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Hep C Discussion Forum -> General Discussion -> Benitec One Shot TX
Post Info TOPIC: Benitec One Shot TX
Loopy Lisa


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RE: Benitec One Shot TX
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That is because it is at phase 1 in human trials, I doubt anyone would consider costs at this stage....



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
jimbob


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If it is successful, I don't think I've read anything or even seen it mentioned about the cost of this 1 shot cure. Anyone?

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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.
Loopy Lisa


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If this pans out well, it will be the future of Hep C treatment. I would be the last in line for the first in human trials, but I will follow with interest. It seems medicine is moving forward at an extreme rate, I hope the same occurs for other diseases. We are unlucky to be infected, but we are lucky there are options in the future. It sure does sound appealing 1 injection and done!



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
Isiscat2011


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Tig56 wrote:

Best of luck for those brave souls willing to pioneer such a risk laden opportunity. Of course with any of these medications, FDA approval or not, the long term implications will take years and maybe decades to fully present themselves. The continuing negative SFX of Interferon are one example of the unknown and it has been around for decades. I'll say a prayer for their bravery and success.

Tig

My heart goes out to them.  The phase 1s are usually the healthiest people afflicted with the disease, but sadly, they are often the most desperate for tx due to lack of access to tx drugs.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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jimbob wrote:

Thanx for posting that Isis.

And yes Isis, I know I'm one.... 



-- Edited by jimbob on Friday 30th of May 2014 05:21:26 PM

 Takes one to know one!  I have to laugh at myself sometimes when I find myself combing through the data like some mad scientist.  biggrin



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Zlikster


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Any trials for GT3? ;) not sure i would be brave enough for Phase I, but for Phase II and III i would be first in the line ;)

 



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
jimbob


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Thanx for posting that Isis.

And yes Isis, I know I'm one.... 



-- Edited by jimbob on Friday 30th of May 2014 05:21:26 PM

__________________

jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.
Tig


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Might be time to consider investing in Benitec. Currently $1.02/share on the AUS exchange. Gilead is now $81.00 on the US exchanges and I hear talk of a split. If Benitec succeeds, now is the time to buy!

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Tig


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Best of luck for those brave souls willing to pioneer such a risk laden opportunity. Of course with any of these medications, FDA approval or not, the long term implications will take years and maybe decades to fully present themselves. The continuing negative SFX of Interferon are one example of the unknown and it has been around for decades. I'll say a prayer for their bravery and success.

Tig



__________________

Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 
Isiscat2011


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And, here are the intimate details of the clinical trial for all the Type A, Anal-Retentives, out there (yes, you know who you are):

 

About the TT-034 Phase I/IIa Clinical Trial

The TT-034 Phase I/IIa clinical trial is an open label, single dose, dose escalation study in 14 patients infected with genotype 1 hepatitis C virus (HCV.) The trial is comprised of five dose cohorts, organised as follows:

 
                                                                  Observation 
                                                                  period per 
                                                                  Patient and 
                       Dose                                       between 
                       escalation                                 cohorts 
                       step (log       Number of    Dosing        before dose 
Cohort  Dose (vg/kg)   10)             Patients     scheme        escalation 
------  -------------  ------------  -------------  ------------  ------------ 
                         Starting                   Sequential 
1       4.00 x 10(10)      dose            2        (1+1)         6 weeks 
        -------------  ------------  -------------  ------------  ------------ 
                                                    Sequential 
                                                    and parallel 
2       1.25 x 10(11)      0.5             3        (1+2)         6 weeks 
        -------------  ------------  -------------  ------------  ------------ 
                                                    Sequential 
                                                    and parallel 
3       4.00 x 10(11)      0.5             3        (1+2)         6 weeks 
        -------------  ------------  -------------  ------------  ------------ 
                                                    Sequential 
                                                    and parallel 
4       1.25 x 10(12)      0.5             3        (1+2)         10 weeks 
        -------------  ------------  -------------  ------------  ------------ 
                                                    Sequential 
                                                    and parallel 
5       4.00 x 10(12)      0.5             3        (1+2)         10 weeks 
------  -------------  ------------  -------------  ------------  ------------ 
 
   -- Independent Data Safety Monitoring Board review after first patient in 
      each cohort and between cohorts 
 
   -- Extensive safety monitoring during 24 weeks of observation

Trial sites:

   -- Duke Clinical Research Unit, North Carolina (Dr. Keyur Patel) 
 
   -- University of California, San Diego (Dr. David Wyles)

Primary endpoints: safety

   -- Incidence of treatment-emergent adverse events 
 
   -- Changes in clinical and laboratory parameters

Secondary endpoints: efficacy

   -- Sustained reduction in HCV viral load 
 
   -- Assessment of viral vector DNA levels in liver biopsy 
 
   -- Assessment of shRNA expression in liver biopsy 
 
   -- shRNA expression levels in exosomes in serum 
 
   -- Blood vector DNA levels in serum

About Benitec Biopharma Limited:

Benitec Biopharma Limited is an ASX-listed biotechnology company (ASX Code: BLT) based in Sydney, Australia. The company has a pipeline of in-house and partnered therapeutic programs based on its patented gene-silencing technology, ddRNAi. Benitec is developing treatments for chronic and life-threatening human conditions such as Hepatitis C, Hepatitis B, wet age-related macular degeneration, cancer-associated pain, drug resistant lung cancer and oculopharyngeal muscular dystrophy based on this technology. In addition, Benitec has licensed ddRNAi technology to other biopharmaceutical companies who are progressing their programs towards the clinic for applications including HIV/AIDS, retinitis pigmentosa and Huntington's disease. For more information on Benitec refer to the Company's website at www.benitec.com.

SOURCE Benitec Biopharma Limited

/Web site: http://www.benitec.com



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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 Benitec just dosed its first human with the one shot treatment.  This article was in the Wall Street Journal today:

SYDNEY, May 29, 2014 /PRNewswire/ -- RNAi-based therapeutics company, Benitec Biopharma Limited (ASX: BLT) is pleased to announce that it has dosed the first patient in its 'first in man', Phase I/IIa clinical trial for TT-034, a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single injection.

Benitec Biopharma's CEO and Managing Director, Peter French said, "The commencement of this clinical trial of TT-034 represents a landmark in the Company's history. The trial is the first time Benitec's gene silencing technology, ddRNAi, has been used systemically in patients.

The primary objective of this first trial is to demonstrate that TT-034 can be used safely in patients with HCV. Preclinical work in non-human primates demonstrated very low toxicity results at therapeutically relevant doses, and we're hopeful that we will see the same favourable tolerability in humans. In addition, we will be able to assess the impact of TT-034 treatment on HCV viral load in these patients, and this important efficacy marker constitutes one of the secondary endpoints of this study."

The TT-034 Phase I/IIa clinical trial is an open label, dose escalation study in a total of 14 patients chronically infected with HCV genotype 1. Initial patient cohorts will be treated with a sub-therapeutic dose of TT-034 to ensure that there are no unexpected safety concerns, before proceeding to higher, potentially therapeutic doses.

An expert medical panel, the Data Safety Monitoring Board (DSMB), which is independent of Benitec, will carefully assess the data from each patient, in particular the safety data. The DSMB assessment will occur after the first patient in each cohort and between cohorts, and will determine the timing of each subsequent dosing.

Additional detail on the clinical trial design and protocol is included at the bottom of this announcement.

For further information, please contact the persons below, or visit the Benitec website at www.benitec.com.

 


__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
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