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Novel HIV Therapy Suffers Stunning Setback

June 12, 2008

In a stunning setback, Project Inform has learned Koronis Pharmaceuticals has stopped the only ongoing study of their experimental drug, KP-1461. This decision was based on unexpected results from lab tests and not on safety concerns. Those participating in these studies have been told of these developments.

The lab tests that led to this decision were required by the FDA and were essentially repeats of earlier work done by the company. The tests, called serial passage experiments, exposed HIV to different concentrations of the drug to try and force HIV to grow resistant to it. This helps doctors and researchers understand what changes HIV creates to become resistant. Earlier tests failed to force resistance to KP-1461, so the FDA required Koronis to repeat them until resistance emerged.

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See Also
More on HIV Medications
HIV Drugs in Development

Reader Comments:

Comment by: xfiles Mon., Dec. 8, 2008 at 2:25 pm EST
Dr. Becker resigned from the company.
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Comment by: Thisissoweird (Netherlands) Tue., Dec. 2, 2008 at 3:48 pm EST
Very weird indeed, mind you: its now december 2008. Not a single word of what the $#% is going on. Curioser and curioser. So whatever happened to this doctor Becker? Or is this all a big hoax?
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Comment by: J (Maryland) Sun., Aug. 31, 2008 at 10:38 pm EDT
I wonder if it had to do with money. As always.
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Comment by: Mon., Aug. 25, 2008 at 9:02 am EDT
All we know about kp-1461, failure or not, comes from Paul Dalton's first report. If you read the Paul Dalton blog you can find a following post where it's written that koronis pharma will go, very likely, ahead with the clinical trial of kp-1461. Probably there is still hope that the VDA could really work.
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Comment by: Very odd! Sun., Aug. 17, 2008 at 7:14 am EDT
I wonder what's really happened here, why did earlier studies prove to be effective & now all of a sudden there's no effect whatsoever! All those years of preperation & trials with zero outcome. I'm trying not to feel too negative about this, but I guess millions of other HIV infected individuals across the world will have had their hopes pinned on this one - I guess it proves that HIV is a long way off being eradicated & we'll just have to learn to accept that.
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Comment by: vexed Fri., Aug. 1, 2008 at 12:50 pm EDT
i'm very encouraged by the thesis of terminal mutagenesis. however, i am also wondering how Koronis got this far in their research. I am still very hopeful that this will be the silver bullet. there are so many people counting on a cure like this. I am very hopeful that Koronis will not suffer a huge backlash, but instead will find out what went wrong
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Comment by: obama for president Wed., Jul. 9, 2008 at 7:55 am EDT
I agree absolutely that is a huge vexing mystery.
Koronispharma has stopped the trial but on the web site of clinicaltrial the trial is still ongoing. WHY?..
It is hard to believe that Koronispharma had presented false test lab result ( 14 serial passages that extinguish the virus ), it is hard to believe that FDA permited to start a clinical trial on humans - 1a and 1b- without to check exactly what f..k a hell is this experimental new approach and drugs.
It is hard to believe that they have waited nearly the end of phase 2 to find out that even in vitro ( if this is true..) there is no anti hiv activity.

A HUGE VEXING MYSTERY.

It seems a thriller movie
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Comment by: T. Wed., Jul. 2, 2008 at 9:47 pm EDT
BIG disappointment, I really thought this was the one.
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