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Author Topic: Calimmune: Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-  (Read 22417 times)

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Offline Hoyland

  • Member
  • Posts: 52
Hi dico, sorry to hear that Prof Berkhout has not replied to you. I have no reason to contact him personally and so I really cannot assist any further. Here is his email address, in case you have been using a different one b.berkhout@amc.uva.nl

Offline dico

  • Member
  • Posts: 44
I emailed him again :)

Do you know more about the way Prof Berkhout plans to eradicate hiv from the body  ? I know it is a gene therapy aiming to keep the HIV proviral silent inside cells. But I've never seen any scientific paper about this approach. And I am quite dubious about this way as we do not know where the HIV hides... I am sceptical.

Thank you.


Offline dico

  • Member
  • Posts: 44
My email to Prof Berkhout :

Hi Prof. Berkhout,

I just wanted to know if you still plan to begin your clinical trial of hiv gene therapy ? I am a French hiv positive man interested by your research.

The American are conducting since last year a gene therapy thanks to Calimmune and Benitech technology. Unfortunately they don't plan to have a trial here in France. What about you ? How can we be more informed about your research ?

Thanks a lot.

Julian

Envoyé à partir de mon smartphone Sony Xperia™



Prof Berkhout answered :

Dear Julian,
Pre-clinical research is moving slowly forward, in part because of limited funding. Thus, we are there yet. Thank you for inquiring.
All the best,
Ben Berkhout


Unfortunately he gave no date for the clinical trial...

Offline dico

  • Member
  • Posts: 44
Latest updated: (delay)

"We are still trying to fill cohort 1. We have a waiting list for all of the other cohorts that include chemo, but its been really hard trying to fill the non-chemo arm. We currently have a few guys lined up to screen for the last spot and hopefully one would qualify. Because of the delay, all of the other cohorts must be pushed back as well. We will not know if any of the three qualifies until the end of December/early Jan. If that is the case, we would not be expecting to start the next cohort, small dose of chemo, until probably Feb/March. You are still in the forefront!"

So JazJon did you hear some good news about the cohort 1?

Offline JazJon

  • Member
  • Posts: 94
So JazJon did you hear some good news about the cohort 1?

Nothing yet but I was called back to participate a second time in the Gilead HIV Latency Study​​ again.  (3 hour apheresis)  I'll ask for an update on Calimmune.

Offline dico

  • Member
  • Posts: 44
Nothing yet but I was called back to participate a second time in the Gilead HIV Latency Study​​ again.  (3 hour apheresis)  I'll ask for an update on Calimmune.

Thanks.

What is this study ? They take blood from you and that's all ? Fo what purpose ?

Offline JazJon

  • Member
  • Posts: 94
Thanks.

What is this study ? They take blood from you and that's all ? Fo what purpose ?

http://www.questclinical.com/#!studies/cjg9
(Scroll down)

Offline dico

  • Member
  • Posts: 44
Unfortunately, there were no news of the calimmune trial at CROI 2014.

Anybody here has new information ?

Offline JazJon

  • Member
  • Posts: 94
Update.   Looks like I'm on stand by for cohort 3.  Here's a summary of what else I learned.

- San Francisco finally filled the last slot in cohort one and are starting to bring people in for cohort 2 (low dose chemo)

- They are currently 8 months behind schedule because of the unexpectedly high screen fail rate.  One of the reasons, or 'problems', with why it took so long to fill the first cohort is because the FDA did not allow them to screen more than one patient at a time!! Which is at least a 6 week process per patient!

-  They have recently changed the protocol to allow them to screen 4 patients at once, so hopefully that will help expedite cohort 2's screening.

Offline dico

  • Member
  • Posts: 44
Great news.

There's a chance you can get ''cured'' with this medium busulfan dose. It would have been better if they'd give you an immunotoxin and a therapeutic vaccine with it but do not forget that it is only a phase I study.

I hope you'll begin this year. I have great hope for the cohort 3 people.

Imagine what a great combination would be this ddRNAi gene therapy coupled with an antibody vaccine (such as the VIP of David Baltimore encoding the PG09/PG16/PG121 antibodies) boosted with a Tcell vaccine (CMV vaccine of Louis Picker) and the dual TLR7 agonist/romidepsin therapy being investigated by Gilead.

Romas Geleziunas of Gilead has made a speach in CROI 2014: they think an activating agent such as an improved romidepsin with a TLR7 agonist taken with intensified ART (Stribild+maraviroc) could lead to a cure. He told the audiance that these drugs could be taken for one to three months, then a prime antibody vaccine boosted with a T cell vaccine could keep the HIV under control for a lifetime.

Offline dico

  • Member
  • Posts: 44
I received an email : the first patient of the cohort 2 will begin his theray within 2 weeks.

They have enrolled all of the cohort 2 and people are queueing to be part of the cohort 3.

Offline Seanl

  • member
  • Posts: 1
Is anyone on this forum part of the first cohort for callimune?
Id love to IM you and pick your brains...

Offline dico

  • Member
  • Posts: 44
I would also be interested to know how was the whole process? Do you know your VL and CD4?
.thanks

Offline Cosmicdancer

  • Member
  • Posts: 138
Do you know how many people are in each cohort?  The link I saw to the clinical trial didn't say.
Summer, 2007 - &$#@?
November, 2007 - Tested poz, 300,000 vl, 560 cd4
Feb, 2008 - 57,000 vl, 520 cd4, started Atripla
June, 2008 - undetectable, 612 cd4
January, 2009 - undetectable, 670 cd4
May, 2009 - undetectable, 593 cd4
Sept, 2009 - 83 vl, 763 cd4, 34%
Dec, 2009 - undetectable, 889 cd4, 32%
April, 2010 - undetectable, 860 cd4, 31%
October, 2010 - undetectable, 800 cd4, 38%
April, 2011 - undetectable, t-cell test not done
October, 2011 - undetectable
April, 2012 - undetectable, 850 cd4, 39%
November, 2012 - undetectable, 901 cd4, 41%
April, 2013 - undetectable, 846 cd4, 36%
October, 2013 - undetectable

Offline dico

  • Member
  • Posts: 44
It s a very small trial. Only 4 in each cohort

Offline Hoyland

  • Member
  • Posts: 52
Calimmune's collaborator, UCLA, published some new pre-clinical data. UCLA has tracked the long term viability of CCR5 shrna modified HSPCs (blood stem cells) in non-human primates. This is important work as it models the Cal-1 treatment for HIV that Calimmume is currently trialling in patients.

The study showed that about half of the clones contributed to long term (3-10 years)  repopulation. While this is extremely exciting in terms of Cal-1 potential as a long term cure for HIV, it still remains to be seen if sufficient HSPC's can be transfected in the first place in order to provide patients with a viable population to overcome the HIV.

http://www.sciencedirect.com/science/article/pii/S1934590913005614

Dr Chen, a co-author, is on Calimmune's Scientific Advisory Board.

 


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