Dermavir Patch

[ElZorro]

from: http://www.genengnews.com/industry-updates/genetic-immunity-develops-unique-nanomedicine-formulation-for-dermavir-therapeutic-vaccine-for-hiv-aids/82977316/

“We have now also obtained Phase II data showing safety, immunogenicity and viral load reductions when DermaVir is used for initial treatment of HIV-infected individuals. This is the human proof of concept of our topical nanomedicine vaccine technology. It is our belief that DermaVir will become the first nanomedicine vaccine developed to reconstitute HIV-specific immunity with the potential to maintain the health of people living with HIV infection.”

This article also indicates that the company is going into Phase II/III human trials. Can anyone explain how long trials generally take and if there is a place to track what trials are being conducted and what their statuses are?

[leatherman]

according to this thread (with links to other threads and info) http://forums.poz.com/index.php?topic=31553.0 results from phase II won't be in until 2015

just click on the blue search button, and search for "dermavir" for more info.
dermavir has been discussed here for several yrs, since 06 or 07.

[ElZorro]

Leatherman

Do you know what the normal clinical trial progession is? I read a lot about phase I, II, III, etc, but don't really understand what that means or how one gauges where in the development cycle a protocol is. If phase III results are satisfactory, does the treatment get submitted for FDA approval or are there additional next steps? Also, when they refer to Phase II/III human trials does that mean there were also Phase II/III animal trials?

Sorry if this sounds like a stupid question, but I just don't get it...

[leatherman]

Do you know what the normal clinical trial progession is?
Sorry if this sounds like a stupid question

there are no stupid questions  (usually LOL)
however, I have no clue about that , so someone else will have to answer
(or you could try googling it up. that's what I'd do if I attempted to give you answer.) 

[Inchlingblue]

Do you know what the normal clinical trial progession is? I read a lot about phase I, II, III, etc, but don't really understand what that means or how one gauges where in the development cycle a protocol is. If phase III results are satisfactory, does the treatment get submitted for FDA approval or are there additional next steps? Also, when they refer to Phase II/III human trials does that mean there were also Phase II/III animal trials?

This thread has some info. on that:

http://forums.poz.com/index.php?topic=28494.0

[bmancanfly]

I'm not clear as to whether this will be used as an adjunct to HAART,  or a replacement for it.  Anyone know?

[ElZorro]

sounds to me like it's a replacement for HAART.  no?

[veritas]

It is a replacement for HAART.:

http://www.geneticimmunity.com/GI0401.html

Looks pretty promising!

v

[Pepino2]

I am so sceptical.  This company is a family business emanating out of Hungary (Juliana, Zolt and his Wife - all related and holding key management positions)

Why aren't the Big Pharma's in this space, or are they?

When a company has a final product displayed in the form of an immediatley marketable patch that pretends to be able to do away with ART, I get extremely sceptical.

Pepino2

[Hellraiser]

I am so sceptical.  This company is a family business emanating out of Hungary (Juliana, Zolt and his Wife - all related and holding key management positions)

Why aren't the Big Pharma's in this space, or are they?

When a company has a final product displayed in the form of an immediatley marketable patch that pretends to be able to do away with ART, I get extremely sceptical.

Pepino2

Well it's still 4 years away from being marketable right?  I mean it's got to go through some rigorous testing to make it to market yet, so time will tell.

[InOurLifetime]

The company released additional Phase II data on DermaVir during the recent International AIDS Conference in Vienna.

http://www.businesswire.com/news/home/20100719005463/en/Immunacia%E2%80%99s-Genetic-Immunity-Reports-Phase-II-Data

' In a randomized, placebo-controlled, dose-ranging Phase II study conducted in Hamburg, Germany, thirty-six HIV-infected individuals not yet taking antiretroviral drugs received one of three DermaVir doses or placebo every six weeks. “The treatments were very well-tolerated and CD4+ cell counts did not decrease.” explained the study’s Principle Investigator, Jan van Lunzen, MD of the University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit. “At 24 weeks, the individuals’ HIV viral loads were compared to their baseline values. A statistically significant reduction of 0.5 log10 copies/mL – a 70 percent reduction equivalent to that produced by several anti-HIV drugs – was seen in the cohort receiving 0.4 mg DermaVir vaccinations. Also in this group, HIV gag-specific precursor/memory T cells increased by 97 percent as the viral load decreased, a relationship not seen with the presently available drugs." '

[geobee]

Here's a PR on the Dermavir patch.  Honestly, I can't make heads or tails of it.  Here's the juicy part (below the link)

http://www.marketwire.com/press-release/Power-Dream-Ventures-Genetic-Immunity-Announces-Positive-Phase-II-Data-DermaVir-HIV-1425557.htm

In a randomized, placebo-controlled, dose-ranging Phase II study conducted in Hamburg, Germany, thirty-six HIV-infected individuals, not yet taking antiretroviral drugs, received one of three DermaVir doses, or the placebo, every six weeks. "The treatments were very well-tolerated and CD4+ cell counts did not decrease," explained the study's Principle Investigator, Jan van Lunzen, MD of the University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit. "At 24 weeks, the individuals' HIV viral loads were compared to their baseline values. A statistically significant reduction of 0.5 log10 copies/mL, a 70 percent reduction equivalent to that produced by several anti-HIV drugs, was seen in the cohort receiving 0.4 mg DermaVir vaccinations. Also in this group, HIV gag-specific precursor/memory T cells increased by 97 percent as the viral load decreased, a result not seen with antiretroviral drugs. Based upon our study the immune boosting and antiviral activity of DermaVir immunizations may provide a unique treatment approach for people with HIV/AIDS."