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Apligen presentation online soon, including XMRV results of participants?

natasa778

Senior Member
Messages
1,774
http://www.earthtimes.org/articles/...he-rodman-healthcare-conference,1297660.shtml


Dr. Carter will also provide an interim report on retrospective analyses of patient samples from the completed Phase III trial of Ampligen in potential treatment of Chronic Fatigue Syndrome ("CFS") conducted in collaboration with the Whittemore Peterson Institute; these studies are expected to provide a new perspective on the design of a confirmatory Phase III study in this disorder. The samples are being analyzed for the presence of XMRV, a novel retrovirus, reported to be found in approximately two-thirds of CFS patients.

The presentation will be Webcast live. Listeners can access this broadcast through Hemispherx`s Website at http://www.hemispherx.net. The webcast will be available for 30 days following the presentation.
 
K

_Kim_

Guest
Monday, May 17th, at 11:30 AM BST; 6:30 AM EDT.

A bit early for me. I guess I'll be listening to the recorded broadcast. Thanks natasa.
 

julius

Watchoo lookin' at?
Messages
785
Location
Canada
This is just the bit where he talks about XMRV/CFS vs Ampligen.

Interim findings

"We've looked so far at several hundred specimens using a prespecified research plan. We can say based on the interim report, (we're still looking to do several hundred more samples) that the initial results indicate two things;


1) about two thirds of people with chronic fatige syndrome do have a very serious retrovirus, which is infectious, and which can only be found in a small percentage of normal people, but can be seen in people with hereditary prostatic cancer.

2)But the second and really exciting function here is that the patients who recieved ampligen and also had the novel retrovirus had a very dramatic benefit greater than that of patients who received ampligen and did not have this virus.

It's a tentative finding and as I said the study is ongoing, but as I said it does involve hundresds of subjects studied on a on a blinded basis in a predetermined research plan. We believe that we've tentatively identified a subset of patients
who are obviously in harms way. We know this because the incidence of suicide, cancer and sudden catastrophic cardiovascular events is very high in this population generally. Some of these events may be due to this virus, and those patients have a disproportional therapeutic response to ampligen versus patients on ampligen without the virus and versus placebo patients.

So we hope within the next several months to finish up on this analysis and to meet with the FDA to lay out a clinical plan for confirmatory study."
 

Lesley

Senior Member
Messages
188
Location
Southeastern US
This seems big to me. Several hundred studied, several hundred more planned. I think this shows us what pharmaceutical companies can do, and how busy WPI is behind the scenes.

During the webinar last week, Dr. Lapp mentioned that Hemispherx has blood samples from before and after treatment, and that it was interested in using to study XMRV.
 

Lesley

Senior Member
Messages
188
Location
Southeastern US
I think it's big because it is a possible treatment for XMRV, and because it also helps explain why some are helped by Ampligen and others aren't. Of course, it's unclear how long it will be until Ampligen is more readily available.

I think we need to get the title of this thread changed, because this deserves more attention than it is getting.
 

julius

Watchoo lookin' at?
Messages
785
Location
Canada
i'm pretty sure this presentation was aimed at investors or potential investors. With that in mind we have to understand that statements like " a very dramatic benefit greater than that of patients....." could have a very broad interpretation.

The fact that they claim to have found similar prevalence figures is encouraging; "about two thirds of people with chronic fatige syndrome do have a very serious retrovirus"
 

Lesley

Senior Member
Messages
188
Location
Southeastern US
i'm pretty sure this presentation was aimed at investors or potential investors. With that in mind we have to understand that statements like " a very dramatic benefit greater than that of patients....." could have a very broad interpretation.

On the other hand, there are consequences for making misleading statements to investors and anything he said would have been very carefully thought out with that in mind. Plus, I need some good news today. :Retro smile:
 

jewel

Senior Member
Messages
195
:) Just wanted to send a smile... The good study reports-- even if mid stream-- are trickling in. Even if Lerner's study is "less rigorous," the treatment approach may be helpful to those fighting multiple "regular" latent or persistent viral infections. And now, Dr. Klimas has some other biomarker possibilities, easier to use than the XMRV tests at present. Good Day OVERALL!!
 

julius

Watchoo lookin' at?
Messages
785
Location
Canada
On the other hand, there are consequences for making misleading statements to investors and anything he said would have been very carefully thought out with that in mind. Plus, I need some good news today. :Retro smile:

Oh, I was really happy with the report. Sorry that my post sounded pessimistic. Finding XMRV in 2/3 of pwcfs is really, really great news. It's actually the news I'm hoping for every morning when I turn on my computer and search this site.

I think the other part is also positive, but we have no idea how much improvement and how many improved. Words like 'dramatic' need to be understood in context.

But really great news overall.
 

Esther12

Senior Member
Messages
13,774
Isn't this pharmaceutical company getting sued for making misleading statements to investors already?

Whenever I read anything about them it's saying how poorly run they are. Hopefully the WPI can get some money from them for research, but I wouldn't expect much more than that.
 

dannybex

Senior Member
Messages
3,564
Location
Seattle
On the other hand, there are consequences for making misleading statements to investors and anything he said would have been very carefully thought out with that in mind. Plus, I need some good news today. :Retro smile:

Unfortunately, Carter has a well documented history of making misleading statements, especially suggesting to investors last spring (09) that Ampligen was close to FDA approval (within weeks), which sent the stock soaring to $4.50.

Months went by, excuses came and went, and as a result the stock price began to slip, and hovered around $2 by August/Sept '09. When the truth came out last November, the stock crashed to around 50 cents, and today is selling for 64 cents.

Hopefully he's learned from his mistakes.

???
 

Hope123

Senior Member
Messages
1,266
Isn't this pharmaceutical company getting sued for making misleading statements to investors already?

Whenever I read anything about them it's saying how poorly run they are. Hopefully the WPI can get some money from them for research, but I wouldn't expect much more than that.

Yup. I'm always concerned about anything Hemispherix puts out because I get the impression they make big announcements to the investment world (not the scientific world) but then they don't publish their results or talk about it at scientific conferences. What little I was able to get, which was not published and thus not confirmed, was that their last big trial (2005 initiated) only had very modest effects on people. (like a few extra minutes on the treadmill if I recall correctly) My impression was that the effects were measurable but not anything where it would affect someone signficantly. I also wonder if that 2/3 number was just cribbed from WPI vs. being real.

Now, if Sue is correct and they have new data subtyping by presence of XMRV showing good effect, I'm always willing to change my mind.

[Somedays, I want to believe the good press but the inner honest skeptic kicks in!]