Next-generation HCV treatment /July 2010 News Summary

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Next-generation HCV treatment /July 2010 News Summary

Happy Saturday !

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Its the end of the month already folks and now it nears the end of summer. In July a few drugs in current development came out with some promising results ( more on that later).

The good news is that Vertex has started FDA application for " Telaprevir " , now we wait with anticipation on the details of Telaprevir and its two phase III trials which is expected in the next couple of months.

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According to the press the "Illuminate" trial data should be released in August and the "Realize" trial not until September. If you haven't been following the trials with Telaprevir you may want to play catch up with this entry, Telaprevir : An Easy To Understand Review .

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What else was in the news this month ?nl

First drug up is Clemizoleln

In the 1950's Europe and the U.S. used Clemizole to treat skin conditions, namely pruritus and eczema, it was also used for allergic disorders like hay fever. It seems to work well with HCV inhibitors by interfering with the viral replication of the virus. The anti-HCV activity of clemizole is currently being investigated in all genotypes in HCV clinical proof of concept trials along with with standard of care medications

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(HCV) NS4B RNA Binding Inhibitor Clemizole is Highly Synergistic with HCV Protease Inhibitors".

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The government introduced their new web site HealthCare.gov. You may want to check it out and see where you stand.

This to me is sort of ironic Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN , enough said.

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Achillion

Achillion next-generation drug to fight chronic hepatitis C virus . Quote from the article "ACH-1625, a potential next-generation treatment for chronic hepatitis C virus that some investors expect to be the "best-in-class" treatment; ACH-1095, an "NS4A antagonist" also for fighting the hepatitis virus; and ACHN-2684, a molecule that targets NS3 protease found to be effective against a broad range of natural hepatitis variants."

"In the recent IB clinical trials on ACH-1625, safety and tolerability in patients continued to be excellent, notes Kolbert. And the trials also showed "meaningful reductions in the key pharma paradigm for antiviral therapy,"

Ponder this folks... "Telaprevir requires twice-a-day dosing, he notes, while ACH-1625 needs only once-daily dosing."

This Is Exciting News ......

,TMC435 is a protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals.

Medivir Announces Phase 2b 24-week Interim Results of TMC435 in Treatment-naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus

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The three phase 2b current trials are as follows ......

First The Pillar Study (Geno 1 never treated)

TMC435-C205-(or the PILLAR study, is a global phase 2b study in 386 genotype-1 treatment-naïve patients)

TMC435-C205 is a global phase 2b study in 386 genotype-1 treatment-naïve patients. It is a once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

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Next TMC435-C206 ( Geno 1 Patients Treated Before)

This study has 463 genotype-1 treatment-experienced patients. It is a once daily treatment of TMC435 in with different doses of given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

And finally TMC435-C215 ( Geno 1 Never Treated Before)

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TMC435-C215 is a Japan phase 2b study in 92 genotype-1 treatment-naïve patients. It is a once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A. Genotype 1 patients that failed previous IFN-based treatment.

Now on with the PILLAR study results.........

Quoted from Source

In TMC435 is an investigational protease inhibitor, administered one pill a day, developed by Ireland-based company Tibotec Pharmaceuticals Ltd in collaboration with Medivir.l

The so-called Pillar trial is a global double-blind, placebo-controlled Phase IIb study, in which 75 mg or 150 mg of TMC435 was administered for either 12 weeks or 24 weeks in addition to 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). The trial included 386 treatment-naive patients.

lBased on meeting certain response-guided criteria, a total 83% of the patients in the TMC435 treatment groups were able to stop all therapy at week 24.

l"Potent and consistent antiviral efficacy was demonstrated at 24-week end-of-treatment and in interim SVR4 and SVR12 rates with no major differences between TMC435 doses or length of triple therapy," Medivir said.

lThe results also showed that candidate drug was generally safe and well tolerated with no relevant differences in adverse events compared with placebo.

lFurther safety and efficacy data from the Pillar trail will be presented at scientific meetings later this year.

lBy the end of 2010, Medivir expects to report top-line results from another global Phase IIb study, so-called Aspire, testing TMC435 in addition to SoC in 463 treatment-experienced patients with HCV genotype-1.

lThe Swedish company also plans to start Phase III clinical trials in treatment-naive patients early next year, CEO Bertil sson said. .,.

continue reading

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Here are a few other important developments in HCV/HIV for the month of July

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Video/HIV Microbicide Gel

FDA Approves First Rapid Hepatitis C Virus Antibody Blood Test

Phase 2 Trial Of SCV-07 In Hepatitis C/ SciClone

CF102 To Treat Liver Cancer Phase I/II trials

Milk Thistle/The Study 2010

..A popular article this month was from the New York Times written by ANDREW POLLACK titled Hope Against Hepatitis C.

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The new highlights from ANA598 were released with the results of the Phase II study.

Recent ANA598 Highlights from Phase II Combination Study

This is the deal six of six patients or (100%) in the study with ANA598 dosed at 200 mg twice daily (bid) arm who were randomized to stop all treatment at Week 24 in an ongoing Phase II trial maintained undetectable 12 weeks after stopping treatment, referred to as "Sustained Virological Response 12" or the buzz word...."SVR12."

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The highlights went on to show that patients from the ANA598 dosing at the 200 mg arm who previously reported to have cleared the virus at Week 24 and continued on with pegylated interferon and ribavirin and also maintained undetectable at Week 36. Shut me up right now !

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But there's more folks, all patients from the ANA598 who dosed at the 400 mg in the trial who were previously had cleared the virus or undetectable at week 12 and continued on with peg/riba or "SOC" were still undetectable at Week 24. Whew !

Response-guided treatment is an important element in these trials , we saw it in six patients who stopped all treatment at week 24.

For anyone who is new to treatment reading this entry will help you to understand what this means , and how important it is in your treatment regimen.

Check it out.........HCV New and Old Therapies

PSI-352938 ("PSI-938")

Trial of PSI-938 in Patients with Chronic Hepatitis C

PSI-938 Phase 1The Phase 1 program is all about the safety, tolerability and pharmacokinetics (Pharmacokinetics is the study of what the body does to a drug) of PSI-938 in healthy subjects following escalating single doses

(Phase 1a), is with HCV genotype 1 following repeat dosing for "7 days (Phase 1b)."

The Phase 1b study investigates hepatitis C viral dynamics and monitor for the development of drug resistance.

kSubjects in the Phase 1a single ascending dose study received single doses of PSI-938 ranging from 100 mg to 800 mg or a matching placebo.

Preliminary data from the phase 1a single ascending dose study includes: -- No serious adverse events or discontinuations;

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-- No dose-related adverse events or dose-limiting toxicity;-- No grade III / IV lab abnormalities;-- No clinically significant changes in vital signs or ECGs; and-- PK=pharmacokinetics which supports QD dosing.

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A Phase 1b multiple ascending dose trial has now been initiated in treatment-naïve patients with chronic HCV genotype 1 infection.,

According to the press release........"Subjects will be enrolled at multiple centers in the US and randomized to PSI-938 or placebo. Based upon the results from the first time in human study, the first dose of PSI-938 to be tested will be 100 mg administered once daily. The primary objectives of this study are to assess the safety, tolerability, pharmacokinetics and viral dynamics of PSI-938 after repeat dosing over 7 days."

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Results from both studies are expected in the third quarter of 2010.

Have a great weekend !

http://Hepatitis Cnewdrugs.blogspot.com/2010/07/next-generation-hcv-treatment-july-2010.html