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Author Topic: Vacc-4x trials to begin in Germany  (Read 3585 times)

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Offline Common_ground

  • Member
  • Posts: 288
Vacc-4x trials to begin in Germany
« on: August 14, 2012, 11:16:50 AM »
Norwegian Bionor teams up with German Celgene - receives approval for clinical trials in Germany.

Seems like they will use a cancer drug together with the Vacc-4x to reduce (eradicate?) the latent virus population and at the same time increase healthy CD4 cells.

http://www.bionorimmuno.com/en/News_archive/2012/All/Study+of+Vacc-4x+Combined+with+Celgene%60s+Revlimid%C2%AE+Approved+to+Begin.b7C_wlnU3g.ips

http://finance.yahoo.com/news/study-vacc-4x-combined-celgenes-115900755.html
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

Offline buginme2

  • Member
  • Posts: 2,834
Re: Vacc-4x trials to begin in Germany
« Reply #1 on: August 14, 2012, 11:33:54 AM »
Norwegian Bionor teams up with German Celgene - receives approval for clinical trials in Germany.

Seems like they will use a cancer drug together with the Vacc-4x to reduce (eradicate?) the latent virus population and at the same time increase healthy CD4 cells.

http://www.bionorimmuno.com/en/News_archive/2012/All/Study+of+Vacc-4x+Combined+with+Celgene%60s+Revlimid%C2%AE+Approved+to+Begin.b7C_wlnU3g.ips

http://finance.yahoo.com/news/study-vacc-4x-combined-celgenes-115900755.html

This study is not looking a or testing eradication of latent HIV.   They are seeing if they can improve immune response in people who have achieved an undetectable viral load but have had a poor cd4 recovery.

Offline Common_ground

  • Member
  • Posts: 288
Re: Vacc-4x trials to begin in Germany
« Reply #2 on: August 14, 2012, 11:53:49 AM »
"a secondary endpoint of the study is also to evaluate the effect on HIV viral load, by sensitive analysis methods."

I took this part as a sign of how to reduce latent/virus producing cells or lower the viral "setpoint". I might be reading too much into the press release thou but given they use a cancer drug the procedure seems awfully inspired by recent research of flushing latent HIV.
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

Offline Matts

  • Member
  • Posts: 206
Re: Vacc-4x trials to begin in Germany
« Reply #3 on: August 20, 2012, 05:33:57 PM »
As i read Vacc-4-x had some good results in Hamburg, but not a breakthrough.
Maybe the follower Vacc-C5 will work even better.

http://www.bionorimmuno.com/en/Vaccines/HIV_Vacc-C5/
tivicay/kivexa

Offline elf

  • Member
  • Posts: 596
Re: Vacc-4x trials to begin in Germany
« Reply #4 on: August 21, 2012, 06:03:49 PM »
Why can't they combine it with Miltefosine?  :o

http://en.wikipedia.org/wiki/Miltefosine
Quote
Miltefosine (INN, trade names Impavido and Miltex) is a phospholipid drug.

Originally developed as an antineoplastic (and licenced for topical use),[2] it is finding use as an antiprotozoal drug. It can be administered orally and topically.

It acts as an Akt inhibitor.

It is also under investigation as a potential therapy against HIV infection.[3][2]

Miltefosine targets HIV infected macrophages, which play a role in vivo as long-lived HIV-1 reservoirs. The HIV protein Tat activates pro-survival PI3K/Akt pathway in primary human macrophages. Miltefosine acts by inhibiting the PI3K/Akt pathway, thus removing the infected macrophages from circulation, without affecting healthy cells.[2]
Let's have a Kiki!

Offline Dr.Strangelove

  • Member
  • Posts: 206
Re: Vacc-4x trials to begin in Germany
« Reply #5 on: August 25, 2012, 03:36:41 AM »
Hmm, I have been pretty optimistic about this vaccination approach.

But the preliminary results here
http://www.catie.ca/en/catienews/2012-02-21/norwegian-hiv-vaccine-very-modest-results-seen-recent-clinical-trial
don't sound like a break through.
Perhaps the combination of Vacc-4x and Vacc-5x will bring some more promising results?

Offline Newguy

  • Member
  • Posts: 127
Re: Vacc-4x trials to begin in Germany
« Reply #6 on: August 25, 2012, 08:33:12 AM »
Dr Strangelove the article that you reference contradicts this one"

http://www.4-traders.com/BIONOR-PHARMA-ASA-1413224/news/Bionor-Pharma-ASA-Results-for-viral-load-on-Vacc-4x-14023683/

More specifically, in the CATIE article the author writes:  "Whatever impact Vacc-4x had on viral load, it did not allow recipients to remain off therapy longer than people on placebo."

However in the link I posted, the article states "These final results confirm that Vacc-4x lowers viral load in patients with HIV who have remained off ART for at least 6 months," said Vidar Wendel-Hansen, MD, PhD, Chief Medical Officer, Bionor Pharma, "and suggests a correlation between this effect and the vaccine induced immune responses to p24."

Whatever you make of it there it is. I also read somewhere some people were off ART for two years after receiving Vacc-4X.

Best

Offline Common_ground

  • Member
  • Posts: 288
Re: Vacc-4x trials to begin in Germany
« Reply #7 on: August 25, 2012, 09:18:54 AM »
In the 2012 Q2 report Bionor mention they have initiated the process of partnership with a larger pharma for phase III development AND commercialization. I think its clear already the method is working but there is alot more work to be done, my point is that they wouldnt pushed for further development and make a bold statement like that with a product not worthy continous investment and work.
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

Offline Jmarksto

  • Member
  • Posts: 469
Re: Vacc-4x trials to begin in Germany
« Reply #8 on: August 25, 2012, 11:26:26 AM »
In the 2012 Q2 report Bionor mention they have initiated the process of partnership with a larger pharma for phase III development AND commercialization.

My read on this is that Bionor is securing funding through a larger pharma partner prior to the completion (or even the start) of the phase II trial, so they are ready from a business perspective in the event the trials are promising.  I think this is more of a statement about their business strategy than the science.  Of course I would like to see the science pan out, but we have to wait for the data.

JM

03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline Common_ground

  • Member
  • Posts: 288
Re: Vacc-4x trials to begin in Germany
« Reply #9 on: August 25, 2012, 12:20:02 PM »
Phase IIb trials are already running and have been for quite some time. The results from 136 patients were released earlier this year:

http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5513

The Q2 report can be found here:

http://www.bionorimmuno.com/filestore/Q2_2012Report.pdf

Im hoping for some more data and good news from the conference in Boston next month.
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

Offline Jmarksto

  • Member
  • Posts: 469
Re: Vacc-4x trials to begin in Germany
« Reply #10 on: August 25, 2012, 01:26:17 PM »
I was referring to the trial just approved that combines Vacc-4x with Celgene`s Revlimid:

http://tinyurl.com/8nlkhqm

On a related but different topic - Sangamo is presenting on their ZFN CCR5 work in early September:

http://tinyurl.com/8krre36
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD
07/09/14 CD4 1004/39%   VL UD

Offline Dr.Strangelove

  • Member
  • Posts: 206
Re: Vacc-4x trials to begin in Germany
« Reply #11 on: August 25, 2012, 06:54:02 PM »
Thanks for the clarification and all the updates.
This sounds indeed very promising!

 


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