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Medical Forum / Diseases and Disorders / Hepatitis / October 2005

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Hum.  Mono-Therapy  drug approved in Russia

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smith21347@msn.com - 10 Oct 2005 15:14 GMT
NOV-205, Hepatitis

NOV-205 is being developed to treat chronic hepatitis C in the U.S.
NOV-205 is designed to act as a hepatoprotective agent with
immunomodulating and antiviral activity.
NOV-205 is approved for use in the Russian Federation under the trade
name MOLIXAN®. Commercialization of NOV-205 is commencing in Russia.

Clinical studies in 178 Russian hepatitis patients have demonstrated
that NOV-205 is effective and safe. When used as mono-therapy for one
month in hepatitis B and for two months in hepatitis C, NOV-205 has
been shown to greatly reduce/eliminate viral loads and to vastly
improve liver function.

Overall, more than 700 Russian hepatitis patients have been treated
successfully with NOV-205. Preclinical studies also support NOV-205's
anti-viral and hepatoprotective effects.

While based on oxidized glutathione, NOV-205 is stabilized differently
than NOV-002 and is a separate chemical entity from NOV-002.

Novelos plans to file an IND with the FDA for NOV-205 as a mono-therapy
for chronic hepatitis C in 2005, and then initiate U.S.-based clinical
trials.

                                              RON
Thomas Wagner - 10 Oct 2005 16:43 GMT
>NOV-205, Hepatitis
>
[quoted text clipped - 3 lines]
>NOV-205 is approved for use in the Russian Federation under the trade
>name MOLIXAN®. Commercialization of NOV-205 is commencing in Russia.

Sounds intriguing, but the info seems a bit spotty - what exactly does
it do, does it reduce or eliminate the virus? How do they define
"successful" treatment? Since it's apparently not much more than
glutathione modified for better bioavailability, isn't it just a
hepaprotective agent (not that that's anything to scoff at, but it's not
a cure)?

From other info about NOV-205
(http://www.cohenresearch.com/reports/nvlt_09-22-05.pdf)
it seems that it does have a clearly positive effect on LFTs, and that
it apparently can reduce viral load. However, the published data from a
clinical trial of just 15 patients (!) shows only a 1-month followup,
and a return to detectable virus in 30% of those that had an
undetectable virus at EOT (40%), which makes it likely that this is a
temporary effect.

Still, it certainly is interesting to watch, especially since it's
unlikely to have significant side effects, so it might be beneficial as
an adjunct to standard treatment, and possibly helpful for those who
can't treat or relapsed. But a LOT more data is needed, and anecdotal
data just doesn't cut it.

Thomas
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smith21347@msn.com - 10 Oct 2005 17:23 GMT
True the info is spotty. However the fact that the russians have
approved this makes it well worth watching.  They have treated 700
people and it won't take long to see how these people fare.

                              Ron
kjoh - 10 Oct 2005 18:53 GMT
Hi Gang:  Here are some links for those who want to read more about
glutathione.  Its not known to be a cure. It's not an herb, its an
antioxidant/peptide/coenzyme/hormone synthesized by healthy livers.  It,
and its precursor compounds, are available OTC.  It acts in detoxification
and may be antiviral.  In my opinion (which differs from other *experts*)
it in NOT something I would take much of while on tx because it probably
interfers with drug uptake in some way that hasn't been *factored in* by
the people who invent interferon doses.    Stephen Harrod Buhner (see
Amazon.com), who is my personal alternative med guru, a *fringe* thinker,
and  a certified genius with hep c, says to take the precursor
n-acetylcysteine, which is an antioxidant nutrient, unless you have severe
liver damage, then take glutathione.  The doses he recommends in his book
strike me as too high,  though.  Consult your physician, who probably
doesn't know anything about it :)   kj

From lef.org:
Glutathione
Glutathione, a molecule composed of glycine, glutamate, and cysteine, is
key to the regulation of cellular activity. Depletion of glutathione below
a certain level causes cell death. Glutathione is synthesized and highly
concentrated in the liver where it plays a key role in the cytochrome P450
detoxification system. It protects cells by quenching free radicals; in its
reduced form, glutathione has potent antioxidant action. Glutathione is a
major antioxidant made by the body and is important in the manufacture of
lymphocytes.161 Cytokine production in response to inflammatory stimuli
depends on the ability of the body to produce glutathione.162 Attack by
free radicals depletes glutathione, and low levels of glutathione are
linked to many diseases. Aging alters glutathione status so that reduced
glutathione tends to be lower and oxidized glutathione rises.163
Malnutrition164 and alcoholism165 cause deficiencies of glutathione
precursors and consequently limits glutathione synthesis.166 There is a
relationship between liver damage and production of free radicals during
inflammatory processes. In CHC, liver damage is attributed to an imbalance
in the oxidation and reduction processes and to glutathione depletion.
Chronic inflammation provoked by the replication of HCV and might also
have a role.167 Monocyte glutathione is low in hepatitis C and altered
glutathione status is a feature of cirrhosis and nonalcoholic liver
disease.

Nutrients that Raise Glutathione Levels:
Glutathione stimulation is a primary immune-modulating mechanism. The
amino acid precursors to glutathione increase glutathione concentration in
relevant tissues and stimulate immunity.Taking supplementary glutathione
and its precursors, such as alpha-lipoic acid, N-acetyl-cysteine,
S-adenosyl-L-methionine, increases glutathione in the body.  From:
http://www.lef.org/protocols/prtcl-058c.shtml#glutath

Also, you can go to this site and paste in the title/authors below  
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

Oxidative stress in viral and alcoholic hepatitis Loguercio

Mitochondrial dysfunction in hepatitis C Korenaga
Analgesics and glutathione Lauterburg

Therapy of hepatitis C: other options  Bonkovsky

Glutathione depletion: its effects on other antioxidant systems and
hepatocellular damage Comporti

Interaction of alcohol with other drugs and nutrients. Implication for the
therapy of alcoholic liver disease Lieber
Thomas Wagner - 11 Oct 2005 01:49 GMT
>True the info is spotty. However the fact that the russians have
>approved this makes it well worth watching.  They have treated 700
>people and it won't take long to see how these people fare.

Unfortunately, an approval in Russia is not necessarily a sign of
quality. Given the widespread corruption in that country, and the
numerous medical scams (the latest was the stem cell scam that fooled
many people, including a few Heppers), caution is warranted. I don't
believe that meds undergo anywhere near the level of scrutiny before
approval as they do in the EU or the US. It also appears that there is
little if any followup on the 700 supposedly treated people, which
doesn't inspire confidence. It may just be a lack of published info, but
you'd expect the company to be a bit more forthcoming if they actually
had good data.

As kjoh has pointed out, glutathione is not exactly something new, and
indiscriminate use, especially during treatment, may be detrimental
instead of helpful. Anyone with HCV, whether on treatment or off, should
be VERY careful in jumping to conclusions based on spotty and possibly
manipulated data (the "anecdotal" data looks a bit suspicious). Once
more data is available from more reliable sources (such as clinical
trials in the US), things may be different. Or it may turn out to be a
lot of noise about nothing. We'll have to wait and see.

Thomas
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smith21347@msn.com - 11 Oct 2005 02:54 GMT
Yes
        Hard to judge anything comming from Russia. It figures there
would be a lot of corruption concerns. I don't have a clue.  All I know
for sure is they supply the space station.

                         Ron
 
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