Meds, Mind, Body & Benefits > Research News & Studies

KP 1461

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Dr.Strangelove:
Ah, thanks Skydrake, I wasn't aware of that thread, yet.

And there is also another thread here (as some of you are obviously aware).

Lets start with this comment from Tim:

--- Quote from: Tim Horn on May 24, 2011, 08:10:08 PM ---After an in-depth conversation with some of the Koronis folks, I'm no closer to understanding how KP-1461 will somehow achieve either a sterilizing or or functional cure, nor am I understanding any of the potential clinical benefits of this agent. The public relations surround this drug appears much more solid than the science.

--- End quote ---

They have been very busy spreading the word about their new approach and although they have very little scientific data, they don't shy away from using the 'C-word ('cure', not 'cuntwaffle'  ;) ). Which reputable pharmaceutical company does that?
Have a look at their website:
http://www.koronispharma.com
They have three fancy 3D animations about their 'revolutionary new HIV therapy' but there is little solid information there.
Check out the Testimonials page. First of all, why would you have a testimonials page about a therapy that does not even exit??? Read the one comment that's on that page: "I have been reading about the new drug KP-1461 on your website...." apparently that's one random African woman what came across the Koronis website and is hoping for a breakthrough. Why would any pharma company put that on their website? My guess is they wanted a 'testimonials' page to look more credible.

Now check the actual page about KP-1461. Here, they explain how the drug is supposed to work. Scroll down you see the structural formula of KP-1461! Have you ever seen any pharma company post the structural formula of their drug in development on their website? I haven't. Anyone who's worked with a pharma company knows that they are extremely discreet about these kind of things; make people sign non-disclosure agreements and so on... So, this just doesn't add up.

Now for the science. As several people already pointed out in the other thread that I linked above, KP 1461 claims to be a path to a cure but the problem is that, while it may increase the mutation rate of the viral RNA, it does not affect the reservoirs. In the latent cells the viral genome (which unlike many other viruses is a single stranded RNA and therefore already has an intrinsic higher mutation rate) has been incorporated into the human genome of that cell (which is DNA). There is no way how KP 1461 can affect the viral DNA at this stage.
The thing is that we already have many drugs that successfully kill the free virus in the blood stream. Even if KP 1461 could kill the virions by accelerated mutation, the problem with the latency still exists. Several people have pointed that out in the thread I linked above but the Koronis guy avoids that question:

--- Quote from: Mark Fromhold on August 03, 2011, 05:10:48 PM ---Unfortunately, I'm unable to respond to each individual post
--- End quote ---
Also, see Tim's quote above. Even in an in-depth conversation with Koronis, they could not explain how this could possibly be a cure.

And now for the scientific publications. They link to several papers on their website. These are already a few years old. They've been published in reputable journals such as PNAS. They are legit. But they are just the basic research. They propose a new approach that needs to be investigated further.
Needless to say that none of these peer-reviewed publications suggest this might be a pathway to a cure of HIV.
Check out the review "Lethal mutagenesis of HIV with mutagenic nucleoside analogs" on that page. Even this publication that Koronis links to on their website points out in the last chapter 'Perspectives':

--- Quote ---Viral latency is a serious obstacle to conventional antiretroviral therapy and is likely to present similar barriers to clearance by lethal mutagenesis.
--- End quote ---
The authors suggests that this viral decay through mutagenesis approach, if it works out might help positive patients that are resistent to other retroviral meds. So, basically they say, if it works it will be just like a another drug against HIV.
These older publications about the basic science of increasing mutation rates by nucleotide-analogs where not done by Koronis itself but by universities. Koronis picked up this approach from there.
But Koronis has published, too: link  Or rather, they finded this study.
What's interesting is, that their study was published in the journal Plos One. Unlike pretty much every other peer reviewed journal out there Plos One has the policy to publish anything, no matter if the results are new, interesting or important for that field of science - as long as it's technically sound. (Here's NATURE mocking Plos One for that policy: "The beleaguered paper eventually found a home at PLoS ONE, a journal that publishes all “technically sound” papers, regardless of novelty.")
In practice, scientists first try to publish their research in reputable, high-impact journals first. When it gets rejected there because it is not interesting or important enough, they take it to Plos One. I'm not saying it is a crap journal but whenever you see a publication from that journal you should take it with a grain of salt and wonder 'why did they decide to publish it there?'. Especially so if it's "revolutionizing HIV therapy" as Koronis claims doing.
So what did the find in this short term study? From the abstract:

--- Quote --- Plasma viral loads were not reduced, and overall levels of viral mutation were not increased during this short-term study.
--- End quote ---
Err what? Well, no wonder they didn't get this published in one of the reputable HIV journals.

As you see, nothing in the Koronis story adds up. I don't have a smoking gun to prove it's a scam but there are plenty of red flags everywhere.

Oh damn, I wish I had seen this earlier. There is even an article here on the blogs of POZ.com about the whole case: link

--- Quote ---FDA had asked them to repeat a set of tests called, serial passage experiments where HIV is exposed to varying concentrations of a drug in order to force drug resistance to develop. This is a normal part of the drug development process. The FDA required Koronis to repeat their earlier serial passage experiment, because drug resistance did not emerge in the earlier experiments. The idea was to keep the experiment going until resistance did emerge.

It never emerged, because the experiments showed that the drug was having no affect whatsoever on HIV. They went and looked at the results from the US study, and found little to no evidence that the drug was working. Had the clinical data shown the drug working, it would have likely trumped the lab results.
--- End quote ---

Of course, I don't know what's really going on with that company. My guess is that  they picked up that lead with the nucleoside analogs which was developed at some university and looked promising at first. They were probably hoping to turn this into a new HIV drug. Halfway along the way, they realized that it's not working out the way they hoped. Despite of that they create a huge buzz to get some investors money to keep the whole thing going a little longer. And now might be the time where the whole thing is silently buried. I don't expect to hear (any breaking news) from them again. In fact, I would bet money on that.

What pissed me off is that they play with our hopes for a cure. They produce a few fancy 3D animations for their website that may impress a layman but have no substancial information, they do plenty of PR, they register a trademark for 'viral decay acceleration', they even create a Wikipedia article about 'viral decay acceleration', trying to give themselves some credibility, but they have little to no scientific data to back up any of their claims for 'Revolutionary HIV therapy' and 'cure'.

PS. Sorry for the long post.

Skydrake:

--- Quote from: Dr.Strangelove on October 18, 2012, 04:16:24 AM ---PS. Sorry for the long post.

--- End quote ---

Absolutely not. It is exhaustive and very interesting. Anyway (not wanting to be polite as you), the short version still could be "KP-1461 is scam"

buginme2:
So can we file this away in the same drawer as magic water?

I think you are dead on with the whole "cure talk" coming from a pharmaceutical.  You really need to have your ducks in a row before you start throwing around the c word.

Sangamo has also been throwing around the c word like crazy and to my knowledge they havent cured anyone.  Even if they "think" they may someday be on to somethi g seems pretty irresponsible to throwing around the word now. 

Skydrake:
But Sangamo showed plenty of data, very detailed, for every step it did.
It shareholders would not forgive a behaviur like Koronis pharma.
 

buginme2:

--- Quote from: Skydrake on October 18, 2012, 04:37:45 PM ---But Sangamo showed plenty of data, very detailed, for every step it did.
It shareholders would not forgive a behaviur like Koronis pharma.
 

--- End quote ---

Data for what?  Data for curing someone? Data for improving anyone's outcome? I think not.  Just because something looks promising?  If you are going to hold one company to a certain set of standards you really should hold them all to it.

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