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Early stage compound knocks down virus in one dose
-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
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
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
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
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.
It is better to try something than nothing.
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
Mag
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
"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
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
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
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