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Author Topic: First gene therapy to be approved in EU  (Read 2352 times)

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Offline Common_ground

  • Member
  • Posts: 291
First gene therapy to be approved in EU
« on: August 09, 2012, 03:49:31 AM »
Extremely good news! (A few weeks behind I know)
Hopefully this will spur investment and research in gene therapy for HIV as well. Price tag is hefty but nothing strange given the disease and lack of competition. 10 years and GT for HIV on the market?



This is one of the keystones to get to a functional cure. For entities like Sangamo and Bionor this gives a pretty much open road to market products with gene therapy and I bet they celebrated when they heard of this.
Before this approval no gene therapy were available (except China) and has only been done in clinical trials and test tubes.

The approval proves gene therapy is safe and not only a future option to traditional medicine(pills), but already here although only in its cradle.
« Last Edit: August 09, 2012, 06:09:25 AM by Common_ground »
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

2015 CD4: 240 , 28% VL:UD - Triumeq
2015 March CD4: 350 VL: UD

Offline younghopefulpoz

  • Member
  • Posts: 55
Re: First gene therapy to be approved in EU
« Reply #1 on: August 09, 2012, 12:38:22 PM »

Offline Mishma

  • Member
  • Posts: 220
  • HIV drugs are our Allies but hardly our Friends
    • Marquis de Vauban
Re: First gene therapy to be approved in EU
« Reply #2 on: August 09, 2012, 01:44:29 PM »
Thanks for the links!

The statement that "gene therapy is safe," without qualification is simply not true.

The gene therapy trial mentioned in this study was fast tracked under the the orphan medicine act. I am encouraged by the results and hope as well that this success spurs investments in HIV treatment and research. You've correctly remarked that gene therapy is still in it's cradle. Early attempts in the 90's with adeno viruses as vectors were disappointing to say the least.
A good review of the state of the art as it were with respect to the promises of gene therapy and it's problems are in this link.


The authors conclude that despite the myriad of problems associated with gene therapy, they are not insurmountable. 10 years for HIV would be sweet.
2016 CD4 25% UD (less than 20). 30+ years positive. Dolutegravir, Acyclovir, Clonazepam, Lisinopril, Quetiapine, Suatriptan/Naproxen, Restasis, Dorzolamide, Latanoprost, Asprin, Levothyroxine, Restasis, Triamcinolone.

Offline Common_ground

  • Member
  • Posts: 291
Re: First gene therapy to be approved in EU
« Reply #3 on: August 09, 2012, 02:29:55 PM »
I think the "problem" with HIV is current treatment working so well, thus we will never get approval under the orphan act and both EMA and FDA will be more picky to let any dubious treatments through( this also goes for a cure). Risk vs. Benefit.
Never the less the news are suprising and it definately open the doors for research/treatment with GT for a whole host of other diseases.

Impossible to put a timeline on the development, with new "breakthroughs" on a yearly basis we might even abandon GT as treatment option for HIV in the next few years.

Personally I am not a big fan of GT and I dont see it leading to a HIV cure. I believe drug development will eventually get us there with clearing HIV infection by a fixed time on a set of drugs similar to what is done today with many bacterial infections.

2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

2015 CD4: 240 , 28% VL:UD - Triumeq
2015 March CD4: 350 VL: UD


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