. Replicor had demonstrated in their own small clinical studies that REP9AC has the potential to provide a cure for HBV. It would be nice if other pharmas or substantial investors  can invest and push this further. Replicor is keeping the hope alive by trialling REP9AC as a treatment for HDV/HBV co-infection. It may be able to gain fast-track approval as an orphan drug.
Just my personal opinions.
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Avatar universal
Dear Stephen, Was there any indication from Replicor on their timeline/plans of market release
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Avatar universal
I had sought clarification from Replicor. In a private correspondence, Replicor stated: "Our definition of SVR include HBsAg not detectable ie less than 1 IU/ml."

Hope that helps.
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Avatar universal
it is the opposite from all other drugs, they can clear hbsag but no activity on hbvdna.after the drug has removed hbsag and made hbsab our immune system should activate and keep hbvdna und for this they use pegintf add on for 48 weeks and the result is 80% hbvdna und

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Avatar universal
it is not like all other therapies

nap from replicor clears hbsag in few weeks and makes hbsab detectable, which in turn lowers hbvdna to almost undetectable.their point by clearing hbsag is activating immune system to see if it can keep hbvdna und when hbsag is und.so here they report on hbvdna follow up

their point is keeping hbvdna und off thereapy here
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