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Author Topic: Calimmune: Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-  (Read 31374 times)

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Offline Tadeys

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I remember reading on this forum a couple of months ago how scientist have discovered that they could DIRECTLY engraft cells with zinc fingers--- meaning, pour zinc fingers over cells. The cells studied endocytized the zinc fingers. This lead to a higher engrafment percentage then using the freaking adenovirus vector. But don't know if Callimine's technology can allow that "pouring"; besides, Calimunne is trying to delete a gene---like Sangamo-- AND insert an anti HIV gene....so, I think they need a the damn vector.

 There is Proof-of-principle that these anti HIV techniques CAN work...scientist just have to tweak them. Some newer anti HIV gene therapy technologies--still preclinical--seem light years ahead of the technology Sangamo, CoH, or Callimune have.

Online geobee

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Carlos Barbas et al are doing "naked" ZFNs at the Scripps Institute in San Diego.  No vector.

http://www.genengnews.com/gen-news-highlights/naked-zfns-point-to-more-efficient-safer-gene-therapy/81246989/

Offline Hoyland

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For those interested Calimmune's CEO and CSO will be giving a talk on Thursday at noon explaining their work with stem cells and HIV. The talk will be webcast.

http://www.cirm.ca.gov/agendas/05202013/spotlight-hiv-immunity-pathway-clinical-trial?utm_source=twitterfeed&utm_medium=twitter

Offline JazJon

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For those interested Calimmune's CEO and CSO will be giving a talk on Thursday at noon explaining their work with stem cells and HIV. The talk will be webcast.

http://www.cirm.ca.gov/agendas/05202013/spotlight-hiv-immunity-pathway-clinical-trial?utm_source=twitterfeed&utm_medium=twitter

Interesting, I hope we can listen to it later in the day if we miss the live stream.

Offline JazJon

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For those interested Calimmune's CEO and CSO will be giving a talk on Thursday at noon explaining their work with stem cells and HIV. The talk will be webcast.

http://www.cirm.ca.gov/agendas/05202013/spotlight-hiv-immunity-pathway-clinical-trial?utm_source=twitterfeed&utm_medium=twitter

I missed it, I don't see any replay streaming options.   Did anyone catch it?  Did they share any interesting new information?

Offline Jmarksto

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I missed it, I don't see any replay streaming options.   Did anyone catch it?  Did they share any interesting new information?

Jaz; it is scheduled for Thursday (if I read Hoyl's post correctly), and it is still Wednesday so I don't think you have missed it.
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 JazJon

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Jaz; it is scheduled for Thursday (if I read Hoyl's post correctly), and it is still Wednesday so I don't think you have missed it.

Oh whoops! lol

Offline Tadeys

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Can't see the presentation vía my f$&/@ing iPad. Can somebody comment on the presentation. Thanks. :)

Offline JazJon

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Well if they said anything interesting, it must have been in the beginning.   

I missed the first 30 minutes.   When I finally joined in, I only heard them voting down funding some unrelated bone stimulation thing.  (and then they broke for lunch)   

I tried again much later and all I heard was several good bye speeches to someone moving on.

So yeah someone will have to fill us in if anything interesting was talked about related to the Calimmune Study specifically.

Offline Hoyland

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The technology conspired against me and I too missed the presentation. However, the CIRM is shortly going to post a video online and so those that want to see the whole thing will be able to do so.

Offline Hoyland

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Hi SFGMOMO,

Based on your last post you should have had your second apheresis by now and possibly your treatment. How are things progressing, or have you had to sign a non-disclosure agreement and so are not in a position to tell us?

Offline JazJon

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"HIV Trial to Create New Immune Systems"
Tue, 2013-06-18

http://www.biosciencetechnology.com/articles/2013/06/hiv-trial-create-new-immune-systems#.UcI60PnbPL-

"Some preliminary results have been highly encouraging"


Offline Hoyland

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Looks like those on the trial will start dosing in July. Good luck to you all. :)

Offline Hoyland

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First Patient Treated in Clinical Trial Testing an Innovative Stem Cell Treatment for HIV/AIDS

San Francisco, CA – Calimmune has treated the first patient in a clinical trial involving the use of an innovative gene-based stem cell therapy to help protect individuals infected with HIV from the effects of the AIDS virus.

The Phase I/II clinical trial - which California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM) is helping fund - focuses on a protein called CCR5 that plays a critical role in enabling HIV to infect cells. Blocking CCR5 may provide the cells a protective shield against HIV, which in turn would help retain immune system functionality

In this study 12 HIV-positive individuals will be infused with their own blood stem cells that carry a gene that has been modified to block production of CCR5. The hope is that those stem cells will then create a new blood system that is resistant to HIV. To guard against the virus forming resistance, the team has used a second mechanism to prevent the virus from fusing with the patient’s cells.

“This study is an early but important step in an emerging area of scientific exploration, representing the culmination of more than a decade of research and development,” says Calimmune Chief Executive Officer Louis Breton.  “We are optimistic that what we learn from this study may bring us closer to the day when a one-time or infrequent treatment could lessen, delay or provide an alternative to a lifetime of antiretroviral therapy.”

The goal of the trial – which is being conducted in San Francisco and Los Angeles - is to assess the safety of the therapy, to determine the ease of use and feasibility of the approach for HIV/AIDS patients and to evaluate what, if any, side effects there may be.

“CIRM funding of this Phase l/ll trial is an important milestone for us,” says Alan Trounson, PhD, President of the stem cell agency. “One of our goals is to support research that moves the most promising science out of the lab and into clinical trials in people. To be able to do that with a disease as devastating as HIV/AIDS highlights the importance of our funding and the potential impact it could have on the health of people around the world.”

Jeff Sheehy, the Patient Advocate member of our governing Board for HIV/AIDS, and a longtime community activist, says regardless of the results the trial is important:

"This trial will hopefully offer several important insights into the safety and feasibility of genetically modifying blood forming stem cells in an HIV patient as a potential therapy.  We are very early in this research, and with this Phase I trial's goal of establishing safety and the risks involved, I applaud the courage and altruism demonstrated by the patients who are willing to participate in this study."

According to the Centers for Disease Control and Infection (CDC) more than 1.2 million people in the US are living with HIV. This number is growing because new and more effective medications are keeping people alive longer with the infection. However, these medications – which have to be taken every day - are expensive and, over time, have side effects.
For more information about this trial, visit www.clinicaltrials.gov

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.

About Calimmune
Calimmune is a clinical-stage HIV gene medicines company focused on developing innovative cell-based therapies for HIV.  The company’s stem cell technology was discovered in the labs of Nobel Laureate, Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute).  Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

Offline 1in1000000

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Can someone explain  with more details how protein (C46) inhibits HIV?
It is on the surface of the cell or inside?
« Last Edit: July 10, 2013, 08:03:45 PM by 1in1000000 »

Offline Matts

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...."As mentioned above, only a fraction of cells will acquire mutations at both alleles of CCR5 following genetic targeting. By combining this gene therapy approach with pharmacological approaches, antagonism of HIV entry may be further enhanced. For example, peptides such as C46 and T20/enfuvirtide act as dominant negatives to block membrane fusion.CCR5 binding small molecules, such as INCB9471, Vicriviroc, Aplaviroc and, most notably, Maraviroc, block association with env and are predicted to phenocopy CCR5 genetic disruption...."

http://www.nature.com/gt/journal/v20/n7/full/gt201298a.html


"Calimmune’s ddRNAi-based HIV candidate LVsh5/C46 for example down-regulates the cellular receptor for viral entry, CCR5, such that HIV particles cannot enter cells and integrate into their genomes in the first place.  As an ddRNAi gene therapy approach, LVsh5/C46 further takes advantage of the fact that you can express a therapeutic protein along with the RNAi trigger, thus uniquely combining mechanisms of actions in a single drug...."

http://rnaitherapeutics.blogspot.de/2012/12/viruses-beware-this-time-rnai.html

tivicay/kivexa

Offline Hoyland

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This latest profile of Calimmune may be of interest to some who could not seem themselves as qualifying for the treatment currently being trial by the company. See the sentence in bold:

Quote
Calimmune is a clinical-stage HIV gene medicines company focused on developing innovative cell-based therapies for HIV. The company’s stem cell technology was discovered in the labs of Nobel Laureate Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute). Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

Offline Hoyland

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Video of Calimmune presentation to CIRM.

http://www.youtube.com/watch?v=d5GSJeaAgP0

Offline freewillie99

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Video of Calimmune presentation to CIRM.

http://www.youtube.com/watch?v=d5GSJeaAgP0

Good video, as is the second featuring Dr. Geoff Symonds, Calimmune's Chief Scientific Officer.  The quiet confidence both bring to their presentations (vs. more typical corporate bravado and hyperbole) gives me hope.  Also liked the comments of the HIV doc at around the 8:00 mark in the second part.   Very good and got me a little choked up.  Of course, there are still so many questions: efficacy, distribution, cost, etc, but the science and their assembled team are fantastic.  Best of luck. 
« Last Edit: July 19, 2013, 09:45:08 AM by freewillie99 »
Beware Romanians bearing strange gifts

Online geobee

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Here's the second video -- Dr. Symond's talk after Louis Breton's talk.

http://www.youtube.com/watch?v=dVtCl4Vmt6k

Offline Hoyland

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The first cohort should have been dosed by now and so some preliminary data should be available in about another 4 months.

Has anyone heard any anecdotal comments about the study?


Offline JazJon

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I just checked in asking to confirm that I'm still on the list for 2013/2014

I was told that as soon as the last person in this cohort gets their infusion they will give me a call to start my treatment interruption for screening. 
(Probably sometime in November)

I'm still ready to do this and standing by.

Offline JazJon

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Video of Calimmune presentation to CIRM.

HIV/AIDS Stem Cell Clinical Trial: Louis Breton, CEO, Calimmune
http://www.youtube.com/watch?v=d5GSJeaAgP0

Here's the second video -- Dr. Symond's talk after Louis Breton's talk.

HIV/AIDS Stem Cell Clinical Trial: Geoff Symonds, Chief Scientific Officer, Calimmune
http://www.youtube.com/watch?v=dVtCl4Vmt6k

I forgot to say thanks for posting those videos, great updates!

Offline GoForIt

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I forgot to say thanks for posting those videos, great updates!

Thanks for re-posting these...I just watched them and my general feeling is hopeful and optimistic.  I think it takes very brave people to be apart of these trials and wish you, JazJon, all the luck in the world with this. 

I know I will be anxiously waiting to hear more.  Thanks again all who are contributing to keeping everyone informed on these medical advances in the pipeline.
08/09/2013   Diagnosed WB positive
08/20/2013   CD4-506(28%)  VL-10,800
09/12/2013   CD4-391(28%)  VL-14,900
09/17/2013   Start ART (Truvada & Tivicay)
10/11/2013   CD4-377(26%)  VL-UD
12/20/2013   CD4-590(??%)  VL-UD
03/18/2014   CD4-660(29%)  VL-UD
07/22/2014   CD4-613(29%)  VL-UD
08/01/2014    Start TAF Clinical Trial

Offline Matts

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If You are accidentally in Berlin You can visit tomorrow from 12.30 til 14.00  "HIV im Dialog" in the Red City Hall.
http://en.wikipedia.org/wiki/Rotes_Rathaus
Gero Hütter ( the man who cured T.Ray  Brown) and Prof. Joachim Hauber ( Tre-recombinase) are speaking about the newest cure research. I think it will be interesting, and it's for free. I am sure that Dr. Hütter will tell something new about CalImmune and his Gene trial.
http://www.hiv-im-dialog.de/index.php?id=40
tivicay/kivexa

Offline Hoyland

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The latest information released by the CIRM says that the Calimmune HIV trail has produced NO reports of serious safety events and that company is now planning the next trial of Cal-1 which will be conducted outside of the USA.


http://www.cirm.ca.gov/sites/default/files/files/agenda/131009_Agenda_10_Translational_Portfolio_Update_ICOC_1013_final.rev__0.pdf

Offline JungleJungle

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Just a question....blocking CCR5 isn't just the same used by the Entry Inhibitor as Fuzeon or Maraviroc??
I read that side effect about CCR5 receptor: "blocks the CCR5 coreceptor located on some immune system cells, there is a theoretical risk of developing infections and cancers."

Is that really a good choice to carry for a lifetime a genetically mutated immune system which is not effective anymore??
You need coolin', baby, I'm not foolin',
I'm gonna send you back to schoolin',
Way down inside honey, you need it,
I'm gonna give you my love,
I'm gonna give you my love.

Offline Matts

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As far as I know Maraviroc only bends the CCR5 out of shape- it's completely reversible and it only works as long as You take the drug. ZNF and CalImmune destroy the receptor forever. 4-16% of Europeans live quite well with this muation and are naturally immune against HIV. There some studies that MVC can prevent breast and prostate cancer, but You get more vulnerable for the West Nile Virus. I never heard before that there is a "theoretical risk of developing infections and cancers."
You can find more information here:
http://en.wikipedia.org/wiki/CCR5

tivicay/kivexa

Offline JungleJungle

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It is reported in the side effects of Maraviroc...i just did paste&copy from the drugs section of this website.
« Last Edit: October 11, 2013, 01:02:51 PM by JungleJungle »
You need coolin', baby, I'm not foolin',
I'm gonna send you back to schoolin',
Way down inside honey, you need it,
I'm gonna give you my love,
I'm gonna give you my love.

Offline JazJon

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The latest information released by the CIRM says that the Calimmune HIV trail has produced NO reports of serious safety events and that company is now planning the next trial of Cal-1 which will be conducted outside of the USA.


http://www.cirm.ca.gov/sites/default/files/files/agenda/131009_Agenda_10_Translational_Portfolio_Update_ICOC_1013_final.rev__0.pdf

Interesting :)

I asked about this and got a response.

"Hi Jon,
You know you are my number 1 guy right?! funny you mention CIRM, because they will be here next week! I believe what they are really planning to do is 'planned future ex US trials with same product in a different subgroup of HIV patients'  which means that they are going to look into other groups of patients outside of the US as well. That wont effect your participation in the study at all."

Offline Hoyland

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Did anyone attend the Calimmune and Sangamo presentations at the World Stem Cell Summit yesterday? Being in clinical trials and combining cell and gene technologies seems to give these two programs a high profile.

Offline JazJon

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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!"

Offline Hoyland

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This paper is the latest work published with collaboration from Geoff Symonds of Calimmune. This seems to be a different approach to Cal-1 but because its underpinning technology is the same the two could probably be incorporated into a single treatment at some future stage.

------
Despite prolonged and intensive application, combined antiretroviral therapy cannot eradicate human immunodeficiency virus (HIV)-1 because it is harbored as a latent infection, surviving for long periods of time. Alternative approaches are required to overcome the limitations of current therapy. We have been developing a short interfering RNA (siRNA) gene silencing approach. Certain siRNAs targeting promoter regions of genes induce transcriptional gene silencing. We previously reported substantial transcriptional gene silencing of HIV-1 replication by an siRNA targeting the HIV-1 promoter in vitro. In this study, we show that this siRNA, expressed as a short hairpin RNA (shRNA) (shPromA-JRFL) delivered by lentiviral transduction of human peripheral blood mononuclear cells (PBMCs), which are then used to reconstitute NOJ mice, is able to inhibit HIV-1 replication in vivo, whereas a three-base mismatched variant (shPromA-M2) does not. In shPromA-JRFL–treated mice, HIV-1 RNA in serum is significantly reduced, and the ratio of CD4+/CD8+ T cells is significantly elevated. Expression levels of the antisense RNA strand inversely correlates with HIV-1 RNA in serum. The silenced HIV-1 can be reactivated by T-cell activation in ex vivo cultures. HIV-1 suppression is not due to offtarget effects of shPromA-JRFL. These data provide “proof-of principle” that an shRNA targeting the HIV-1 promoter is able to suppress HIV-1 replication in vivo.

.....

Using the CD34+ cell–reconstituted NOJ model, we wish to explore a scenario closer to that which we envisage these constructs will be used in human HIV-1 treatment, primarily on cessation of antiretroviral drugs in controlled chronic infection to determine whether lentivirally delivered shPromA constructs can stabilize the viral reservoir on withdrawal of antiretroviral therapy. If the latent viral reservoir could be maintained as effectively silenced by shPromA treatment, these constructs would represent a substantial step forward on the road toward a functional cure, by providing an alternative to the currently proposed eradication strategies than using various viral transcription activating agents, such as histone deacetylase and demethylases.49,60,61 Rather than activating virus and abolishing infected cells, we propose that constructs such as shPromA could be used to lock HIV-1 into latency maintaining transcriptionally inactive virus even in patients ceasing conventional antiretroviral therapy, thus achieving a prolonged remission or functional cure of HIV-1 infection.

http://www.nature.com/mtna/journal/v2/n12/full/mtna201364a.html

Offline Hoyland

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Co-authored by Calimmune and Gero Hutter this paper explains more about the synergy between Cal-1  and the Berlin Patient.

www.mdpi.com/1999-4915/6/1/54/pdf

Quote
Abstract: Human immunodeficiency virus type 1 (HIV-1) infection of target cells requires CD4 and a co-receptor, predominantly the chemokine receptor CCR5. CCR5-delta32 homozygosity results in a truncated protein providing natural protection against HIV infection—this without detrimental effects to the host—and transplantation of CCR5-delta32 stem cells in a patient with HIV (“Berlin patient”) achieved viral eradication. As a more feasible approach gene-modification strategies are being developed to engineer cellular resistance to HIV using autologous cells. We have developed a dual therapeutic anti-HIV lentiviral vector (LVsh5/C46) that down-regulates CCR5 and inhibits HIV-1 fusion via cell surface expression of the gp41-derived peptide, C46. This construct, effective against multiple strains of both R5- and X4-tropic HIV-1, is being tested in Phase
I/II trials by engineering HIV-resistant hematopoietic cells.

Offline freewillie99

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I look forward to the day when these guys announce they've cured someone.  Big party.
Beware Romanians bearing strange gifts

Offline dico

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So what happened to the cohort 2?

Offline JazJon

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So what happened to the cohort 2?

No update yet, things got delayed until February/March last I heard. 

Offline dico

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It's really unfortunate to see how slow they are !

And you are in the 2nd cohort ?

Offline dico

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So no news about the 2nd Calimmune cohort ?

This clinical trial is the only ''cure'' trial. That's why it is so important to me. I tested poz 2 years ago and I turned 26 one month ago. I hope I can be cured before my 30th birthday.

I really envy those that are part of this trial (especially the 3rd cohort), but I live in Paris... I hope the Phase II/III will involve Parisian people ;)

Offline Hoyland

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Dico, just a rumour but I heard that the next phase will involve patients in the UK and Australia as well as the States.

Offline dico

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Nice !!

And did you hear any news about the gene therapy trial in Europz that was supposed to begin in 2014 ?

I think this trial is under the leadership of Ben Berkhout (Holland) ?

Thanks

Offline Hoyland

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Dico, I have not corresponded with Prof Berkhout for some time now. The last info I had is that he was on target but requires funding.

I suggest you correspond with him directly. He is a very friendly and helpful person and I am sure he will give you an honest opinion of where his team is at.

Offline Hoyland

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Yet another scientific paper supporting Calimmune's approach

http://www.nature.com/mt/journal/v22/n2/abs/mt2013264a.html?WT.ec_id=MT-201402

A lot of good scientific data, if only we could get some good trial data?

Offline dico

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Thank you very much for your answer.

I am pretty certain that the strategy of Calimmune is the good one. The only problem is the low engraftment (less than 20% of the cells) even with the chimio.  But the strategy of silencing hiv gene by Prof. Berkhout is very complimentary to the Calimmune trial. I hope they will merge their strategies in a combined phase II trial. Then this combined action with improved engraftment can really lead to a fonctional cure. Or I hope so. Because if this gene therapy fails, HIV sufferers will not have any hope of cure for the next 20 years.

I emailed Prof Alain Lafeuillade which is a French researcher very involved in the strategy of ''forever keeping the latent HIV dormant in the cells". He is angry to see all the millions that are spent on vaccines and other strategies doomed to failure. He thinks the Sangamo way of acting to be dangerous and unpratical. I agree with him.

I emailed Prof. berkhout today and I am waiting an answer. I hope he will answer.

If anyone has news about the clinical trial of Prof Berkhout or the Calimmune trial, it would be a pleasure to know more about them.

If Calimmune plans to do clinical trial in France, I will be among those that will be eager to be part of such a trial
« Last Edit: February 03, 2014, 12:47:04 PM by dico »

Offline dico

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Dico, I have not corresponded with Prof Berkhout for some time now. The last info I had is that he was on target but requires funding.

I suggest you correspond with him directly. He is a very friendly and helpful person and I am sure he will give you an honest opinion of where his team is at.

Unfortunately Prof Berkhout did not answer to my numerous mails... You are luckier than me. :(

Offline freewillie99

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I emailed Prof Alain Lafeuillade which is a French researcher very involved in the strategy of ''forever keeping the latent HIV dormant in the cells". He is angry..."

An angry Frenchman.  Shocker.
Beware Romanians bearing strange gifts

Offline Hoyland

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More pre-clinical data.

http://www.nature.com/articles/mtm201311#affiliations

Quote
Gene transfer has therapeutic potential for treating HIV-1 infection by generating cells that are resistant to the virus. We have engineered a novel self-inactivating lentiviral vector, LVsh5/C46, using two viral-entry inhibitors to block early steps of HIV-1 cycle. The LVsh5/C46 vector encodes a short hairpin RNA (shRNA) for downregulation of CCR5, in combination with the HIV-1 fusion inhibitor, C46. We demonstrate here the effective delivery of LVsh5/C46 to human T cell lines, peripheral blood mononuclear cells, primary CD4+ T lymphocytes, and CD34+ hematopoietic stem/progenitor cells (HSPC). CCR5-targeted shRNA (sh5) and C46 peptide were stably expressed in the target cells and were able to effectively protect gene-modified cells against infection with CCR5- and CXCR4-tropic strains of HIV-1. LVsh5/C46 treatment was nontoxic as assessed by cell growth and viability, was noninflammatory, and had no adverse effect on HSPC differentiation. LVsh5/C46 could be produced at a scale sufficient for clinical development and resulted in active viral particles with very low mutagenic potential and the absence of replication-competent lentivirus. Based on these in vitro results, plus additional in vivo safety and efficacy data, LVsh5/C46 is now being tested in a phase 1/2 clinical trial for the treatment of HIV-1 disease.

Offline freewillie99

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More pre-clinical data.

http://www.nature.com/articles/mtm201311#affiliations

It's humbling reading down through all those supporting references (a few of which go back to 1996) just how much work has been carried out to get to this point.  May there be a second Nobel for Dr. Baltimore and company in the near future. 
Beware Romanians bearing strange gifts

Offline dico

  • Member
  • Posts: 85
Hi Hoyland.

Just wanted to tell you that prof. Berkhout does not answer to my mails...

And is anybody here who is included in the cohort 2 of the Calimmune clinical trial? When it will begin ?

Thank you

 


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