Replies to post #36015 on Biotech Values

[DewDiligence]

>…the [Peg-Intron] label for second-line use must mean that there is sufficient trial data to support the hypothesis that non-responders to Pegasys are more likely to respond on a second try using Peg-Intron<

That’s my understanding.

> I'm thinking about this again in the context of the 'creative approach' IDIX has promised in dealing with non-responders in upcoming trials. One possibility I suggested previously was designing a trial (or trials) where non-responders to one type of peg-ifn are treated with NM283 plus the other type of peg-ifn, compared to a control arm w/o NM283, both w/ or w/o riba depending on the results of riba interaction studies. The other option is to use a combo of both peg-ifns, using around a half-dose of each<

This might work, but I’m hoping what they have in mind is somewhat more “creative.” We should know the answer within the next week.

[DewDiligence]

It looks like SGP may be angling for a second-line
HCV label in the U.S. (to complement the second-
line label Peg-Intron already has in Europe). From
today’s PR:

http://biz.yahoo.com/prnews/061024/nytu046.html?.v=70

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Among the key presentations [at AASLD] will be data from the EPIC3 (Evaluation of PEG-INTRON in Control of Hepatitis C Cirrhosis) study, a large, prospective, controlled clinical trial designed to assess the safety and efficacy of PEG- INTRON and REBETOL in retreating patients who failed previous alpha interferon and ribavirin combination therapies, including peginterferon-based combination therapies.

Investigators for WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL), the largest community-based clinical study in hepatitis C ever conducted in the United States, will present results in patient populations traditionally considered hard to treat, including elderly patients and Hispanic patients.
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[rsox]

repost of idix msg....

[DewDiligence]

Here are the second-line Peg-Intron data from
SGP. 23% of patients who failed first-line SoC
treatment with Pegasys had an SVR on Peg-Intron
+ ribavirin, which is impressive, IMO.

http://biz.yahoo.com/prnews/061027/nyf033.html?.v=73

>>
Results of PEG-INTRON® and REBETOL® Study in Retreating Hepatitis C Patients Who Failed Previous Combination Therapy Presented at AASLD

Friday October 27, 8:30 am ET

BOSTON, Oct. 27 /PRNewswire-FirstCall/ -- Schering-Plough today reported data from EPIC3, a large ongoing clinical study, showing that retreatment with PEG-INTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) combination therapy can result in sustained virologic response(1) (SVR) in patients with chronic hepatitis C who failed previous treatment with any alpha interferon-based combination therapy, including peginterferon regimens. In this study, 56 percent of patients who had undetectable virus (HCV-RNA) after 12 weeks went on to achieve SVR with a 48-week course of therapy. Of the first 1,354 patients retreated, approximately 38 percent had undetectable virus at week 12. Importantly, patients who did not have undetectable virus at 12 weeks had little chance of achieving SVR. Overall, 23 percent of patients achieved SVR.

"The ability to predict efficacy of retreatment early in the course of therapy would assist physicians in managing this hard-to-treat patient population," said Eugene R. Schiff, M.D., chief, division of hepatology and director, Center for Liver Disease, University of Miami Miller School of Medicine, and co-lead investigator of the EPIC3 study. "These results suggest undetectable viral load at week 12 defines an early virologic response that predicts SVR for patients who failed previous combination therapies and are retreated with PEG-INTRON and REBETOL."

Data from the EPIC3 retreatment study are being presented here at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).(2)

"A large and growing number of patients who failed previous HCV therapy are in need of viable treatment options," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "The results of this study demonstrate that retreatment with PEG-INTRON and REBETOL combination therapy may help address this unmet medical need in this difficult-to-treat patient population."

Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and is a significant healthcare problem worldwide. The current standard of care for treating chronic HCV is the combination of peginterferon and ribavirin, which achieves SVR in approximately 50 to 60 percent of patients overall.(3,4)

EPIC3 Data Presented at AASLD

EPIC3 (Evaluation of PEG-INTRON in Control of Hepatitis C Cirrhosis) is a large multicenter global clinical study program involving a total of more than 2,200 patients at approximately 140 sites worldwide. The program includes a global, multicenter, open-label, single-arm prospective study designed to assess the safety and efficacy of retreatment with PEG-INTRON and REBETOL combination therapy in patients with moderate-to-severe fibrosis (METAVIR F2- F4) who failed previous treatment with any interferon-alfa plus ribavirin combination therapy, including peginterferon-based regimens (peginterferon alfa-2a or peginterferon alfa-2b). In this non-comparative study, patients were retreated with PEG-INTRON (1.5 mcg/kg once weekly) in combination with weight-based dosed REBETOL (800-1,400 mg/daily) for up to 48 weeks. The primary end point of the study was SVR, defined as undetectable plasma HCV-RNA 24 weeks after the end of treatment. An aim of the study was to further characterize early viral response at week 12 as a predictor of SVR in these patients.

The data presented at AASLD included safety and efficacy results for the first 1,354 patients retreated in the study. Of these, 77 percent of patients failed previous interferon-alfa plus ribavirin therapy and 23 percent failed previous peginterferon plus ribavirin therapy; 64 percent were characterized as nonresponders, 24 percent as relapsers and 12 percent were uncategorized treatment failures.

Overall, 23 percent of retreated patients achieved SVR. Of those who attained a greater than or equal to 2 log decrease in viral load at week 12, 37 percent achieved SVR. Among patients who had undetectable HCV-RNA at week 12, 56 percent achieved SVR. However, only 6 percent of those who attained a 2 log decrease in HCV-RNA but had detectable virus at week 12 achieved SVR. Of this latter group, 17 percent of patients with very low viral load at week 12 (less than or equal to 100 IU) achieved SVR compared to 5 percent of those with residual viral load (greater than 100-250 IU) and no patients with HCV- RNA greater than 750 IU.
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