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Author Topic: Gene therapy results due?  (Read 14786 times)

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Offline lonbjny

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  • Posts: 26
Gene therapy results due?
« on: February 09, 2007, 02:59:20 PM »
Hi, last year I heard reports about a gene therapy phase 1 or 2 trial (involving Johnson & Johnson) that was due to release results in Feb 07.

It has approx 70 recruits with 50% on placebo.

One guy went public with his results as he had achieved undetectable viral load.

Does anybody know the trial. And does anybody know anything about the due date for results?

thanks

Offline J220

  • Member
  • Posts: 587
Re: Gene therapy results due?
« Reply #1 on: February 09, 2007, 05:41:14 PM »
I think you are referring to the ribozyme gene therapy trial. If so, yes, the last I heard they were due to release data in feb 07. I think I still have the email of the person who I had contacted, the one who decided to speak to the media about his promising results.

And incidentally last time we corresponded he said that he was not constantly  undetectable, but rather his vl bounced up and down from undetectable up to a few thousand. But this is certainly still good, espacially because the body was able knock back down any spike, completely on its own, thanks to the therapy. Let's see what he can share with us about this, but we'll naturally be looking forward to the official data release.

I do remember a phrase that one of the doctors in the trial used, when speaking to the media about this technique: "I think the starts are lining up on this one." Here's to that being true! J.
« Last Edit: February 09, 2007, 05:43:08 PM by J220 »
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline J220

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Re: Gene therapy results due?
« Reply #2 on: February 09, 2007, 05:51:11 PM »
I found the original article, from http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/04/07/MNGH6I59Q61.DTL&type=health.


HIGH HOPES FOR AIDS THERAPY
Experimental treatment fortifies the body's own stem cells with an enzyme that could block the virus' relentless advance

Sabin Russell, Chronicle Medical Writer

Friday, April 7, 2006

Michael DeLane is about to celebrate a rare anniversary. On Saturday, it will be one year since he stopped taking all his drugs for AIDS.

Many patients have experimented with breaks from their AIDS medications, and a few of these have been able to keep their virus levels in check for a year or more.

What makes DeLane's case important is that he is among a small group of HIV-infected men and women participating in an unusual experiment. Half of them have had their own blood cells modified with a gene that blocks the virus.

Today, the 41-year-old San Francisco man is in good health and fine spirits.

If the experimental therapy is proved successful, it could raise the prospect that infected individuals could control the virus and maintain their health without having to spend a lifetime taking costly and potentially toxic drugs.

"It's possible that the stars are lining up on this one,'' said Dr. Jay Lalezari, a UCSF researcher who conducts clinical trials for drugmakers and has enrolled patients in this study. But he cautioned that the experience of a single patient has little scientific meaning. "The technology has proven itself in various ways, but we won't know the results of this trial until February,'' he said.

The goal of this experiment -- which combines elements of genetic engineering, gene therapy and stem cell science -- is to create a kind of parallel immune system that is fortified against the AIDS virus.

Like the 73 other participants in the clinical study, DeLane does not know for certain whether he was among the half who received the modified gene or was given a placebo. What he does know is that his T-cell count -- a measure of infection-fighting white blood cells -- has more than doubled.

Although he remains HIV-positive, the level of virus in his bloodstream is currently undetectable.

"It was such a burden to be lifted, to be no longer connected to the pills,'' said DeLane, a former Greenpeace activist now working as an administrator for the UCSF Medical Group.

DeLane was among the first to participate in the experiment, which he learned about because he has closely monitored HIV science since he became infected in August 2002.

Similar experiments are being carried out at UCLA and in Sydney, where the technique was developed by a small research company owned by Johnson & Johnson, the New Brunswick, N.J., medical giant.

Although DeLane was among the first to participate, the researchers have only recently performed the treatment on the last of their volunteers. Preliminary results of the trial won't be ready until February.

Johnson & Johnson spokesman Marc Monseau declined to discuss the treatment. "The trial is ongoing, and we prefer not to comment about ongoing trials,'' he said.

The secret of this new gene-therapy approach to controlling HIV is an enzyme called a ribozyme. It is a custom-built chemical "scissors," designed by Australian researchers, that cuts up one of HIV's nine genes just as the virus tries to replicate itself. Certain types of white blood cells are the natural target of HIV. But researchers believe that if these same cells are equipped with this man-made enzyme, they cannot be infected.

Because the body does not naturally produce this ribozyme, researchers had to come up with a way to cause blood cells to manufacture it. The answer was found in the emerging science of stem cells.

The stem cells chosen for this experiment are not the controversial kind found in human embryos, but grow naturally in bone marrow and float about in the bloodstream. They are literally the mother of all blood cells -- they morph into the many kinds of white cells that fight infection -- and are the favorite target of HIV.

Participants in the gene therapy experiment follow a procedure developed by the Australian scientists, led by Johnson & Johnson researcher Geoff Symonds.

First, the volunteers spend two eight-hour shifts hooked to a machine that filters out stem cells and returns the rest of their blood to their arm.

Next, the harvested stem cells are infected in the laboratory with a harmless mouse virus engineered to carry the ribozyme gene. The genes are a blueprint that tell the cell how to make the enzyme. Three days after the gene is transferred to the stem cells, they are returned to the patient's bloodstream. In subsequent weeks, these stem cells produce a variety of infection-fighting white blood cells, each containing the ribozyme that can ward off HIV.

(In the experiment, only half the subjects receive stem cells containing the gene. The rest receive unaltered stem cells as a placebo.)

The hope is that when HIV attempts to infect these fortified blood cells, the virus will be destroyed. As time goes by, these fortified blood cells would eventually outlive the natural blood cells -- and the patient would be left with a rebuilt immune system resistant to HIV.

DeLane was infused with either the treated blood cells or a placebo at a Stanford University Medical Center clinic in June 2004. He strongly believes that he received the treated cells, because for several months after the procedure his blood counts fluctuated wildly, as if a battle were going on in his immune system. Forty weeks after the infusion, he stopped taking antiviral drugs.

The Chronicle has learned that DeLane is not the only patient in the stem cell study to maintain undetectably low levels of virus, although the number is a closely guarded secret.

Word that some participants were doing well has been circulating among AIDS activists for several months. DeLane's experience with the Stanford trial is the first to be publicized -- but only because he chose to share the test results with reporters.

Perhaps the most intriguing development in his case was in February when the level of virus in his bloodstream jumped into the detectable range -- the first sign that perhaps the therapy was failing. But in March, the so-called "viral load" test slipped back into the undetectable range -- suggesting that DeLane's immune system, newly fortified or not, beat back the infection without any help from AIDS drugs.

"It's a fascinating case,'' said Dr. Steve Deeks, a UCSF researcher. Deeks was not involved in the clinical trial, but is an expert on the reaction of the immune system in HIV patients who stop taking their medications.

Deeks said it is possible that DeLane is one of those patients who can naturally control the virus without drugs, and his encouraging results may have nothing to do with the therapy. "Long-term control of the virus in the absence of treatment is rare, but it does happen,'' said Deeks.

Scientists involved in the study remain cautiously optimistic. Dr. Ronald Mitsuyasu, director of the UCLA Center for Clinical AIDS Research, is running the study in Los Angeles and collaborated with the Australian team on the first pilot test of the new therapy. It showed that the procedure was safe, and that the anti-HIV ribozyme installed in stem cells turned up in the many white blood cells that derived from them.

Researchers have improved the technique of transferring the gene to stem cells so that 90 percent of the harvested stem cells are returned carrying the ribozyme.

The AIDS scientist said he does not believe this type of therapy will ever fully replace effective antiviral drugs. However, "if we are intelligent in how we use the drugs with these immune therapy approaches, it could lead to extremely effective control of HIV,'' Mitsuyasu said.

Stem cell HIV treatment:

1 Aphoresis

Blood is removed from the body, filtered to remove stem cells and returned to the body. The process takes up to 16 hours.

2 Modifying stemcells

Retrieved stem cells are "infected" with a harmless mouse virus carrying a ribozyme gene.

3 Fortified stemcells

Three days later, the stem cells fortified with the ribozyme gene are reintroduced into the patient.

4 Cell change

Fortified stem cells differentiate into white blood cells such as monocytes, neutrophils, T-cells, B-cells. All can now produce the ribozyme, which blocks HIV infection.

E-mail Sabin Russell at srussell@sfchronicle.com.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline Ihavehope

  • Member
  • Posts: 1,366
  • Yes, I'm a cry baby, AND WHAT?
Re: Gene therapy results due?
« Reply #3 on: February 09, 2007, 06:01:39 PM »
Please let this be true. PLEASE GOD.
Infected: April 2005
12/6/06 - Diagnosed HIV positive
12/19/06 - CD4 = 240  22% VL = 26,300
1/4/07 - CD4 = 200 16% VL = ?
2/9/07 = Started Kaletra/Truvada
3/13/07 = CD4 = 386 22% VL ?

Offline denniss

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  • Posts: 37
Re: Gene therapy results due?
« Reply #4 on: February 10, 2007, 08:03:43 AM »

Offline lonbjny

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  • Posts: 26
Re: Gene therapy results due?
« Reply #5 on: February 10, 2007, 12:01:40 PM »
Thanks. As usual you guys are great at helping out with questions.

I was particularly interested in this as I believe that there needs to be alternate research strands to the traditional HAART approach.

(-and also I am delighted to say I am a hopeless optimist)

Please post any other news you come across.

Big love :)

Offline bimazek

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  • Posts: 781
Re: Gene therapy results due?
« Reply #6 on: February 10, 2007, 11:46:20 PM »

I met a a guy in my support group who went thru gene therapy AND HAD EXACTLY THE SAME GOOD RESULTS AS WRITTEN ABOVE, HE HAS BEEN OFF OF MEDS FOR A YEAR AND HALF OR SO, AND

Offline bimazek

  • Member
  • Posts: 781
Re: Gene therapy results due?
« Reply #7 on: February 10, 2007, 11:49:20 PM »
I pressed the wrong button,  i was saying, he has been off meds for a long time over a year almost 2 and he has also been in the undetectable range the whole time, sometime he has gone up to like a very small viral load like max of 1000 which is nothing really, and then back down, he was at ucla, i talk to him, via phone and email, he was not the one that went to the media, anyway

there is great signs of hope and scientific progress

but we need to work hard now

to get the govt and drug companies and hiv orgs to start prepping for these new therapies

in large numbers

asap


Offline bimazek

  • Member
  • Posts: 781
Re: Gene therapy results due?
« Reply #8 on: February 11, 2007, 02:12:42 AM »
this is a different trial... but check out this animation...
it was hard to find on the companies website, none of the news reporters bothered to dig into the story and find this link...
The results were astounding. patient's T-cell levels not only stopped dropping but also dramatically increased in some patients                   
          VIRxSYS is currently conducting clinical trials for VRX496.
                see this animation... we may need to do activism to get this widely available if it works in the study

               http://www.virxsys.com/pages/human-therapies/first-clinical-application/how-vrx496-works.php
                       
 scientists in a Manhattan laboratory are in the midst of studies that would put the pathogen to noble use.
         
Gene Therapy Shows Promise Against HIV
Gene-base therapy may be effective against HIV, U.S. researchers report.
An investigational gene-based immunotherapy called VRX496 suggests it can fight the virus, according to a phase I, open-label, non-randomized clinical trial conducted at the University of Pennsylvania School of Medicine.
The trial evaluated the safety and tolerability of VRX496 -- a CD4 T cell treatment -- in five people with chronic HIV infection who had all failed to respond to at least two antiretroviral drug regimens.
In response to the treatment, the five patients experienced decreases

Offline bmancanfly

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  • Posts: 554
  • Medicare For All !
Re: Gene therapy results due?
« Reply #9 on: February 13, 2007, 10:23:26 PM »
I've had my eye on this for some time.  I think it has great near term promise. 

I'm surprised how like attention this has gotten by the main stream media and even by POZ sites like this.

We often hear glowing reports about drugs, barely in the test tube stage, as the next "cure".   This "seems" to be actually working in real people and so close to becoming reality.  Even if not a cure it seems to be a great new way of battling the bug.

Let's hope
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline bmancanfly

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  • Posts: 554
  • Medicare For All !
Re: Gene therapy results due?
« Reply #10 on: February 26, 2007, 05:34:25 PM »
The results of the trial were supposed to be released in February and still no news.

 Has anyone heard anything about this ?
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline NYCguy

  • Member
  • Posts: 180
Re: Gene therapy results due?
« Reply #11 on: February 27, 2007, 01:44:23 PM »
Been wondering about this one myself and waiting patiently this whole month...and now it's almost March. Any ideas as to where they will report?
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline Optimistic

  • Member
  • Posts: 326
  • An Apple A Day Keeps The Doctors Away!
Re: Gene therapy results due?
« Reply #12 on: February 27, 2007, 02:24:51 PM »
I have been waiting patiently for the results as well.....I've tried searching for information over the web, but no luck.  I think the results are suppose to be published in the "Proceedings of the National Academy of Sciences" (but i'm not really sure about this).

I would call or email Dr. June and Dr. Levine at the University of Pennsylvania, both of whom is conducting the study, but I could not find any contact info.

Justin
12/06 (Atripla): cd4 - 260; cd% - 33%; vl - 169
1/07 (Atripla): cd4 - 267; cd% - 38.1%; vl - 132
4/07 (Atripla): cd4 - 373; cd% - 33.9%; vl - <50
7/07 (Atripla); cd4 - 287; cd% - 35.8%; vl - <50
9/07 (Atripla); cd4 - 356; cd% - 39.5%; vl - <50
12/07 (Atripla); cd4 - 517

Offline FiercenBed

  • Member
  • Posts: 183
Re: Gene therapy results due?
« Reply #13 on: February 27, 2007, 06:49:20 PM »
i went to n.y. to apply for the  VIRxSYS  trial. was excluded cause i had had ks <cant get a break>. anyway i heard from the horses mouth:

1>this is no cure
2> there currently in phase 2
3>phase 2 should b done in november
4> there were only 5 people in phase 1.

but good news is good news!

Offline Jake72

  • Member
  • Posts: 145
Re: Gene therapy results due?
« Reply #14 on: February 28, 2007, 11:50:06 AM »
That's great, but what exactly is the good news?  It's not a cure, but what is it (or what is it supposed to be?)? 
If it really is supposed to provide effective, relatively non-toxic (and, ideally, relatively inexpensive) long-term HIV control without the use of meds, then great!

If it's something that's ultimately supposed to be taken in addition to-and concurrently with-HAART forever, then ho-hum. 
« Last Edit: February 28, 2007, 11:54:56 AM by Jake72 »

Offline Optimistic

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  • Posts: 326
  • An Apple A Day Keeps The Doctors Away!
Re: Gene therapy results due?
« Reply #15 on: February 28, 2007, 12:09:41 PM »
That's great, but what exactly is the good news?  It's not a cure, but what is it (or what is it supposed to be?)? 
If it really is supposed to provide effective, relatively non-toxic (and, ideally, relatively inexpensive) long-term HIV control without the use of meds, then great!

If it's something that's ultimately supposed to be taken in addition to-and concurrently with-HAART forever, then ho-hum. 

I believe that this gene therapy is suppose to be effective and non-toxic in keeping the viral load at low levels without the use of HAART...in terms of the pricing, i'm not sure about that.

Justin
12/06 (Atripla): cd4 - 260; cd% - 33%; vl - 169
1/07 (Atripla): cd4 - 267; cd% - 38.1%; vl - 132
4/07 (Atripla): cd4 - 373; cd% - 33.9%; vl - <50
7/07 (Atripla); cd4 - 287; cd% - 35.8%; vl - <50
9/07 (Atripla); cd4 - 356; cd% - 39.5%; vl - <50
12/07 (Atripla); cd4 - 517

Offline NYCguy

  • Member
  • Posts: 180
Re: Gene therapy results due?
« Reply #16 on: February 28, 2007, 04:58:58 PM »
My impression is that the Johnson/Tibotec therapy that was supposed to be released in Feb may be effective without HAART, as patients in the trial were removed from HAART.  From what I've read, it may also be more effective than the Virxsys treatment.  However, it's also more intrusive/invasive as it requires something like four 8-hour days being hooked up to a machine to process your blood.

This is just based on the articles I've read plus postings from one guy who the Virxsys treatment didn't work for (I think he was the 5th guy of the "4 out of 5") and he was pretty unhappy with the whole thing. 

However, there still isn't enough info out there for us to really judge on.  When will they report?!
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline NYCguy

  • Member
  • Posts: 180
Re: Gene therapy results due?
« Reply #17 on: February 28, 2007, 05:00:58 PM »
J - maybe you could contact the guy you know in the study and ask him if he knows when/where official results will be published?
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline Optimistic

  • Member
  • Posts: 326
  • An Apple A Day Keeps The Doctors Away!
Re: Gene therapy results due?
« Reply #18 on: February 28, 2007, 06:37:03 PM »
J - maybe you could contact the guy you know in the study and ask him if he knows when/where official results will be published?

I emailed Dr. June and Dr. Levine about the publication of the results, but no response yet. As soon as I hear from them I will update everyone.

Justin
12/06 (Atripla): cd4 - 260; cd% - 33%; vl - 169
1/07 (Atripla): cd4 - 267; cd% - 38.1%; vl - 132
4/07 (Atripla): cd4 - 373; cd% - 33.9%; vl - <50
7/07 (Atripla); cd4 - 287; cd% - 35.8%; vl - <50
9/07 (Atripla); cd4 - 356; cd% - 39.5%; vl - <50
12/07 (Atripla); cd4 - 517

Offline bimazek

  • Member
  • Posts: 781
Re: Gene therapy results due?
« Reply #19 on: March 01, 2007, 04:17:35 AM »

I met someone in my support group who had a gene therapy at UCLA which sounds similar to the Johnson/Tibotec mentioned above and he was off meds for over a year and good results no real increase in VL

where is Johnson/Tibotec being done?  What city?

The problem with any system that takes alot of hardware (like kidney dialysis) is that there would need to be activism to get it widely available

anyone know more about  Johnson/Tibotec

is this it???

http://www.google.com/search?hl=en&q=Johnson+Tibotec++hiv+gene&btnG=Search


AIDS vaccine, HIV vaccine research: IAVIReportOnline.org
The DNA component of the vaccine contains one HIV gag gene (clade C) plus 5 HIV ... (IPM) and Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson, ...
www.iavireport.org/Issues/0404/VaccineBriefs.asp


THIS IS AN AMAZING ARTICLE AND HAS DOZENS OF NEW THERAPIES AND TREATMENTS AND VACCINES THAT ARE IN THE WORKS...  WORTH READING IF YOU WANT TO HOPE AND RECENTLY WRITTEN 2005
this has some info on gene therapy
http://72.14.253.104/search?q=cache:mIurCyhlLnIJ:www.aethlonmedical.com/pdfs/IndustryReport.pdf+Johnson+Tibotec+hiv+gene&hl=en&ct=clnk&cd=2&gl=us

Immune-based therapy will most likely play a major role in fighting HIV in the future. The immune
modulators are designed to help the efforts of one or more of the ďarmsĒ of the immune system:
antibodies; natural killer cells; killer T cells; and helper T cells. In addition, the immune modulators
may also prove effective at flushing out latent virus that may remain hidden in many cells and
lymphoid tissues of the body (and virtually undetected in the blood). This reservoir of latent cells is
believed to be one of the major barriers to completely eliminating HIV from a personís body.
Companies that are currently pursuing various immune therapy strategies include many well-
known drug companies including Chiron Corporation (NASDAQ: CHIR); Bayer Corporation
(NYSE: BAY); and GlaxoSmithKline (NYSE: GSK).


The goal of developing an HIV vaccine is an area of great interest to scientists and drug
manufacturers alike. Although progress toward a vaccine has been a slow process with numerous
failures in the clinc, in the past few years remarkable strides have been made toward a vaccine for
HIV. In the twelve months after June 2003 thirteen vaccine candidates moved into Phase I trials.
Thatís the highest number of Phase I trials initiated in any single year since the search for a
vaccine began. A major reason for the increased number of vaccine candidates and the progression
of these candidates is the development of international organizations in support of finding an AIDS
vaccine. Many vaccines are currently being tested utilizing recombinant viral vectors, DNA vaccines
and combinations of peptides and lipids to deliver the vaccine. Some researchers anticipate that in
developing countries between the years 2005 and 2010 some 44,000 people will participate in
approximately five Phase II/B and Phase III trials of AIDS vaccines spanning fifteen countries and
some 52,000 will participate in approximately ten Phase II/B and Phase III Non-vaccine HIV
prevention trials, including microbicide trials spanning twelve countries.

The potential for large revenues as well as the HIV marketís rapid growth have made it very
attractive to large pharmaceutical companies such as GlaxoSmithKline, Gilead, Bristol-Myers
Squibb, Merck & Co., Roche, Pfizer, Abbott Laboratories and Boehringer Ingelheim. Expansion of
screening programs and the increase in the diagnosis rate for HIV is expected to further bolster the
patient population available for treatment and thus drive the value of the market. Growth in the
global HIV market is expected to create opportunities to expand sales for drug companies currently
in the market while still opening opportunities for more novel drugs from other drug companies. To
battle the development of growing resistance and declining immune responses, the addition of more
entry inhibitors and immune based adjunct therapies will influence the current market share of
many companie

Offline Optimistic

  • Member
  • Posts: 326
  • An Apple A Day Keeps The Doctors Away!
Re: Gene therapy results due?
« Reply #20 on: March 01, 2007, 03:39:31 PM »
This is one study that I am really looking forward to see the results.....My doc told me once, couple years ago, that ucla is working on gene therapy and she thinks that this could be it.

Justin
12/06 (Atripla): cd4 - 260; cd% - 33%; vl - 169
1/07 (Atripla): cd4 - 267; cd% - 38.1%; vl - 132
4/07 (Atripla): cd4 - 373; cd% - 33.9%; vl - <50
7/07 (Atripla); cd4 - 287; cd% - 35.8%; vl - <50
9/07 (Atripla); cd4 - 356; cd% - 39.5%; vl - <50
12/07 (Atripla); cd4 - 517

Offline NYCguy

  • Member
  • Posts: 180
Re: Gene therapy results due?
« Reply #21 on: March 01, 2007, 05:02:52 PM »
Bizmazek - I am pretty sure the Johnson/Tibotec study is the same one referred to in the article J220 references above:

http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/04/07/MNGH6I59Q61.DTL&type=health

UCLA is one of the study sites.  There is a full list of sites and more info here:

http://www.clinicaltrials.gov/ct/show/NCT00074997?order=19

you can also see that the last follow-up was Jan 2007, which makes sense that results would be out in Feb.
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline Jake72

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Re: Gene therapy results due?
« Reply #22 on: March 01, 2007, 10:24:12 PM »
Thanks for the links...very interesting news!  Considering that this lengthy (4+ years) Phase II trial has likely just ended, does this mean that the therapy will move right into Phase III (and not a 4+ year Phase IIB or something like that) if the results are encouraging?   

Even if the technique requires four eight-hour days of being hooked up to a machine, that would still beat the round-the-clock, year-in/year-out toxic pill therapy we're currently taking.

Offline hahaha

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Re: Gene therapy results due?
« Reply #23 on: March 08, 2007, 02:56:12 AM »
Hi, last year I heard reports about a gene therapy phase 1 or 2 trial (involving Johnson & Johnson) that was due to release results in Feb 07.

It has approx 70 recruits with 50% on placebo.

One guy went public with his results as he had achieved undetectable viral load.

Does anybody know the trial. And does anybody know anything about the due date for results?

thanks

I know I am a bit impatient.  But is there any thing updated for this J & J Gene Therapy result?  I can't wait to see if it works for us or not.

Or....is it because the result is bad so J & J do not want to publish it?   :'(  I am a bit worry..........
Tell me. PLLEEEEEAAAASSSSEEEE.



Aug 9, 2006 Get infected in Japan #$%^*
Oct 2006 CD4 239
Nov 2006 CD4 299 VL 60,000
Dec 1, Sustiva, Ziagan and 3TC
Jan 07, CD4 400

Offline NYCguy

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Re: Gene therapy results due?
« Reply #24 on: March 08, 2007, 02:14:36 PM »
I've been trolling the internet daily for news (no, not for boys...well, sometimes, lol) and haven't seen anything yet.  If anyone does, please post.
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline Optimistic

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Re: Gene therapy results due?
« Reply #25 on: March 08, 2007, 03:41:27 PM »
One of the researchers from the University of Pennsylvania, Dr. Levine emailed me back. This is what he said:

Hi Justin,
 
Depending on your scientific interest, you may wish to read the Penn press release on the HIV gene therapy paper http://www.uphs.upenn.edu/news/News_Releases/nov06/HIVgenether.htm or the original article in the Proceedings of the National Academy of Sciences here http://www.pnas.org/cgi/content/full/103/46/17372
 
We have a study in Philadelphia currently recruiting.  You can find more information at http://www.clinicaltrials.gov/ct/show/NCT00295477?order=1  The contact person for more information on eligibility is Larisa Zifchak- 215-349-8091 or Larisa.Zifchak@uphs.upenn.edu.
 
Bruce Levine, Ph.D.

Associate Professor,
Department of Pathology and Laboratory Medicine
Abramson Cancer Center
University of Pennsylvania


Justin
12/06 (Atripla): cd4 - 260; cd% - 33%; vl - 169
1/07 (Atripla): cd4 - 267; cd% - 38.1%; vl - 132
4/07 (Atripla): cd4 - 373; cd% - 33.9%; vl - <50
7/07 (Atripla); cd4 - 287; cd% - 35.8%; vl - <50
9/07 (Atripla); cd4 - 356; cd% - 39.5%; vl - <50
12/07 (Atripla); cd4 - 517

Offline J220

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Re: Gene therapy results due?
« Reply #26 on: March 08, 2007, 04:41:59 PM »
One of the researchers from the University of Pennsylvania, Dr. Levine emailed me back. This is what he said:

Hi Justin,
 
Depending on your scientific interest, you may wish to read the Penn press release on the HIV gene therapy paper http://www.uphs.upenn.edu/news/News_Releases/nov06/HIVgenether.htm or the original article in the Proceedings of the National Academy of Sciences here http://www.pnas.org/cgi/content/full/103/46/17372
 

I think that is a different one than the Ribozyme therapy mentioned at the beginning of the post. Not that the VRX496 isn't promising, but the results that were expected in Feb 07 were for the ribozyme trial. Still waiting for those results!
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline NYCguy

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Re: Gene therapy results due?
« Reply #27 on: March 09, 2007, 04:46:15 PM »
Yes, you're right J.  They're both gene therapies, just different approaches and on different tracks.  The Ribozyme study should be reporting anytime, or so it would seem.

It's good to know that the VIRxSYS study is moving forward, however.
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline Zanarkand

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Re: Gene therapy results due?
« Reply #28 on: March 09, 2007, 05:44:27 PM »
Extremely promising, evolving our bodies is the way to go.
However

If these results are for sure, why isn't it avaliable to the public?
It seems like the study has gone missing.
I think I'm missing something....

I understand this is not a cure, but it's certainly one giant step closer.
It's managment without drugs.
I think there should be a new term for it or something...

Cuz it's not a cure. Yet it controls the virus without any input from humans.
It would surely replace the need for ARVS..

I think the next step will be cellular internal counter-mechanisms

Lets call it a GMAT - Genetically Modified Antiretroviral Treatment ?
All Your Base Are Belong To Us

Offline J220

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Re: Gene therapy results due?
« Reply #29 on: March 09, 2007, 06:36:26 PM »
Extremely promising, evolving our bodies is the way to go.
However

If these results are for sure, why isn't it avaliable to the public?
It seems like the study has gone missing.
I think I'm missing something....

I understand this is not a cure, but it's certainly one giant step closer.
It's managment without drugs.
I think there should be a new term for it or something...

Cuz it's not a cure. Yet it controls the virus without any input from humans.
It would surely replace the need for ARVS..

I think the next step will be cellular internal counter-mechanisms

Lets call it a GMAT - Genetically Modified Antiretroviral Treatment ?

It's not a 'sure' thing until the clinical trials are complete, and it won' be until then that it will be available to the public...
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline Zanarkand

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Re: Gene therapy results due?
« Reply #30 on: March 09, 2007, 07:16:12 PM »
Well, if GMAT reduces viral load to undetectable and keeps it there... Even if it's not forever
Isn't that sign enough that it works?
A lot of people are out of options for treatment, does it really matter if it's 100% or not?
What it currently does is what everyone wants.
If word comes back and they say "it fails"
I think we should take action and demand an explination because those 5 lucky people on trial are currently better off than the rest of the world.
All Your Base Are Belong To Us

Offline J220

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Re: Gene therapy results due?
« Reply #31 on: March 09, 2007, 08:36:46 PM »
I think you need to get better acquainted about how clinical trials work, things are not as simple as you see them!

To begin with there is a concern that this gene therapy approach (and please, let's not start making up pseudo-scientific names for these treatments) can cause cancer. The animal models on which the ribozyme vector was tested had a high incidence of cancer, so this is a genuine concern. This may not translate into human side effect, but it must be approached slowly.

Second when you say let's demand an explanation about the five people, what exactly are you wanting to have explained? The trial is not over, plain and simple, and nothing can be done until the trials are over, end of the story.

Having said that, there are compassionate release parameters that could allow those who are at terminal stage to have access to some experimental medicines and such, but I am not sure this includes gene therapy. So bottom line, patience, and optimism, are the key. Things are moving, rest assured and I expect great things in the next year or so from a few of the best treatment/ therapy candidates out there.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline bimazek

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Re: Gene therapy results due?
« Reply #32 on: March 10, 2007, 03:50:05 AM »
j220 hit the nail on the head when he said, "there is a fear of gene therapy approaches can cause cancer."

i spoke with a west coast expert and he said that a few weeks ago

but like anything in body, some will some wont be effected.  it is intesting question.,... for example if you have HepC there is a 9% chance of cancer after 25 -35 years or something, i am totally not sure of %, but my point is...

if gene therapy (and i am just saying this there is no evidence or science to support this i know of) but lets say that gene therapy is 2 times more likely to give cancer than HepC 18% ... would it be worth taking gene therapy if after 25-35 years you have an 18% chance of cancer with say a 70% cure rate with the cancer...

are the haart side effects so bad that you would take that chance i never took meds yet so i dont know

what are your thoughts

Offline Zanarkand

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Re: Gene therapy results due?
« Reply #33 on: March 10, 2007, 05:38:35 AM »
Well, it makes sense.

When you force mutations, obviously some of the cells don't "evolve" as planned and go crazy.
Lets say everyone who recieves the treatment develops cancer.
A lot of people who are on cd4 50 and vl in the millions would kill for a chance to turn the tables.
Cancer isn't nice. I'm not in any way saying that it's better than HIV.
But if Cancer is to be expected-
Go for tests every month and treat it early if anything.

What I'm saying is: A lot of people will probably die because they don't release preliminary treatments.

Those are the people who should be given the treatment regardless of side-effects
On the other hand, the treatment could prove fatal.
But that's the chance you take.

J, I'm not withdrawing my made up term. I'll say what I want kthx
All Your Base Are Belong To Us

Offline J220

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Re: Gene therapy results due?
« Reply #34 on: March 10, 2007, 03:38:54 PM »
Yes, someone who has no other options will decidedly want to take a chance, but look at it form the pharmaceutical company's standpoint. They will never release any gene therapy that can cause cancer. Imagine the liability issues! It just doesn't work that way. And of course, Zanarkand, you are inherently free to use whichever term you want, for anything and everything- it's just that I am not sure this belongs in the scientific realm.
« Last Edit: March 11, 2007, 02:29:19 PM by J220 »
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline Zanarkand

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Re: Gene therapy results due?
« Reply #35 on: March 11, 2007, 07:51:53 AM »
I undertand, but then it should be avaliable as "Use At Own Risk"

If it takes years for scientists to create a term other than Vaccine then ya.
I'll make up a term for the meantime

All Your Base Are Belong To Us

Offline NYCguy

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Re: Gene therapy results due?
« Reply #36 on: March 12, 2007, 02:05:47 PM »
Ya'll, this is a very interesting discussion (and I didn't know about the potential cancer issues with gene therapy, so thanks for that), however we just won't know how well this works until the data comes out, which won't happen until the trials end, which hasn't happened yet for for the Virsxyx therapy.  But the Tibotec trial ended in Jan, so it does seem strange they haven't reported.  I also thought it was strange that there is no mention of this trial on their website, just their new Nukes.  Thoughts on that?

11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline Jake72

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Re: Gene therapy results due?
« Reply #37 on: March 12, 2007, 10:15:56 PM »
I'm also eager to see the results of the trial that has just ended, but doesn't it ordinarily take awhile (a couple of months?) to collect, enter, and interpret the data before making a conclusion and a corresponding announcement?   The results were supposed to be available in February, and it's only early/mid-March.  Believe me, I'd love to hear something about this, but I'd rather wait a little longer for concrete, accurate results rather than a sloppy 'rush job'.

It could be that the results are really astounding, so they're taking time to double- or triple-check to confirm the results (now there's optimism for you!).
« Last Edit: March 12, 2007, 10:22:43 PM by Jake72 »

Offline ScienceGuy25

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Re: Gene therapy results due?
« Reply #38 on: March 13, 2007, 10:26:54 PM »
Hey Guys

I haven't posted in awhile, busy stuyding.  But I wanted to chime in here on this discussion. Let me tell you I'm somewhat biased as I work for a very large Center for Cell and Gene Therapy in the US.  Like J220 said if it is found that any of these gene therapies cause a significant increase in the risk of cancer they will never be approved as a treatment for humans. This is the way the system is set up, they won't allow trading one disease for another. This actually happened in the case of children with severe combined immunodeficiency - a very promising gene therapy was developed which allowed these "bubble kids" to regain fairly normal immune systems and start living the lives of normal kids, attend school etc etc.  Unfortunately it was later found that many of these kids developed lymphomas and the trial was halted.


Of course as I said I'm biased in favor of gene therapy. So the HOWEVER is, new and exciting techniques are being developed in the laboratory every day and the National Institutes of Health in the United States has been pushing scientists and doctors to work together to move discoveries from the lab bench to the patient beside faster. Science will put out new and better treatments (drugs and cell/gene therapies) and one day a vaccine.

While we've not had a cure or vaccine yet - think about how much progress has been made. It will come.

Best
ScienceGuy

Offline bimazek

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Re: Gene therapy results due?
« Reply #39 on: March 21, 2007, 03:24:24 AM »
scienceguy, very interesting post and great to hear from some one close to the research, i wish there were some PhDs or MDs or even genius grad students on here that would post

two thoughts... haart is known to increase risks of many cancers, perhaps it reduces the risk of many other cancers if the hiv patient is not on haart but it may increase some .. very complex statistical analysis needed for cost benefit ratio of these things..

( i know they halted that gene therapy for the bubble kids but there were alot of cancers right? like a high %, so i can see why they stopped, but even if it gave a kid 3-5 years out of the bubble... i dont know..).

 i think haart qualifies in relation to your phrase, but haart has been approved, so i think it is a matter of degrees, if the treatment extends life tremendously as haart has proven to do and reduces many cancers that hiv not on haart...   as haart is known to do, but if haart also increases likelyhood of some other cancers.... well we know they approved haart ... so i think it is a matter of degrees and statistics, if it is a one in a million thing sure they will approve,  ...   

 i think haart qualifies in relation to your phrase, but haart has been approved,   "if it is found that any of these gene therapies cause a significant increase in the risk of cancer they will never be approved as a treatment for humans."

here is latest haart and cancer studies... i have not had time to read them, any body find anything interesting let us know, or if you have personal experiences
http://scholar.google.com/scholar?as_q=haart+cancer&num=100&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=&as_publication=&as_ylo=2005&as_yhi=2007&as_allsubj=all&hl=en&lr=

the other thing is ... the things humans do every day... smoke, over eat, drink heavy, not sleep, stress... cause so much un health and cancer (sun exposure etc), that it is hard to talk about this issue... esp. with gay men who for some reason contineu to smoke so much

one other thought...   gene therapy is very lazer specific very nano, very focused, and the ... well lets just hope tthat it works...

the friends i know who were administered gene therapy and seems successful had no problems yet

so...

Offline hahaha

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Re: Gene therapy results due?
« Reply #40 on: March 21, 2007, 11:24:03 PM »
I have a question:
If I took gene therapy, can I also take other vaccine as well?
For example, if I take Virxsys, can I, afterwards, take OZ1 or other vaccine like the emory univ rA5?
 
Aug 9, 2006 Get infected in Japan #$%^*
Oct 2006 CD4 239
Nov 2006 CD4 299 VL 60,000
Dec 1, Sustiva, Ziagan and 3TC
Jan 07, CD4 400

Offline MitchMiller

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Re: Gene therapy results due?
« Reply #41 on: March 21, 2007, 11:35:47 PM »
If you take a sample of the exclusion criteria for some vaccine clinical trials, you will notice they typically exclude anyone that has been in another vaccine trial.  It makes sense because it would make it difficult to determine if their vaccine alone, or in combination with another vaccine that the subject had previously used, was responsible for any significant therapeutic responses.  That's why I would recommend waiting for a phase three trial.  That way you'll have much more data to at least allow you to make a more educated guess as to whether a vaccine or therapeutic treatment might really work and have no serious side effects. 
I guess you could also be unethical and just lie and say you were never in a trial before.... and hope they couldn't figure it out... but by doing so, you might also expose yourself to an unknown risk... so I wouldn't advise it.

Offline hahaha

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Re: Gene therapy results due?
« Reply #42 on: March 22, 2007, 11:44:07 PM »
If you take a sample of the exclusion criteria for some vaccine clinical trials, you will notice they typically exclude anyone that has been in another vaccine trial.  It makes sense because it would make it difficult to determine if their vaccine alone, or in combination with another vaccine that the subject had previously used, was responsible for any significant therapeutic responses.  That's why I would recommend waiting for a phase three trial.  That way you'll have much more data to at least allow you to make a more educated guess as to whether a vaccine or therapeutic treatment might really work and have no serious side effects. 
I guess you could also be unethical and just lie and say you were never in a trial before.... and hope they couldn't figure it out... but by doing so, you might also expose yourself to an unknown risk... so I wouldn't advise it.

Dear Mitch,
Thanks, but i guess we have misunderstanding.
The reason I ask this question is, if I am dying, and if there is a vaccine that is not 100% cure comes up.  I have no choice but using it.  But then, I might recover a little bit.   After a next few year, a "real" or a "better" vaccine come up, will my body be able to take another vaccine without "conflict", or the two vaccines will "boost" each other? 

 Let me raise an example, if you have vaccine A that produce antibody A, then vaccine B probably won't work on you because you have antibody A already.  Therefore, your body won't produce antibody B anymore.  That is what I am worry about:  I can only vaccine "once", even if that is not the best one.

Aug 9, 2006 Get infected in Japan #$%^*
Oct 2006 CD4 239
Nov 2006 CD4 299 VL 60,000
Dec 1, Sustiva, Ziagan and 3TC
Jan 07, CD4 400

Offline bimazek

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Re: Gene therapy results due?
« Reply #43 on: March 23, 2007, 09:54:52 PM »

I would not worry about that at all, from my understanding of science, you could get many vaccines and they should not interfeer with each other in any way.  It is like all the nutrients and molecules in food, the body does a great job of figuring out what should go where, what the vaccines do and many of the new ones are very advanced, is they take a shape a part of a virus, but really just a molecular shape and they present that shape to the immune system, but just like there are thousands of shapes on a car, there are lots of shapes on a virus, so they should not interfer, you get a flu vac every year slightly different and no one worries...   perhaps if it is a trial they will want you not to be getting different ones, but remember it is your life and health, a vaccine trial may be good, try it why not

also about gene therapy and cancer, i think that it is not such a big issue, because they would not be doing human trials if they were so worried about it, for example at ucla the guy who is doing gene therapy trials for hiv i was told, matsuhito or something, he is the top cancer researcher so he has deep intense understanding of the body immune system cancer etc... more so than most on planet, and he came up with idea as a good one, also they must have done many mouse, chimp etc studies first

this has been worked on day by day for 25 years or more

so i am optimistic


Offline milker

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Re: Gene therapy results due?
« Reply #44 on: March 23, 2007, 10:16:44 PM »
Gene therapy has nothing to do with vaccines. Vaccines are dead viruses that are injected in low quantity so that the body reacts and trains itself in generating antibodies so that if you are infected with a real virus the body will be ready to attack.

In this case, the gene therapy modifies the immune system so that it has an attack sequence ready in case you get infected by the virus.

The way it works is to take a sample of your blood, extract the cells that will receive the gene therapy, and inject an enzyme that will modify the cell's DNA so that it has a sequence that "fortifies" it in case of an infection by HIV.

Then those cells are injected back in your body, and the hope is that they will replicate with this stronger wall against HIV.

I am NOT a doctor, so I cannot possibly give you a definitive answer about mixing vaccines and gene therapy, but they are completely different, that's all I can say.

Milker.
mid-dec: stupid ass
mid-jan: seroconversion
mid-feb: poz
mar 07: cd4 432 (35%) vl 54000
may 07: cd4 399 (28%) vl 27760
jul 07: cd4 403 (26%) vl 99241
oct 07: cd4 353 (24%) vl 29993
jan 08: cd4 332 (26%) vl 33308
mar 08: cd4 392 (23%) vl 75548
jun 08: cd4 325 (27%) vl 45880
oct 08: cd4 197 (20%) vl 154000 <== aids diagnosis
nov 2 08 start Atripla
nov 30 08: cd4 478 (23%) vl 1880 !!!!!!!!!!!!!!!!!!!!!!!!!!
feb 19 09: cd4 398 (24%) vl 430 getting there!
apr 23 09: cd4 604 (29%) vl 50 woohoo :D :D
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Offline bear60

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Re: Gene therapy results due?
« Reply #45 on: March 25, 2007, 05:27:15 PM »
I understand that gene therapy is dangerous and still in experimental phases.::::::

Gene Therapy Experiment Called "Crazy"

Tue, 19 Aug 2003

The New York Times reports about yet another example of the 'Cowboy' approach to medical research. Doctors who founded Neurologix, a private company that is paying for New York-Presbyterian Hospital to test the safety of a radical experimental approach to treat Parkinson's disease, have inserted live virus into the brain of a patient suffering from Parkinson's, in the hope that the virus will carry gene therapy into brain cells to stop tremors.

Senior scientists around the country, however, question the ethics of this high risk, uncontrollable experiment in human beings that is being conducted without adequate safety data. Dr. Howard Federoff, director of the Center for Aging at the Univ. of Rochester, noted: "As a careful and very rigorous person approaching clinical trials, I'd like to see a great deal more data in a nonhuman primate model that the treatment is efficacious and very safe."

Among the serious risks involved in inserting a virus into brain cells, is that the virus' movement and effect in the brain are uncontrollable. Critics point out that once the virus is in the brain, there is no way to get it out or turn it off. Dr. Howard Federoff, said animal studies indicate the virus can spread from nerve to nerve.

Dr. Inder Verma, a gene therapy researcher at the Salk Institute, in San Diego, and past president of the American Society of Gene Therapy, noted another potential danger, which is that "the virus could spread to other areas of the brain, wreaking destruction."

Dr. Walter Olanow, chairman of neurology at Mount Sinai School of Medicine, told the Times "The danger is that if you inhibit too much you can induce wild, flinging movements which people have been reported to die from."

Dr. Olanow said unequivocally: "This is a crazy experiment."
Poz Bear Type in Philadelphia

Offline bmancanfly

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Re: Gene therapy results due?
« Reply #46 on: April 09, 2007, 09:49:21 AM »
I'm about to have a Shirley Maclaine in "Terms of Endearment" moment about the trial results for this study.  We were promised the rusults by Feb '07 and now it's April and still no word!!!?  This seemed so promising and then nothing.  How could the study results, and the participants have disappeared without a trace.

Anyone heard anything?
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline Jake72

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Re: Gene therapy results due?
« Reply #47 on: April 09, 2007, 11:39:32 AM »
I've actually been wondering the same thing.  I've noticed a trend in HIV research.  All too often we hear about some promising potential breakthrough.  Then it enters a clinical trial and-as if by magic-it vanishes from the face of the earth.  Even if it's bad news, it should at least be disclosed. 

I'm curious about the fate of this trial and what's new (if anything) with the much-hyped Ensoli vaccine trials in Italy and Africa...and with the dendritic cell stuff.   Viropro was supposed to launch its dendritic cell vaccine trials in Canada with a goal to getting something on the market by 2010 (!).  Dr. Julio Montaner, a respected name in HIV/AIDS research and treatment in Canada, was supposedly involved with the plans   Now there isn't even a reference to the vaccine's existence on the Viropro website.         

They say 'no news is good news,' but I don't know....

Offline NYCguy

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Re: Gene therapy results due?
« Reply #48 on: April 09, 2007, 12:14:40 PM »
This is starting to piss me off too. And yes, the Ensoli trials sounded so promising - those lilachat postings made it sound like it was working beyond anyones expectations, yet now, nothing.  Also, wasn't there supposed to be a TAT oyi trial this year in Italy, based on the theory that women with natually occuring tat oyi in Gabon had spontaneously retroconverted?  Haven't heard a peep about that.

As for the gene therapy trial which we were supposed to hear about in FEBRUARY, didn't Bimazek have a friend or two at UCLA who were in this trial?  Any word from them about this?

Also re Canada - Dr. Young Kang was supposed to be starting a huge trial early in 2007 that he claimed might be a "cure" and I haven't heard anything else about this either.

I guess we're all in the same boat sitting around waiting...and popping pills in the meantime :)
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline NYCguy

  • Member
  • Posts: 180
Re: Gene therapy results due?
« Reply #49 on: April 10, 2007, 04:05:52 PM »
Interesting chart of current therapies, including gene, in the pipeline and what phases + who is sponsoring. came across it scanning for tibotec news. last updated in august:

http://www.aidsinfonyc.org/tag/science/immunePipelineTables.html
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

 


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