New drug Nov-205 drug

[jboyhk]

It says here they were starting clinical trials is Sep 06. Anybody know anything about it? It seems to be already approved in Russia.

NOV-205, Hepatitis

NOV-205 is being developed to treat chronic hepatitis C in the U.S. NOV-205 acts as a hepatoprotective agent with immunomodulating and antiinflammatory properties. The FDA accepted Novelos' Investigational New Drug Application (IND) for NOV-205. The initial U.S.-based Phase 1b trial will evaluate NOV-205 as monotherapy for chronic hepatitis C genotype 1 patients who have failed pegylated interferon plus ribavirin therapy. The trial commenced in September 2006.

NOV-205 is approved for use in the Russian Federation under the trade name Molixan

[chcnme]

I can't see notes on this thread anymore.  I see where HR has said something here,  but I can't see the note (or any notes)  The only thing I see is the first note.  I have refreshed the browser, gone out and come back in, and I still cant see anything but the original note.  

HR - if you see this note (if it makes it on the forum) and if you have time to respond) can you please explain to me "viral variants" (or viral load increases) and the significance of "drug resistance". I have tried to figure this out by reading notes on MEdHelp (such as in the Alina thread and several others), but I'm still unclear as to what it means.

For example, on the VX-950 study report, it says:

"findings suggest that combination telaprevir treatment with peginterferon alfa-2a *may* prevent the development of clinically significant resistance to HCV protease inhibitors in treatment-naive patients."

On the HCV 796 study report, it says:  

The speaker addressed the fact that peak viral load reduction of -1.4 log occurred on day 4 but viral load decline started to increase. The issue of drug resistance was discussed by the speaker as a possible reason and said that the resistance testing results analysis is ongoing and will be presented later this year at another conference.

http://www.natap.org/2006/DDW/DDW_18.htm

Question:  I have been offered the trial with HCV 796.  I don't really like the looks of it, much, and I'm also wondering if I did say yes to it - could I be setting myself up for "drug resistance" if I'm one whose viral load goes up and keeps going up (and I'm taken off the HCV 796?)   If that DID happen, would I possibly then be resistance to all polymerase inhibitors?

Sorry if I sound so *dumb* on this  (I can barely figure out how to ask the question), but I have had concerns about drug resistance for a few months now.   Thanks if you have time and understand what I'm asking  (or if anyone has time and understands what I'm asking.) I'd appreciate any input.

And another question (for anyone).  Has anyone out there heard that HCV 796 has already had a Phase II that didn't go well as far as following protocol?  

Here is the Phase II that is recruiting now, but I can't find any previous Phase II studies.  

http://www.clinicaltrials.gov/ct/show/NCT00367887?order=1

Thanks.

[chcnme]

d*** doctors!  d**** research centers.  I'm sorry - it has stopped snowing, and I guess I'm just in a bad mood  (thank God for the laughter I get off Med Help :)  

Yeah... let's invade Russia!  

[Imagine]

Molotov cocktail?

Sure sounds too good to believe!

1. Monotherapy
2. 1 to 2 months tx.
3. Apparently no sx's.

So that

[orleans]

YEAH! Bring it on, just in time!

[Tallahassee]

I'm getting very excited about this drug (Glutoxim & Monixan)! Basically, group of Russian scientists was working on its development last decade. Unscientific description of this product: basically combination of modified amino acids (building blocks of protein) for "immunomodulation or immune stimulation".  It ultimately increases Th1/Th2 response (HR was explaining this well in prior threads) and shifts it in right direction.  Production of Interleukins (sp?), WBC, RBC, etc. is increased...  So, the possibilities of this product application are endless!

Russian company

[wyntre9]

My Primary care Dr. is from Russia.  I'm going to run these sites by him.

Thanks for the info.