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New potential AIDS treatment to soon enter human testing

Public Health AIDS 2009

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#1 sierraleone

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Posted 06 February 2009 - 11:20 AM

http://news.yahoo.co...UX2S6Ul2R6JhMgF

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California biotechnology company Sangamo BioSciences Inc. said on Monday it will start human testing of a new approach to treating the AIDS virus that involves deliberately damaging the patient's DNA.

The approach is based on research that has long shown that people with a certain mutation in a gene called CCR5 resist infection with the fatal and incurable virus.
...
The hope is these damaged cells will thrive and multiply and give the patient an immune system resistant to HIV.
...
The company said its phase I study is meant to look for safety only, and 12 patients with advanced HIV infection will be recruited.
...
In November, German researchers reported that a bone marrow transplant to replace the immune system of an HIV patient with leukemia not only treated his cancer, but appeared to have suppressed the AIDS virus as well. The transplant was from a donor who had the CCR5 mutation.

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#2 Balderdash

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Posted 06 February 2009 - 12:51 PM

Wow!  Go science!  :welldone:

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#3 BklnScott

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Posted 06 February 2009 - 12:56 PM

It's only a Phase I.  They have a compound they think "might someday be used to etc etc" -- nothing more.

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#4 QueenTiye

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Posted 06 February 2009 - 02:42 PM

^^It's still progress.  Very exciting progress.  Here's hoping it works.

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#5 BklnScott

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Posted 06 February 2009 - 03:42 PM

I don't mean to be a wet blanket, but I work in this industry, so I wouldn't call it progress.  

Let's say you have a compound that, in laboratory conditions, seems to do what you need it to do, i.e., kills or inhibits HIV or cancer or whatever.  Phase I (i.e., toxicology, pharmacokinetic, pharmacodynamic, etc) studies are then undertaken to determine what it does to living things.  It could kill you.  It could make you wish you were dead.  

This is why you might hear, from time to time, scientists who say "I can cure cancer -- in the lab."  Which is true.  But if they attempted to use their compound to cure the cancer in YOU, you'd die along with your tumor.

There are thousands and thousands of Phase I trials for everything you can imagine going on in the world at any given time, and the vast majority of them will never progress to Phase II... let alone III or IV.  

This article is basically a press release from a small company hoping to drum up some free publicity.  Again, don't mean to pee in anyone's cornflakes, but this isn't news.

Edited by BklnScott, 06 February 2009 - 03:43 PM.

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#6 Godeskian

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Posted 06 February 2009 - 03:44 PM

Here's hoping that this one becomes news then. :)

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#7 Mel

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Posted 06 February 2009 - 03:45 PM

View PostQueenTiye, on Feb 6 2009, 01:42 PM, said:

^^It's still progress.  Very exciting progress.  Here's hoping it works.

QT

It's an interesting idea.  There are lots and lots of ideas out there. You can't really call something that hasn't even started Phase I progress.  Many (most?) of the stuff that goes into early trials is either useless or in some unfortunate cases makes things even worse.  (See the Merck AIDS vaccine from a couple of years ago for an example.)

Edit:  Or what Scott said faster than me.

Edited by Mel, 06 February 2009 - 03:45 PM.


#8 sierraleone

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Posted 06 February 2009 - 09:13 PM

View PostBklnScott, on Feb 6 2009, 03:42 PM, said:

Let's say you have a compound that, in laboratory conditions, seems to do what you need it to do, i.e., kills or inhibits HIV or cancer or whatever.  Phase I (i.e., toxicology, pharmacokinetic, pharmacodynamic, etc) studies are then undertaken to determine what it does to living things.  It could kill you.  It could make you wish you were dead.

What is before Phase I? Because I can't imagine they can just inject people with anything.... Not saying that proves much, as the final proof is when its testing in human beings of course.
Rules for surviving an Autocracy:

Rule#1: Believe the Autocrat.
Rule#2: Do not be taken in by small signs of normality.
Rule#3: Institutions will not save you.
Rule#4: Be outraged.
Rule#5: Don't make compromises.
Rule#6: Remember the future.
- Masha Gessen
Source: http://www2.nybooks....r-survival.html

#9 BklnScott

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Posted 06 February 2009 - 09:49 PM

Well, no, you can't just inject anybody with anything.  There's a lot of preliminary work that happens before Phase I studies are undertaken... The study referenced above, for example, is safety only, not efficacy.  In other words, they're testing whether it's safe to use in people, not whether it does what they hope it will do.  There's a chance it will, of course, and that's why a dozen people with advanced HIV disease are being recruited, and why they are *willing* to undergo the protocol, despite the substantial risk to themselves: because they're looking for a miarcle.  

All that said, two points: first, adverse events up to and including death, happen to people undergoing experimental treatment all the time.  Second, phase I studies are not necessarily conducted on people at all.  They might be conducted on fruit flies ... or beagles.  ( :( )

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#10 sierraleone

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Posted 06 February 2009 - 09:57 PM

^ I was going to ask about animal testing. So what do they call all this preliminary work?

Shouldn't they call this "Phase One of Human Testing"?
Rules for surviving an Autocracy:

Rule#1: Believe the Autocrat.
Rule#2: Do not be taken in by small signs of normality.
Rule#3: Institutions will not save you.
Rule#4: Be outraged.
Rule#5: Don't make compromises.
Rule#6: Remember the future.
- Masha Gessen
Source: http://www2.nybooks....r-survival.html

#11 BklnScott

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Posted 06 February 2009 - 10:10 PM

Quote

So what do they call all this preliminary work?

"Discovery."  That sounds snarky, but it's really what they call it.  After discovery comes preclinical testing.

Edited by BklnScott, 06 February 2009 - 10:11 PM.

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#12 sierraleone

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Posted 06 February 2009 - 10:33 PM

View PostBklnScott, on Feb 6 2009, 10:10 PM, said:

Quote

So what do they call all this preliminary work?

"Discovery."  That sounds snarky, but it's really what they call it.  After discovery comes preclinical testing.

It doesn't, thought it made me giggle inside, maybe it seemed too right or obvious I dunno. Discovery makes perfect sense though, at point of discovery of some idea or principal that has applications in medicine (or technology,etc). Then preclinical testing. I'd imagine some of this is done in clinical environments though, just not ones with human test subjects in them ;)
Rules for surviving an Autocracy:

Rule#1: Believe the Autocrat.
Rule#2: Do not be taken in by small signs of normality.
Rule#3: Institutions will not save you.
Rule#4: Be outraged.
Rule#5: Don't make compromises.
Rule#6: Remember the future.
- Masha Gessen
Source: http://www2.nybooks....r-survival.html



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