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Post Info TOPIC: Something NEW in HCV News
mallani


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RE: Something NEW in HCV News
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Hi Brownie,

This will be a very long process. As Benitec is Australian, I have been following their progress for the last 18 months.

With the Phase 1-2 Trials, they are trying to find the optimal dose of TT-034. There are 5 dosing cohorts, with 3 for 6 weeks and 2 for 10 weeks. The first patient in each cohort must finish the course and have a liver biopsy before the next patient is started. The selection criteria for patients is very rigid.

It will take a year before we get sufficient information to see whether this really is a treatment option. At the moment, I'm not sure it will be. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
Miss B


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This is potentially a miracle cure. I applied for this study but was turned down because I had not gone through menopause & they didn't want there to be any possibility of pregnancy. As Matt noted,

those who get the one shot have to live with a long term ramifications which could be good or bad.

 



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Miss B
56 years old. Genotype 1B, previous treatment with interferon 1994. Started Harvoni 12/8/14. After 2 weeks, VL dropped from over 4 million to 496. At 4 weeks, undetected, but at 8 weeks, <15 mL (detected), at 12 weeks/EOT UND!  
Brownie


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I found it odd to have a clinical trial with just a few people, but wouldn't it be wonderful to have a single shot that cures and potentially prevents future infections? Wow!



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Matt Chris


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Hey Brownie

Thanks for the post, have been watching this company for about a year and they are moving very slowly with their Phase 1 and Phase 2. I believe that the reason is once the drug is induced in the body it is not eliminated like a normal drug. It stays in the body and alters the RNA on a semi permanent basic, so those who get the one shot have to live with a long term ramifications which could be good or bad. The trials should reveal any obvious issues, but the very small amount of patients enrolled shows that Benitec is very, very cautious. This will likely take a long time to get FDA approval at this pace.

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Brownie


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Benitec Advances Hepatitis C Clinical Trial

SYDNEY, Jan. 7, 2015 /PRNewswire/ -- Benitec Biopharma Limited (ASX: BLT, OTC: BTEBY) is pleased to advise that the third patient in its Phase I/IIa clinical trial of TT-034 for hepatitis C was dosed earlier today at the Duke Clinical Research Unit (USA). This is a significant step for this "first in man" study, and follows review of the collective data from the first two patients by the independent Data Safety Monitoring Board (DSMB). The DSMB determined that the patients from the first dosing cohort were clear of any significant treatment-related adverse events.

The newly dosed patient is the first to receive the increased dose of TT-034 (1.25 x 10^11 vg/kg, a concentration that is a half log higher than the doses administered in the first cohort). While TT-034 is designed as a potential "one-shot" cure for hepatitis C, the current dose is still below that expected to inhibit viral replication and data from the second dosing cohort are therefore expected to serve primarily as a further safety assessment.

As with previous patients, the newly dosed patient will be monitored for six weeks and results will be reviewed by the DSMB. Should the results indicate appropriate safety outcomes, the DSMB is expected to recommend that the remaining two patients in the second cohort be dosed. It is aimed to dose both at approximately the same time. The trial sites at Duke Clinical Research Unit and University of California San Diego have identified a number of patients who have passed initial screening who can be prepared in anticipation of this outcome.

About TT-034

TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a "triple therapy" even though it is a monotherapy, and minimizes the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells, it enters the nucleus and produces three separate short hairpin RNAs continuously for the lifetime of the cell. Thus TT-034 has the potential to not only treat the existing HCV infection, but also to guard against reinfection for months to years without the need to re-treat. TT-034 safety and efficacy has been tested extensively in pre-clinical in vivo studies with no adverse effects observed at therapeutic doses.



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