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Author Topic: gene therapy virysis/ where to post ?? move to  (Read 10977 times)

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Offline powerpuff

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gene therapy virysis/ where to post ?? move to
« on: February 07, 2008, 06:22:37 PM »
today on philly news   feb7 2008
announced virysis trials doing well at controlling viral loads as an alternative option for treatment experienced/ doing trials o 58 hiv possitive anyone know of this still going on and when this will be continueing... anyone here from apple boy if he knows this was a new post this year so trials must be continueing.

Offline thunter34

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Re: gene therapy virysis/ where to post ?? move to
« Reply #1 on: February 07, 2008, 06:36:36 PM »
So, puff...I see you're posting all over the place again.  Never did get that confirmation test or counts, did you?
AIDS isn't for sissies.

Offline MitchMiller

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Re: gene therapy virysis/ where to post ?? move to
« Reply #2 on: February 08, 2008, 12:59:26 AM »
Here's the full article.  Note the projected price... better start saving your pennies now...

Gene therapy shows promise for HIV

By Marie McCullough

INQUIRER STAFF WRITER

For the first time, researchers have slowed and possibly stopped the AIDS virus from reproducing in patients by using a gene therapy that tricks it into self-destructing.

The results, announced Wednesday by Virxsys Corp., are a victory for the biotech start-up in Gaithersburg, Md., and for its collaborators at the University of Pennsylvania.

"The buzzword in the field is viral 'fitness,' meaning how well the virus can replicate," said Gary McGarrity, executive vice president for scientific affairs at Virxsys.

"In eight of the nine patient samples we studied, we see diminished HIV fitness up to two years after treatment."

That raises the hope that even if medical science cannot come up with the Holy Grail of AIDS research - a vaccine to prevent HIV infection - patients may be able to keep HIV under control, perhaps without relying on current drug cocktails, which are both toxic and extremely expensive.

"I think the Virxsys report is very important," said John Rossi, a molecular biologist at the City of Hope in California, who is also working on a gene therapy treatment for HIV.

"A lot of HIV patients are over 60 now and they're suffering the consequences of these toxic drugs. This shows there are alternatives."

The new report is also a sign that gene therapy may finally be a viable approach after 20 years of missteps and controversy - notably the 1999 death of Arizona teenager Jesse Gelsinger in an unrelated Penn gene therapy experiment.

"I think the field is really starting to accelerate," said physician Carl June, who leads the Penn team that is collaborating with Vrxsys. "There was so much frustration for years. But now there are new breakthroughs."

The gene therapy, called VRX496, is still in early human testing intended to demonstrate safety and determine the best dosages. Of the 54 patients who have been treated so far, none have experienced serious side effects, and many have seen clinical signs of effectiveness - their HIV viral loads have fallen and their supply of infection fighting T-cells has grown.

A Penn patient, one of the first and sickest to be treated, remains well more than four years later - even though conventional drugs had stopped working for him.

Yesterday's report, presented by Virxsys at a conference in Boston, looked deep into the molecular level of blood samples from nine randomly chosen patients to see whether the therapy was actually hitting its target.

VRX496 capitalizes on the fact that viruses are impotent on their own - but powerful inside a cell. That is the only place they can replicate, by hijacking the host's molecular machinery. HIV seizes control by splicing its own genes into the DNA of infection-fighting T cells, the backbone of the immune system.

The genetic wizardry involved in outwitting HIV is complex. First, the researchers remove T cells from an HIV patient and insert a gene into the cells that stops the AIDS virus from reproducing. Then, using Penn's patented technology, the T cells are multiplied a hundredfold and put back into the patient.

The vehicle, or "vector," that is used to insert this protective gene into the T cells is novel in itself: a disarmed version of HIV.

The protective gene carries instructions that eliminate the AIDS virus' ability to wrap its DNA in an envelope. So when HIV invades the cell, it steals this envelope-making gene, breaks out - and then finds itself unable to make the armor it needs to invade more cells.

The latest study also found that the protective gene is a double-whammy for HIV. The virus tries to simply delete the gene - its favorite mutating tactic for becoming resistant to conventional drugs - but that, too, reduces its reproductive "fitness." (It gets "wimpy," to use June's word.)

The researchers found that the nine patients' blood samples were loaded with HIV, most of it having mutated into harmless forms.

"For HIV to mutate around our treatment, it has to commit suicide," said McGarrity, the Vrxsys executive.

If the gene therapy becomes an approved treatment, still years away, the estimated cost would be $130,000, said Riku Rautsola, Virxsys' chief executive officer. While that's a hefty sum, the lifetime cost for conventional HIV-fighting drugs is about $700,000.

"We hope [VRX496] will become a frontline therapy once we have proven the impact is durable," Rautsola said. "This would clearly be better in terms of quality of life for the patients."

Offline ronaldinho

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Re: gene therapy virysis/ where to post ?? move to
« Reply #3 on: February 08, 2008, 07:19:55 AM »
Here's the full article.  Note the projected price... better start saving your pennies now...



I think they are refering to the cost of the treatment during a lifetime.Cheaper than ARVs , according to their estimates. Is has got to be this..otherwise, who would be able to afford a downpayment of $130.000??
« Last Edit: February 08, 2008, 07:22:14 AM by ronaldinho »

Offline John2038

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Re: gene therapy virysis/ where to post ?? move to
« Reply #4 on: February 08, 2008, 11:01:10 AM »
Hi,

this is a so beautiful news that I'd like just to add few more details:

Other, similar methods have been investigated for the treatment of HIV, but VIRxSYS says that its approach seems superior to what has come before. "Unlike other viral vectors, lentiviral vectors appear to sustain expression of the delivered genes of interest for a longer period of time," the release said.

Continued the release, "Their safety profiles are currently being evaluated in clinical trials."

Dr. Riku Rautsola, the president and CEO of VIRxSYS, said, "These results are everything weve been hoping for."

Added Rautsola, "VRX496 is a remarkably promising treatment for HIV. We are very excited about what we are seeing so far in our trials and are confident that these results will continue into Phase 3."

The VIRxSYS results were presented at CROI on Tuesday, February 5th from 1-4 P


Full text: http://www.edgeboston.com/index.php?ch=news&sc=glbt&sc2=news&sc3=&id=55960



How VRX496 is administered




Video
http://www.virxsys.com/pages/human-therapies/first-clinical-application/how-vrx496-works.php

CROI 2008
http://www.retroconference.org

Offline powerpuff

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Re: gene therapy virysis/ where to post ?? move to
« Reply #5 on: February 08, 2008, 03:40:13 PM »
Thanks guys!!!  ;D ;D ;D you found it. it truly sounds promising. i guess it will be a few more years of trials.to see how long it works for. unfortunately i live in canada it might take longer i believe it also means this would be more cost effective over ARVs for those resistant and less toxic overall. i cant imagine yet a machine hooked up to every hospital. but it sure would be cool if it was...

Offline thunter34

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Re: gene therapy virysis/ where to post ?? move to
« Reply #6 on: February 08, 2008, 05:37:04 PM »
Thanks guys!!!  ;D ;D ;D you found it. it truly sounds promising. i guess it will be a few more years of trials.to see how long it works for. unfortunately i live in canada it might take longer i believe it also means this would be more cost effective over ARVs for those resistant and less toxic overall. i cant imagine yet a machine hooked up to every hospital. but it sure would be cool if it was...

So I guess that means "No"?
AIDS isn't for sissies.

Offline thunter34

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Re: gene therapy virysis/ where to post ?? move to
« Reply #7 on: February 08, 2008, 05:50:39 PM »
Puff,

Quote Tim Horn:

Quote
At this stage of the game, I'm going to lock this thread and ask that you only post messages in the "Am I Infected?" Forum, as this really isn't the place to discuss the uncertainties surrounding your potential exposure to HIV (or HCV) and the next steps you should be taking to get to the bottom of this.

Thanks very much,

Tim Horn


AIDS isn't for sissies.

Online Miss Philicia

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Re: gene therapy virysis/ where to post ?? move to
« Reply #8 on: February 08, 2008, 07:49:14 PM »
Powerpuff, are you are or aren't you HIV + or not.  PLEASE READ THE WELCOME TREAD AND TIME HORN'S STATEMENT TO YOU.

I fail to see why you repeatedly ignore the admonitions of both Ann and Time Horn who are moderators?

Please reply.
"Ive slept with enough men to know that Im not gay"

Offline Patrick

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Re: gene therapy virysis/ where to post ?? move to
« Reply #9 on: February 09, 2008, 12:31:14 AM »
Wonderful, wonderful news.  The guy in the article who is doing well 4 years after treatment - wow!  That's amazing.  Truly innovative therapy.  Treatment is probably 5-7 years away yet, but that's ok.  If at that point the state of the art treatment for HIV is getting your blood tuned up once every 2 or 3 years and then that's IT - no side-effects, drug interactions, pills everyday etc...... then living with HIV will become a lot simpler and everyone's lifespan and quality of life will improve markedly.

God bless these scientists who come up with this exquisite and life-saving therapy.

Regarding the price, I cannot imagine insurance companies would be allowed to refuse to pay for this.  It may only be marginally more expensive than a couple of years of HAART.  And if it keeps those with HIV healthy and the claims for ancillary medical conditions down, then there may actually be a financial incentive for insurance companies to pay for this treatment.  In any case, I think the cost won't be much of an issue once the treatment has become the standard of care.
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Offline lonbjny

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Re: gene therapy virysis/ where to post ?? move to
« Reply #10 on: February 09, 2008, 10:53:24 AM »
Hi,

I love to hear about new potential therapies. Could somebody post if they have an indication of when Phase III starts, this is when it gets really interesting.

Thanks

Offline powerpuff

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Re: gene therapy virysis/ where to post ?? move to
« Reply #11 on: February 09, 2008, 01:34:29 PM »
This is silly why is thunter person  fighting me on posting on new medical breakthroughs, i am simplyly posting new medical breakthroughs. for the sole perpose of shareing knowege e  ALL persons Affected and infected in ;D including family and friends, and caregivers to share openly on this site. as stated above. i wish you well. :-\ thank you those who wrote to me thanking me on updating new medical news. i admit i am terrible at cut and paste and computers so bare with me.  Bless you! ;D

Offline thunter34

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Re: gene therapy virysis/ where to post ?? move to
« Reply #12 on: February 09, 2008, 02:29:33 PM »
This is silly why is thunter person  fighting me on posting on new medical breakthroughs

You're deliberately flouting the posting rules for this website and ignoring direct instructions from the moderators, that's why.
AIDS isn't for sissies.

Offline Tim Horn

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Re: gene therapy virysis/ where to post ?? move to
« Reply #13 on: February 09, 2008, 03:11:55 PM »
PP:

I've been busy getting content onto AIDSmeds in the wake of the recent Retrovirus conference in Boston. I wouldn't have even noticed this thread, started by you, if you hadn't reported yourself to the moderators.

PP, no more posting ANYWHERE on the site, other than in "Am I Infected?"  I'm serious -- next time (even in response to this message), it'll be a permanent ban.

What's really pissing me off is your inability to read, not only my warning to you, but also the simple, corteous request -- in the "Research News and Studies" Forum -- that messages drawing attention to a new discovery/research finding include a REFERENCE and LINK to the source of the information. What you're doing here isn't sharing information -- you're spamming the site.

Tim Horn
« Last Edit: February 09, 2008, 03:16:08 PM by Tim Horn »

Offline hahaha

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Re: gene therapy virysis/ where to post ?? move to
« Reply #14 on: February 10, 2008, 08:05:02 AM »
Don't know where to post this question, so put it here, if improper, feel free to move it to the proper forum, thanks.

Wondering if, only if, this Virxsys works, will the insurance pay for the treatment?  Does anyone have a clue about that?
Highly appreciate for the response.
Aug 9, 2006 Get infected in Japan #$%^*
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Jan 07, CD4 400

Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #15 on: March 17, 2008, 06:56:30 PM »
Anyone have news on when Phase III trials start? I woud be interestd in the Amsterdam trials.
« Last Edit: March 17, 2008, 10:14:17 PM by Magnus »

Offline hahaha

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Re: gene therapy virysis/ where to post ?? move to
« Reply #16 on: March 18, 2008, 04:04:07 AM »
Just out of curiosity: If the gene therapy goes really smoothly, how long will it normally take for a phase II trial goes to phase III and being legally provided in the market?  two year?  three year?  or, another 10 year?

I JUST CAN'T WAIT TO GET RID OF MY MED!! >:(  In what kind of condition can FDA expedite the approval?

Unless waiting here........ 
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 J220

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Re: gene therapy virysis/ where to post ?? move to
« Reply #17 on: March 18, 2008, 04:19:03 PM »
Since things are moving fairly well, from what I've read, I would speculate that within 2 years we should know whether this will be FDA-approved or not. As far as insurance, I don't see why they wouldn't cover it, considering how expensive it is to currently supply a patients meds and treatment. A one-shot therapy that will keep a patient off meds for a substantial time period, if not permamently, will undoutedly appeal to insurance companies.
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Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #18 on: March 18, 2008, 04:23:10 PM »
Do you know where i could get information about the clinical trials J220?

Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #19 on: March 18, 2008, 07:35:31 PM »
Since things are moving fairly well, from what I've read, I would speculate that within 2 years we should know whether this will be FDA-approved or not. As far as insurance, I don't see why they wouldn't cover it, considering how expensive it is to currently supply a patients meds and treatment. A one-shot therapy that will keep a patient off meds for a substantial time period, if not permamently, will undoutedly appeal to insurance companies.

Two years? Isn't that awfully fast? How long do Phase 3 trials take? If it works, I'd love to see it available ASAP, of course, as would most of us.

I agree that insurance companies, ADAPs, and national health schemes would probably pay for it considering the long-term cost effectiveness. They might gasp a bit first, though (remember the freak-out over the price of T20?).   

Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #20 on: March 20, 2008, 12:35:26 PM »
I think the current Phase II trials end July '08. As someone mentioned earlier the info at CROI 2008 was an interim report.

I'm not sure how long Phase III trials take...anyone know?

I've emailed Virsyxsys for info regarding Phase II but have not received a reply yet.

Offline tash08

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Re: gene therapy virysis/ where to post ?? move to
« Reply #21 on: March 20, 2008, 03:44:04 PM »
Hey Magnus,

I'm glad to hear that you have decided to get in touch with Virxsys, hopefully they will get back to you soon. Let us know what they'll tell you.

It's always better to be proactive instead of waiting forever.  Good job ;)
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Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #22 on: March 20, 2008, 10:22:02 PM »
Thanks Tash!

 I'll defiantly let everyone know if they get back to me :)

Offline denniss

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Re: gene therapy virysis/ where to post ?? move to
« Reply #23 on: March 21, 2008, 10:09:19 PM »

The genetic wizardry involved in outwitting HIV is complex. First, the researchers remove T cells from an HIV patient and insert a gene into the cells that stops the AIDS virus from reproducing. Then, using Penn's patented technology, the T cells are multiplied a hundredfold and put back into the patient.

The vehicle, or "vector," that is used to insert this protective gene into the T cells is novel in itself: a disarmed version of HIV.

The protective gene carries instructions that eliminate the AIDS virus' ability to wrap its DNA in an envelope. So when HIV invades the cell, it steals this envelope-making gene, breaks out - and then finds itself unable to make the armor it needs to invade more cells.

The latest study also found that the protective gene is a double-whammy for HIV. The virus tries to simply delete the gene - its favorite mutating tactic for becoming resistant to conventional drugs - but that, too, reduces its reproductive "fitness." (It gets "wimpy," to use June's word.)


Sounds a bit like a method that is already being used in Africa! Its a bit of a controversy so I wouldnt want to get some pipo here all cheesed off.  So if you want to read about this, google "VANHIVAX". Even more interesting google "VANHIVAX Lipid Sciences". Hope Im not offending anyone.

Denniss


Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #24 on: April 01, 2008, 04:32:49 PM »
I think the current Phase II trials end July '08. As someone mentioned earlier the info at CROI 2008 was an interim report.

I'm not sure how long Phase III trials take...anyone know?

I've emailed Virsyxsys for info regarding Phase II but have not received a reply yet.

Hey Magnus-and everyone else,

Any replies about this? Am curious to see where this is going...

Take care,

Jake

Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #25 on: April 03, 2008, 12:20:07 PM »
No replies Jake!

Everyone interested should send them an email to find out more info then post here if they reply :D

Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #26 on: April 03, 2008, 05:04:20 PM »
No replies Jake!

Everyone interested should send them an email to find out more info then post here if they reply :D

Thanks for your reply, Magnus. That's a good idea! I've just written an e-mail to the company, and if/when I hear anything, I'll post it right away.


Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #27 on: April 11, 2008, 02:42:35 PM »
Well I haven't heard anything from  the company itself, but I did hear this from  the UPenn test center:

"There are no plans for phase lll trials here at Penn as far as I know. I am still screening and enrolling subjects into our current trial. However, after DSMB recommendations, the protocol is being amended. Participants will require a CD4 > 450, CD4 nadir > 300, and undetectable VL. There will be only 3 infusions in the amended protocol, as opposed to the 6 infused now."

Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #28 on: April 14, 2008, 01:26:40 PM »
Thats great you got a reply Jake- The company is very quiet!

 so Phase II is still going on at U. Penn ?

Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #29 on: April 14, 2008, 08:42:01 PM »
Yes, apparently so, and they'll still recruiting. There's also another site (in New York) that is conducting the trial. They don't seem to know when it will end. At least it is still going on. Let's hope for some speedy results!

Offline Magnus

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Re: gene therapy virysis/ where to post ?? move to
« Reply #30 on: April 14, 2008, 09:07:35 PM »
Well that's encouraging- So I suppose Phase III wont be planned till this phase wraps up.....

Can wait to see results either.....

Oh Jake- since you are in contact with U Penn, could you ask them if they accept people with non-B subtypes?

Thanks!
« Last Edit: April 14, 2008, 09:09:57 PM by Magnus »

Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #31 on: April 15, 2008, 12:42:06 AM »
Well that's encouraging- So I suppose Phase III wont be planned till this phase wraps up.....

Can wait to see results either.....

Oh Jake- since you are in contact with U Penn, could you ask them if they accept people with non-B subtypes?

Thanks!

Done! I'll let you know as soon as I hear something.

Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #32 on: April 16, 2008, 08:28:39 AM »
Hey Magnus (and everyone else),

Regarding the question of subtypes, here's the answer from UPenn:

"As long as they meet the criteria for the study, they can enter. I don't check HIV subtypes for entry."

I hope that this helps!

Cheers,

Jake

Offline AtomicA

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Re: gene therapy virysis/ where to post ?? move to
« Reply #33 on: April 22, 2008, 05:46:39 PM »
Well I haven't heard anything from  the company itself, but I did hear this from  the UPenn test center:

"There are no plans for phase lll trials here at Penn as far as I know. I am still screening and enrolling subjects into our current trial. However, after DSMB recommendations, the protocol is being amended. Participants will require a CD4 > 450, CD4 nadir > 300, and undetectable VL. There will be only 3 infusions in the amended protocol, as opposed to the 6 infused now."


what does CD4 nadir mean? does that mean never been below that level? Do you think they would accept people from Canada if they could get themselves down there?

Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #34 on: April 22, 2008, 08:28:13 PM »
Yes, nadir is the lowest CD4 count ever. I think they would consider Canadian participants. I live in Canada, and when I was inquiring about being part of a phase II study, this didn't seem to be an issue. I decided not to do it because it seems rather intensive (frequent monitoring, etc.), so the commute from my home to one of the facilities would have been rather inconvenient (and expensive).

Offline appleboy

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Re: gene therapy virysis/ where to post ?? move to
« Reply #35 on: April 22, 2008, 08:56:52 PM »
Yes Nadir is the lowest CD4 count you have ever had.  This is what kept me from getting into the trial as they changed it right as I was about to enter again.  This is indeed some good sounding news!  I would think if the trials go without any major hiccups then it should fall under the FDA's accelerated program.  As far as the questions I have seen about insurance covering this I honestly don't see why not if it makes a poz person's claims go down.  I also would find it hard to believe that an insurance company would decline to cover an FDA approved drug.  Now that is not to say they would not.  You know how insurance companies are.  It could be hard at first then I would say it would become more accessible with time. 
Cheers
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Offline Jake72

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Re: gene therapy virysis/ where to post ?? move to
« Reply #36 on: April 23, 2008, 11:05:24 AM »
I just received this reply from the company itself regarding Phase III trials:

"The best thing is to keep your eyes on our web pages for developments"

So it's not much info, just a "stay tuned" answer. Still it's better than an "I'm sorry..."

Take care,

Jake

Offline bimazek

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Re: gene therapy virysis/ where to post ?? move to
« Reply #37 on: April 26, 2008, 08:01:18 PM »
has anyone seen a complete list of all gene therapies that are being tried or have been tried on hiv
there must be a dozen by now

 


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