AASLD:Making News Hepatitis C Drug:TMC435
- File Under Investment News HCV Drugs, TMC435
Painting By G. Harvey .
I wanted to make mention today about an on going entry here on the blog. *found on the sidebar. " Hepatitis C Drugs and Wall Street " Is updated as investors publish new articles of interest on their websites.
I wanted to make mention today about an on going entry here on the blog. *found on the sidebar. " Hepatitis C Drugs and Wall Street " Is updated as investors publish new articles of interest on their websites.
*keep in mind that this is only another resource for news, and looking at the data coming from the AASLD is reliable and much more comprehensive.
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In Case You Missed It:
At the end of October over at shearlingsplowed the blogger gave a nod to Adam Feurstein, who reports for TheStreet.com. The link to Mr. Feursteins original article was added to HCV Drugs/WS .
In Case You Missed It:
At the end of October over at shearlingsplowed the blogger gave a nod to Adam Feurstein, who reports for TheStreet.com. The link to Mr. Feursteins original article was added to HCV Drugs/WS .
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He writes; Adam Feurstein, writing for TheStreet.com, has done a nice job of summarizing the next-gen Hep C "state of the play" -- as to the most important candidates in Boston, at the big liver conference "Because there will still be some patients who won't respond to Telaprevir®, or Boceprevir®, J&J (via a The Medicines Company-researched drug candidate, thus the TMC nomenclature) is advancing a powerful alternate candidate, still about four years away from market, to follow in Telaprevir's wake:
. . . .In addition to partnering with Vertex on Telaprevir, Johnson & Johnson is developing its own Hep C drugs, including TMC435. A phase IIb study being presented Monday shows that between 79% and 86% of patients treated with TMC435 and standard of care responded well enough to stop all therapy after 24 weeks. This interim result for TMC435 looks better than the 58% and 65% of telaprevir-treated patients who were able to stop therapy after 24 weeks, except that J&J used a more liberal definition of response, which inflates its numbers. Patient treated with higher doses of TMC435 also reported increases in certain liver enzymes levels, raising safety concerns about the drug. . . .So, the Vertex juggernaut in Hep C may only last for about five years -- but that will certainly be "enough" -- enough to clearly label Ex-Schering-Plough CEO Fred Hassan's Boceprevir as primarily a second-line "me too" candidate. We'll keep you informed.
From Medpage :
. . . .In addition to partnering with Vertex on Telaprevir, Johnson & Johnson is developing its own Hep C drugs, including TMC435. A phase IIb study being presented Monday shows that between 79% and 86% of patients treated with TMC435 and standard of care responded well enough to stop all therapy after 24 weeks. This interim result for TMC435 looks better than the 58% and 65% of telaprevir-treated patients who were able to stop therapy after 24 weeks, except that J&J used a more liberal definition of response, which inflates its numbers. Patient treated with higher doses of TMC435 also reported increases in certain liver enzymes levels, raising safety concerns about the drug. . . .So, the Vertex juggernaut in Hep C may only last for about five years -- but that will certainly be "enough" -- enough to clearly label Ex-Schering-Plough CEO Fred Hassan's Boceprevir as primarily a second-line "me too" candidate. We'll keep you informed.
From Medpage :
AASLD: TMC435 Rapid Response for Once-Daily Protease Inhibitor
excerpts:
"In an interim analysis of a phase IIb, five-arm trial, genotype 1 hepatitis C patients taking various doses of TMC435 in addition to peginterferon and ribavirin had significantly greater responses at four weeks than those on combination therapy plus placebo (68% to 79% versus 5%), according to Michael Fried, MD, of the University of North Carolina Chapel Hill, and colleagues"
"There were no differences in adverse events, including rash, anemia, or gastrointestinal events, and the most common effects were headache and fatigue, which were comparable across all groups. Discontinuation rates were similar across all groups as well.There were, however, "small and transient" elevations in bilirubin levels for patients in the 150-mg dose groups, which Fried said resolved after treatment ended."We see some increase in bilirubin, but it's completely reversible," he said, adding the effects are "clearly related to a transporter mechanism as opposed to hepatotoxicity."He added that despite these effects, "in my opinion, the 150-mg dose is probably the way to go." Full Data
AASLD:TMC435 PILLAR study in treatment-naive patients/ genotype 1
The results showed that in the four TMC435 treatment groups between 79 and 86 percent of patients were able to stop all therapy at Week-24, according to the response criteria defined in the study protocol. There were no relevant differences for adverse events between TMC435 treatment groups and placebo. TMC435, a hepatitis C protease inhibitor, dosed once daily (q.d.) is being developed jointly by Tibotec Pharmaceuticals and Medivir.
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Todays AASLD Updates:
AASLD:SVR for hepatitis C boon to patients 20 yrs down the road
Check Back For Links and Updates @ Hepatitis C Drugs and Wall Street
excerpts:
"In an interim analysis of a phase IIb, five-arm trial, genotype 1 hepatitis C patients taking various doses of TMC435 in addition to peginterferon and ribavirin had significantly greater responses at four weeks than those on combination therapy plus placebo (68% to 79% versus 5%), according to Michael Fried, MD, of the University of North Carolina Chapel Hill, and colleagues"
"There were no differences in adverse events, including rash, anemia, or gastrointestinal events, and the most common effects were headache and fatigue, which were comparable across all groups. Discontinuation rates were similar across all groups as well.There were, however, "small and transient" elevations in bilirubin levels for patients in the 150-mg dose groups, which Fried said resolved after treatment ended."We see some increase in bilirubin, but it's completely reversible," he said, adding the effects are "clearly related to a transporter mechanism as opposed to hepatotoxicity."He added that despite these effects, "in my opinion, the 150-mg dose is probably the way to go." Full Data
AASLD:TMC435 PILLAR study in treatment-naive patients/ genotype 1
The results showed that in the four TMC435 treatment groups between 79 and 86 percent of patients were able to stop all therapy at Week-24, according to the response criteria defined in the study protocol. There were no relevant differences for adverse events between TMC435 treatment groups and placebo. TMC435, a hepatitis C protease inhibitor, dosed once daily (q.d.) is being developed jointly by Tibotec Pharmaceuticals and Medivir.
.
Todays AASLD Updates:
AASLD:SVR for hepatitis C boon to patients 20 yrs down the road
Check Back For Links and Updates @ Hepatitis C Drugs and Wall Street
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