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ARC-520 phase 2 update from RBC

4 mg/kg safe in healthy phase 1 extended trial, this shows they are able to use higher doses safely. Still not approaching anywhere near toxic levels, this is good for other diseases as well that can be treated by DPC's. 3 mg/ kg phase 2 extension shows KD of long duration like 2 mg/kg at 1 dose, also could be bi-phasic reduction as a result of immune reactivation. I would expect a company release soon on this including the raw data

31 Responses
Avatar universal
This note was from Michael Yee who is widely considered to be the top biotech analyst on wall st. He also went in to say that ARC-520 has the potential to cure by itself or in various combos and we will learn a lot more after phase 2b results are gathered next year
Avatar universal
Great!! Do you have any link to read this?
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What does a wall street biotech analyst is doing around hbv cure?  
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From Dirk Haussecker's Twitter

ARWR 4mg/kg safe in healthy volunteers would be huge news considering preclin dose-response. I'm all excited RE prospect of ARC520
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I hope they can save us all from this Nightmare!
Avatar universal
RBC Capital Reiterates Outperform Rating on Arrowhead Research (ARWR)

7:39 AM ET, 09/17/2014 - StreetInsider

RBC Capital maintained an Outperform Arrowhead Research (NASDAQ: ARWR) with a price target of $35. Analyst Michael J. Yee thinks Street interest in Hep B is just getting started, and upside should be significant. "Investors are looking for the next big market after Hep C and that could be NASH (ICPT, GILD, GenFit) or Hep B. On the road w/ mgmt we learned 1) Phase I now through high dose 4mg is safe in healthy pts, 2) Phase II in HBV now dosing 3mg clearly shows knockdown including long duration effects after just one dose .could be "bi-phasic" reduction and immune system already starting to work (no ALT flair expected), 3) higher doses could get even better, 4) multiple doses could have more effect, 5) ARC-520 could be complementary to peg-interferon, or other approaches (KOLs say this will be a long-term combination just like Hep C .)," said Yee. The company has many ways to win, continued Yee. "They could have cures and/or ARC-520 could play a role in a future combination. We will continue to follow other very early-stage companies with a different approach that could be complementary : OnCore Biopharma (entering Phase I in 2015 " email us for poster), Novira (Phase I), Assembly Pharma (entering clinic 2015), Replicor (Canadian biotech). We like ARWR into AASLD and long-term not only because we believe Street interest is going to pick up in 2015 with these companies seeking the next big thing but also because we believe upside for ARWR should be quite significant if Phase IIB shows cures , and adding combos means many shots on goal. It s not yet confirmed we'll get the key placebo-controlled Phase IIB data in 15 (keep it blinded for a year), but many Phase II open-label studies will be going on with possible data."
Avatar universal
Because Arrowhead is a biotech company and like it or not they need money to keep funding the research into ARC-520 and other drugs to treat many previously untreatable diseases. There is a reason that over 90% of all new drugs come out of the US
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So when are we expecting the cure to reach out to us?
Avatar universal
I think it is too early to jump to conclusions. These analysts, though they are well informed, are not Hepatitis B researchers or experts. However, it is good that other companies, such as Novira (capsid inhibitor), Assembly (CpAMS, capsid inhibitor), Oncore (Cyclophilin Inhibitors), and even Replicor are getting attention.
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It is your thinking from you brain
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Arrowhead to Present at BioCentury’s NewsMakers in the Biotech Industry Conference

Avatar universal
Cures are already there. They are just waiting to suck more money out of nucs as possible. Hiding behind these bogus clinical trials that are about nothing really but only raise the costs of drugs when they get approved.

System is old and outdated. It needs to be changed first.

And it can be changed if we all customers go on strike and stop buying and using these drugs and tell our doctors to tell them to release a cure. If we can do an action like this. I guarantee you in few months HBV cure cures. New drugs will be offered.  
Avatar universal
I dont know brother.... but i really believe that npv018 will teh cure drugs for hbv. Why i believe on it, because oncore biopharma buy it as a pipe line... oncore biopharma is the one that create sofosbuvir and sovaldi... we really need to watch them... i bet it will success as a hbv cure drugs
Avatar universal
I would love to try sofosbuvir and sovaldi myself and see if it can knock out HBV. Some say they can too.
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Please do, it is 1,000 USD per pill, take as many as you like. Your big pharma friend Gilead would love you. Of course, Gilead will be disappointed that you are not taking their Tenofovir, one of the NUCs that you hate.
9624973 tn?1413019730
Were there trials on sovaldi on hbv pozitive? Is it working ?
Avatar universal
Not that I am.aware of but definetely worth a try. I have heard opinions from some doctors that it may actually work for us too.  
Avatar universal
Stephen. I dont hate antivirals. I took it remember for seven years. And got some very nasty sides do to.toxicity these drugs have and cause over a long period if use. I dont hate them or big phrama I am just aware of the short comings these drugs produce. They really only block viral assembly and cant stop.the virus as interferon can. The facts are there. That interferon produces better results in 1 year then any nuc combined. So naturally comes the question then why in the first place use anti HIV meds with us who are hiv negative?

I do question for what reasons were these meds approved to treat HBV and others like Alinia and Zadaxin were not. Why very affective interferon therapy of the past that is proven is being used less and less. Why we hbv infected are told we need life time treatment?

Avatar universal
I reject completely your backtrack on your claims about NUC, big pharma, and Interferon.
We all know that the current antivirals cannot cure, but they are very effective in stopping the progression of liver diseases due to Hepatitis B, in some cases, they can ever reverse cirrhosis/fibrosis, thereby reducing the risks of HCC. Sure, they have to be taken long term, but they save life. Just like medications for controlling blood pressure, diabetes, epilsey etc, they all don't cure, taken long term, and yet they are absolutely essential for the patients.
Yet you advocate patients to stop or not take NUC in order to force/blacklmail their doctors to release an imaginary cure of yours. You are asking patients to put their well being at risk for a cure that does not exist?
You complain bitterly about the side effects of NUC, yet you failed to mention the potential serious side effects of Interferon, such as depression, lower while blood cells count and others, especially the ALT flare they may be dangerous. That is why Interferon is contraindicated for patients with acute Hepatitis B or de-compensated liver disease. You ignore all that, and blatantly claimed that Interferon can cure, BUT it is only in a small percentage of patients that Interferon can cure. So there are risks and benefit to consider, and they are best considered by doctors in conjuction with the patiients. Any you are not even a doctor, and have you had personal experience with Interferon treatment?
Now you are even advocating the quacklery of ozone, vitamin treatment with Interferon!
There are many HIV medications not approved for HBV for the simple reason that they are not effective. Those HIV medications approved for HBV had to undergo clinical trials to prove their safety and efficacy for HBV before they are approved, unlike your ozone and vitamin treatment.
You complained that drugs like Alinia and Zadaxin are not approved for HBV, yet you decried the process of clinical trials to prove safety and efficacy by saying they are used by big pharma to block and delay the release of your imaginary cure. So, you alone can determine which drugs are cures, which drugs do not require clinical trials. Where is your evidence?
You spread the dangerous idea of patients not to use existing drugs because they cannot cure by falsely claiming there are "drugs" that can cure already. This is grossly misleading, irresponsibly, and outright dangerous. It is like cutting your nose to spite your face.
Now you are also advocating HBV patients to abstain from sexual activity and lead a normal life until your imaginary cure is released. You damn well know with current treatments and vaccination, HBV patients can lead a fully normal life and present no harm to their partners and family. Shame on you.

You should be BANNED from this forum because you tell lies, cause unnecessary alarms to patients and the public, undermine the good reputation of this forum hard earned through the tireless effort of some like stef2011.

You should retract, apologize and leave.
9624973 tn?1413019730
I dont understand you guys now, stef2011 sais that after many years (3-5-10)of tenofovir use, it is possible you can cure hbv, you now you say that it is not possible.and also that a potential cure does not exist, replicor has a very potent drug..lets not minimize or pretend it doesnt exist.. veteran, what did you took 7 years? And what was the result of your hbsag?
Avatar universal
Stef2011 is correct but you are miss-interpreting his words. He strongly advocates, and I fully support his view, that after several years of POTENT antiviral treatment, resulting in UNDETECTABLE viral load over a period of time, WITH LOW (< 1,000 iu/ml of serum HBsAg), THEN add-on with Interferon can GREATLY INCREASE the chance of s-seroconversion.
His views are based on reading of the current scientific literature, discussions with his researcher friends, and his own observations.

The science behind his view is very sound:

UNDETECTABLE viral load means very little or no replenishment of the cccDNA pool, and removal of one inhibition factor, the serum hbvdna, of the immune system.

LOW HBSAG reflects a diminishing pool of CCCDNA, and removal of another inhibition factor(serum HBsAg) of the immune system.

ADDING INTERFERON now will further reduction of  qHBsAg and boost the innate immune system.

HENCE the highest chance of s-seroconversion by our immune system.

I think stef2011 favors this natural reduction of qHBsAg as it implies less transcriptional active cccDNA and or a smaller pool of cccDNA. In contrast, REP9AC and ARC520 can cause of knockdown of a large cccDNA pool for a short period of time. It is hoped that during this window period, our immune system can kill and cure the infection. This hope is raised by the clinical data from a small set of patients provided by REP9AC, BUT must AWAIT confirmation in larger patients population.

This is I believe is his position, very sound, not raising false expectation, and certainly will not put the health of the patients at risk.

So do please read all his posts carefully. I do.
9624973 tn?1413019730
I am trying to read all his posts, there are a lot. I understand now what did you said. Also, i have a question, after tenofovir use of a few years, normally not everyone should have undetectable hbvdna and hbsag going down?of course, everyone is different so some may be slower, some faster. I wanted to now if there are resistant pacients at tenofovir lets say
Avatar universal
The response to any medication depends on interaction between the drug and our body's own environment. That is why drugs must be tested in a large sample of patients. It may work for you but harmful to other. Equally, it may be harmful to you but beneficial for others.

After 7 years, no resistance to TDF has been reported. Equally, if you read the scientific literature carefully, no-one claims TDF will reduce hbvdna to undetectable for 100% of patients, but over 90% will. Don't forget all drugs have side effects, including Interferon.
Avatar universal
As for the lowering of HBsAg from prolonged usage of TDF.  I am not an expert, but this is what I read from the researchers:

During TDF therapy, loss of qHBsAg is due to loss of cccDNA. How? TDF does not affect cccDNA latent in the nuclesu of infected cells. One explanation offered by the researcher is that cccDNA is lost during natural turn over of infected liver cells (all cells in our body, perhaps with the exception of cells in the brain) die and replace by new ones. So these researchers speculated that a slow decline in qHBsAg may be due to hardy infected liver cells that never turn over or very slowly.

A second reason is that , in my view, our immune system can kill and/or cure cells of cccDNA. Immune system is very complex, they  are the results of our genes. So this is the short answer that we don't know why some can reduce qHBsAg quicker than others.
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