Medical Forum / Diseases and Disorders / Hepatitis / May 2005
Different Type of Treatment
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smith21347@msn.com - 13 May 2005 18:20 GMT Energex System's Experimental Non-Pharmacological Treatment Shown to Reduce Viral Load in Hepatitis C Patients Monday March 28, 5:46 pm ET Company Plans HIV/AIDS Trial
EMERSON, N.J.--(BUSINESS WIRE)--March 28, 2005--Energex Systems, Inc. announced today that a clinical trial has established that its HemoModulator technology was safe and highly effective in reducing viral loads in trial participants inflicted with Hepatitis C. There were no reported adverse events related to the treatment. The trial was conducted under an Investigational Device Exemption (IDE) that was granted by the Federal Food and Drug Administration (FDA) in October, 2004. Energex's experimental treatment involves exposing a very small amount of an infected subjects blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Thomas Petrie, the developer of the technology and Director of Engineering at Energex Systems. "After exposure the treated blood is returned to the patient through the same portal it was drawn from. The result, we believe, is a stimulation of the immune system", said Petrie. The process takes 20-30 minutes.
In the trial, non-responders to Interferon/Ribaviran with a viral load of at least 100,000 IU or more were administered PCR tests before treatment, on days 1,8, and 15. The average of the tests is the baseline that post-treatment tests are compared to. After the blood draw on day 15, the 1st treatment is administered, followed by the 2nd treatment on day 17. Prior to the 3rd treatment on day 20, the first post-treatment PCR test is administered and the result is compared to the baseline. The 4th and 5th treatments are administered on days 25 and 30 respectively. On day 33 the 1st PCR test after the last treatment is administered and compared to the baseline. Additional PCR tests are administered on days 57, 64 and 71 and the average of the tests is compared to the baseline.
As an example of the effectiveness of the therapy as established in the trial, the Company reported that three subjects (3 of 10) had sustained viral load reductions of 90% or greater at 10 weeks post treatment and eight had sustained reductions of 50% or greater. Only two subjects did not respond to the therapy.
"We are encouraged by the results of this trial, particularly, the rapid and dramatic viral load reductions we saw and the fact that there were no reported adverse events related to the therapy", said Thomas J. Fagan, President of Energex Systems. Hepatitis C is just the beginning. Preliminary laboratory work we have done on SIV/HIV/AIDS suggests that this therapy will be effective in treating those viruses. It is our intention to seek approval from the Federal Food and Drug Administration (FDA) through an Investigation Device Exemption (IDE) to conduct a trial on humans inflicted with HIV/AIDS. We are excited about the potential that our technology has to manage these hard-to-treat diseases, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from them. We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for these potentially life threatening diseases," said Fagan.
Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care.
Ron
Thomas Wagner - 14 May 2005 02:27 GMT >[...] >As an example of the effectiveness of the therapy as established in the >trial, the Company reported that three subjects (3 of 10) had sustained >viral load reductions of 90% or greater at 10 weeks post treatment and >eight had sustained reductions of 50% or greater. Only two subjects did >not respond to the therapy. Sounds intriguing. However, a viral load *reduction* is relatively worthless, the virus has to be *eliminated*. It may take more than just immune system stimulation for that to be accomplished. But if you get the viral count down far enough with this, and then whack the remaining critters with a (hopefully shorter) combo-therapy, success rates might improve significantly.
I hope they get the approval to conduct more trials soon.
Thomas
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pajaritaflora - 14 May 2005 04:49 GMT > >[...] > >As an example of the effectiveness of the therapy as established in the [quoted text clipped - 15 lines] > -- > To reach me, complete my last name in the address. It sounds a bit like dialisis(sp)which has always seemed kinda freakie to me. It makes logical sense that it would work...take the blood out clean it up and put it back in........I think I'm all set with it right at take the blood out.
Maybe if it was some sexxy vampire it may be more intriguing. lol
But I do agree Thomas that it may give shorter, more succesful combo therapy results.
......Not that revving up my immune system with interferon sounds any better.
Theres a friggin war going on now. The raging ribavarin gnomes allied with evil devilish interferon, battling hard against the hepatic faction.
...and now on to less important evening news...
Whoa, Mary Ann
Jack Black - 14 May 2005 18:23 GMT Interesting post. I particularly liked the bit that says "no reported adverse events related to the therapy".
It is a bit confusing the way they use the term 'sustained' in a different way to SVR. To have 'sustained' a 90% reduction (as Thomas pointed out) is nowhere near as good as a 'sustained' viral response, meaning no virus detected six months later. Still, that the reduction was till measurable 10 weeks after treatment is a good sign. Hope we hear more on this.
Jack
> Energex System's Experimental Non-Pharmacological Treatment Shown to > Reduce Viral Load in Hepatitis C Patients [quoted text clipped - 59 lines] > > Ron Gordo Mondragon - 15 May 2005 07:06 GMT In HIV, there is a strong correlation between viral load and symptoms so maybe that's the context they're assuming for Hep C. It just might be true that have a very low, sustainable level of Hep C replication is better than a higher level.
This just strikes me as Voodoo. A small amount of blood is damaged by UV light and put back in the body, and the body responds with a strong viral immune response similar to what interferon seems to do in the Hep C combo treatment. I'd much rather know what chemicals specifically were being produced by that damage.
G
> Interesting post. I particularly liked the bit that says "no reported > adverse events related to the therapy". [quoted text clipped - 70 lines] > > > > Ron Jack Black - 15 May 2005 17:15 GMT I'd say that for any viral infection a low rate of replication would be preferable to a higher one with a rate of zero being the best of all. I'd also guess that what they'd be after eventually is a zero replication result ie. an SVR in the usual parlance.
It does sound like voodoo doesn't it but then do you really understand how interferon or rebetol work? And yes, I agree that it would be best to know exactly what was being created by that UV exposure that causes the immune response. My guess is that the UV is tearing something apart and exposing fresh peptide surfaces to the immune system. But would knowing really help that much? It's one thing to know the name of a molecule and what its normal role is, but who can predict how that molecule will react in vivo. More trials are the only way and if voodoo works, well, why not. Anybody got a chicken?
Jack
> In HIV, there is a strong correlation between viral load and symptoms so > maybe that's the context they're assuming for Hep C. It just might be [quoted text clipped - 83 lines] > > > > > > Ron Doug - 15 May 2005 17:32 GMT > I'd say that for any viral infection a low rate of replication would be > preferable to a higher one with a rate of zero being the best of all. I'd [quoted text clipped - 46 lines] >> > >> > Jack Exactly, no known drawbacks yet, can't beat that, think of how the first vaccine was introduced, the man was thought to be a quack for injecting cowpox into his own son? I don't care if you miniaturize the Russian Army and inject them into me. Let them nuke the little cretians with miniblasters and then beat the turdic dragon germs to death with clubs. I just want a cure Doug
Gordo Mondragon - 16 May 2005 03:36 GMT > I'd say that for any viral infection a low rate of replication would be > preferable to a higher one with a rate of zero being the best of all. I'd [quoted text clipped - 3 lines] > It does sound like voodoo doesn't it but then do you really understand how > interferon or rebetol work? Pretty much, although I think a lot more is known about the interferons now than was know when they were first used for treating diseases.
> And yes, I agree that it would be best to know > exactly what was being created by that UV exposure that causes the immune [quoted text clipped - 4 lines] > trials are the only way and if voodoo works, well, why not. Anybody got a > chicken? If it works, it works, and figuring out why (if it does) will no doubt lead to a lot more knowledge about how the immune system works. I guess I'm just not hopeful that the results will be replicated over time.
g
Thomas Wagner - 16 May 2005 00:41 GMT >In HIV, there is a strong correlation between viral load and symptoms so >maybe that's the context they're assuming for Hep C. It just might be >true that have a very low, sustainable level of Hep C replication is >better than a higher level. If they're really assuming that, you'd have to wonder about their competence. In all studies of liver damage progression, viral load was never found to be any influence. The main problem, I believe, (but I might be wrong there) is that you're measuring virus in the blood, but it's not doing its damage there. You could have the virus happily replicating in the liver (and damaging the cells) without showing up in significant numbers in serum. Getting the viral load down in the liver during treatment seems to help, though. If this has a similar effect and doesn't just reduce the virus in serum, it might at least help in reducing fibrosis like treatment does in relapsers.
>This just strikes me as Voodoo. A small amount of blood is damaged by >UV light and put back in the body, and the body responds with a strong >viral immune response similar to what interferon seems to do in the Hep >C combo treatment. I'd much rather know what chemicals specifically >were being produced by that damage. It does sound a bit hokey. Why would the virus numbers stay unchanged that long after treatment? That would indicate some long lasting effects that might not be entirely benign. But if it really works, and there's no long term damage, then I don't really care how it does its magic. If Voodoo really helped heal HCV, I'd be the first to advocate its widespread use. If they can produce reproducible results that go beyond viral load reduction, more power to UV magic.
Thomas
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