Medical Forum / Diseases and Disorders / Hepatitis / October 2005
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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