Early stage compound knocks down virus in one dose

[mikesimon]

-Bristol compound potent against hepatitis C
Wed Apr 21, 2010 4:05pm EDT


(Adds details about Merck drug)

* Early stage compound knocks down virus in one dose

* Drug may be powerful addition in hepatitis C cocktail

By Julie Steenhuysen

CHICAGO, April 21 (Reuters) - An experimental Bristol-Myers Squibb (BMY.N) compound called BMS-790052 is proving to be the most potent yet at treating hepatitis C, an infection poorly treated with existing drugs, company researchers said on Wednesday.

An early, phase I safety study of the compound found it was highly effective at blocking the protein NS5A, a new target that might provide one more weapon against a virus that can quickly develop resistance.

"A lot like HIV, it is anticipated that a combination of at least three drugs will be required to prevent the emergence of resistance," said Bristol-Myers Squibb's Nicholas Meanwell, who worked on the study published in the journal Nature.

"We are targeting a different protein. This will provide a unique resistance profile," Meanwell said in a telephone interview.

Hepatitis damages the liver, causing chronic liver problems, liver cancer, cirrhosis and death.

It is the leading cause of liver disease worldwide, affecting an estimated 3.2 million people in the United States alone and 170 million worldwide.

Typical treatment involves 52 weeks of interferon plus the antiviral drug ribavirin. The combination works in only about half of all patients, and some develop such taxing side effects that they have to stop.

The Bristol-Myers compound works differently than a new class of drugs called protease inhibitors being developed by Merck's (MRK.N) Schering-Plough division and Vertex Pharmaceuticals Inc (VRTX.O) .

SUPPRESSING VIRAL LOAD

Meanwell said BMS-790052 helps inhibit the hepatitis C virus from replicating.

Infected patients who got a single 100 milligram dose of the compound saw their viral load -- a measurement of the virus in their blood -- drop more than 99.9 percent.

Early results of a phase II study presented last week at the European Association for the Study of the Liver in Vienna were also promising. Seven out of eight patients who got the highest dose of the drug had undetectable levels of the virus. The eighth patient had stopped taking the drug for a while.

"It's got potency and effectiveness in a single dose that is unmatched by anything else," Meanwell said.

He said the findings are very early, but the hope is that the compound could be used in a cocktail of drugs to keep the virus from developing resistance long enough for patients to clear the disease.

"The data we've seen so far is extremely encouraging," he said.

New treatments for hepatitis C infection have drawn much attention on Wall Street.

Vertex Pharmaceuticals' experimental hepatitis C treatment telaprevir, which is expected to have phase III results in the second and third quarters of this year, is projected to have peak U.S. sales of $3.9 billion in 2013, if it wins U.S. approval as expected in the first half of 2011.

Merck & Co, which is developing a rival drug in the same class called boceprevir, will present phase III results later this year.


See: http://www.reuters.com/article/idUSN2121908320100421?type=marketsNews

[Cory255]

The Bristol-Myers Squibb Compound called BMS-790052 is one of the many new potent drugs worth looking into.  

With data results like that (results of the phase 2 study, 7 out of 8 patients became UND) it will be no doubt in my mind avalaible at some point.

Thanks for posting!!

[orphanedhawk]

Yes!!!!!
The idea of being free of a disease that cost me my liver, is too good to be real.

Mike: You are the best at digging up information.

Eric: Thanks for reminding us to speak up.
I look forward to the day when I see/read/ hear even half as much publicly as I do about HIV.

[EricAgain]

There are some excellent replies here. Please consider posting your needs and frustrations on FDA's website. The pharmaceutical companies and FDA will read them. We do not have to agree on every point. As long as we testify for early, expanded access.  

If you do not wish to use your name, then use your Medhelp name or even anonymous. The cut-off date for public comments is this Friday, June 25.

http://www.regulations.gov/search/Regs/home.html#home

Type in search box: FDA-2010-N-0107

[GoofyDad]

BIG PHARMA.!

I love it that I can make you scream :)

[uncledudeness]

sorry I didn't see your response earlier. I just checked the website again, and it states the following:

http://clinicaltrials.gov/ct2/show/NCT01125189

HCV RNA viral load of ≥ 100,000 IU/mL

the criteria is greater than or equal to 100,00 IU/mL

I'm still looking for anyone that is enrolled in this trial. Please let me know if you are...

[Upbeat]

I checked out the trial conditions and they may have a hard time finding enough people. It looks like you need under 100k viral load to enroll.  I could be reading this wrong but I know of very few people with 100k or less viral load with chronic hecp c.

[Magnum]

Funny, but today I filled out some paper work to have ankle surgery and the pile of forms have three forms in particular that indemnify the doctor, the hospital and the insurance company of any and all liabilities. If this can be done in a three phase attack of non-liability for them, then why can't we sign a paper with the FDA and the pharmaceutical companies to provide the same out for them?

The AIDS medicines were put on a ver fast track. Doesn’t this problem with 170,000,000 people world wide infected with Hep C deserve the same fast track? Can it be that the pharmaceutical companies more than the FDA are frightened of not so much the pulling of the license if there are deaths, but rather the financial disaster of taking all the meds off the shelves and losing millions? Please answer this so I can sleep soundly tonight and have more faith in our system...

Mag

[Deb9991]

The biggest hurdle isn't so much with the drug companies, but with the American FDA.  This governmental agency is one of the most stringent in the world.  Drug companies have to demonstrate with a high degree of accuracy that their new drugs will show viable and theraputic effects that out weigh any harmful effects.  That is the main problem with getting these drugs, or any drugs, on the market.  Historically, there have been drugs that have been approved in the past that have later been withdrawn because of toxic effects -- this is a fact, however, I think that there should be a system put into place for certain drugs to be marketed for people who are staring death in the face and are willing to take whatever risks there may be in the hope that their medical condition could be cured or improved upon.  It certainly would have to be stipulated that critically ill people (and there are many) could take whatever experimental drug or drugs they needed that the drug companies are trying to market and accept the consequences regardless of the outcomes if there is even a remote possibility that such drug or drugs could save their lives.  In such cases, the responsibility would rest on the shoulders of the person who needs the drug or drugs to live and if such person dies or experiences ill consequences because of the experimental drug or drugs, then it is was their decision to make and not bureauocrates in Washington.  I sincerely believe it should be allowed, especially if a person has an incurable disease that will cause death without some new theraputic drug or treatment.  It is the lesser of two evils.  A legal document could be signed waiving any rights to sue for loss of health or life.  

It is better to try something than nothing.  

[Magnum]

Maybe, just maybe... this new potential entry will get the money grabbing pharmaceutial companies like Merk and Vertex to hurry up the licensing process, even if they have to grease some politician's hands (oh my, what a shocker that would be!!)...

Mag

[Magnum]

In line after JennyPenny. I'm going to see about ordering it for me JennyPenny and Susan tommorow. I may have a contact at Squibb. But... isn't it saying that it's part of a "cocktail"?!%^ Here we go again with the Riba torture...

"He said the findings are very early, but the hope is that the compound could be used in a cocktail of drugs to keep the virus from developing resistance long enough for patients to clear the disease".


Mag

[uncledudeness]

the trial was just listed: http://clinicaltrials.gov/ct2/show/NCT01125189

Official Title:   A Phase 2b Study of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

[merryBe]

cool, sign me the freak up!!!!!!!!!!!!

[Bali05]

gimme , gimme , gimme some , please !

[susan400]

I'm not offended!  I just was trying to make a point, that's all.  Susan400

[chuckles333]

What is the hold-up anyway? There are so many promising treatments just on the horizon but the horizon seems th move away as we go toward it. We have people who don't respond to SOC dying every single day. Why do we need to wait for the drug companies to beat the horse nearly to death before we are allowed to ride it. I understand that the drug companies do not want to be liable in case these new treatments do strange things to people but some people are desperate. Some would take any risk rather than face certain death. What is wrong with the society we live in? We place the greed of the business world above the need of the real world.

[nygirl7]

Volvic,

I'm sure susan didn't misunderstand you and wasn't offended.  She's not like that at all :)

deb

[volvic]

I am fully aware we all have different circumstances and live in different countries where medical coverage can be difficult or impossible to get.
My mail was referring more to the fact I am happy that we have pharma companies researching and developing drugs-medications which are of more benefit and realise not everyone can reap benefits immediately.
I can feel or you and your comment " I want that drug, sign me up for it!" we all want success and want and hope for when traditional combination treatment does not work hope.
let us just hope that you manage to knock this horrible bug and  allow others in the future to reap benefits of new medications.
There was no offence intended and wish you despite of the situation with your medical coverage all the best and eventual clearance.

[susan400]

The thing is that some people may not be able to wait for the new drugs as they seem to be taking a long time to get to the marketplace.  On top of that a lot of people will not be able to afford to pay for these new drugs.  I'm on a Medicare Advantage plan and their CURRENT drug formulatory only will cover Pegasys after the GAP.  Well unfortunately that means that you have to spend over $5,000.00 of your own money up front and then, the horrendous monthly co-pays for both the Riba and the Pegasys on this particular drug plan... that's not including rescue drugs costs and the NEW drugs on top of that.  With my currently being unemployed and my husband being under-employed there is no way in God's green earth that I will be able to afford anything coming out.  I need to be able to get accepted into a later stage clinical trial, which in itself will take another miracle.  One could say, "Oh, but wait, the gov't run health changes are coming..."    Well, that's another wait, possibly until 2014 and those changes are set to cut Medicare Advantage plans even deeper.  I don't mean to be casting a negative angle on all of this, but somebody needs to be realistic, too.  All of us aren't going to be able to halt our liver damage.  I have hope that I will and I pray that I will, but there are no guarantees in that.  There are others who are far worse off than I am, that won't be able to wait and I hope and pray that these drug companies will provide them with the compassionate care and ability to have early access to these drugs..., free of charge I might add.  Susan400

[volvic]

I am sure such a drug will not disappear from the market.
all drugs have copyright on them- other pharm companies will also develop similar if not better drugs. The advancement in hep c treatment  are there to stay. Treatment will become shorter, successul  and made available to all  those suffering from hep c.

[Linkjcfreak]

Do you think the drug company that sells Interferon and Ribavirin ( They get 4000 a month for my treatment) Is going to let another drug take money from them? I would bet this new drug won't be around for a long time.

[Diamando6]

Hey, this sounds grate, if this is true, we are almost cured, if we can wait untill all phases. But, lets first see what will happend with a drug, that is about to come 2011.

[Proactive]

It appears they are currently (still recruiting) running trials, excluding SOC- for relapsers
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01012895

This drug appears to have some high rvr stats

[nygirl7]

I dont think they are going to be able to get rid of the interferon for a long time - everything they are working on seems to be an addon like with the HIV drugs.

I'm afraid SOC will be around for a long time but at least the odds will be better and the times hopefully shorter!

[Proactive]

http://www.bms.com/research/investigational/hepatitis/Pages/BMS790052_easl.aspx