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National Cervical Cancer Coalition


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PostPosted: Fri Nov 14, 2008 10:23 am 
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Greatful et al.,

I just received a response to my email to the folks conducing the study to see if a tweaked version of Gardasil will work in clearing genital warts. The trial manager said they expect news shortly, are still working on data entry and will analyze it when that task is finished.

I'll post news as soon as I have any.

Fredo

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PostPosted: Fri Nov 14, 2008 12:35 pm 
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Background on this topic:

Early Trials Show Therapeutic HPV Vaccine is Safe

HPV News (June 2007)

Researchers now shifting focus to how effective the vaccine is in treating genital warts

An experimental HPV vaccine designed to treat genital warts has shown to be safe midway through clinical trials in Australia, according to the trial manager.

The vaccine, currently being studied by researchers at Queensland University in Brisbane, utilizes technology similar to that found in prophylactic HPV vaccines that seek to protect against HPV infection by stimulating an immune response against to virus much higher that what occurs as the result of natural infection. The Australian vaccine is therapeutic, however, in that it’s designed to treat existing cases of external genital warts rather than protect against new HPV infections. Pilot studies done by QU’s research partner, Wenzhou Medical College in China, showed the vaccine has potential in treating genital warts in humans.

A press release on QU’s site says more than 200 subjects have participated in trials for the vaccine. Trial manager Dr. David Jardine told HPV News “The primary aim of this phase 1B trial are safety and tolerability, which has been shown to date in the trial with no serious adverse events reported in Australia or China at the halfway mark.” Dr. Jardine says the trial is slated to continue through April 2008, with investigators now focusing on the effectiveness of the vaccine.

(C) 2007-08 The American Social Health Association
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Posted November 14, 2008
by Fredo

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PostPosted: Fri Nov 14, 2008 2:48 pm 

Joined: Sun Nov 02, 2008 3:44 pm
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Hi Fredo,

Does this mean it essentially "flushes" the virus away completely in men? (In the modified Australian version)?


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PostPosted: Fri Nov 14, 2008 4:36 pm 
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It's hard to say, boonieboy. I don't know if they're looking to see if just warts are cleared, or if they will do DNA tests to see if the virus can be detected. Part of the problem is that experts think the virus can exist in very tiny quantities beneath the skin, in an undetectable state. However, virus in such a state is not likely to cause additional warts and most researchers would question how likely it is to then be transmitted.

Hopefully we'll hear something from this research soon. I thought these trials were ending back in April!

Fredo

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PostPosted: Fri Nov 14, 2008 4:45 pm 

Joined: Sun Nov 02, 2008 3:44 pm
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Very interesting times. Very exciting as well.

Fredo, I was wondering if you would be able to see my other thread located here: http://www.ashastd.org/phpbb/viewtopic.php?t=5117 and provide any insight? Thanks in advance!


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PostPosted: Fri Nov 14, 2008 4:59 pm 

Joined: Sat Jan 19, 2008 6:16 pm
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Fredo,

Thank you for the update Sir. Now could you write them back and tell them that there is roughly 80% of the country willing to help them out with their "data entry"?
:D

Seriously though I hope the results turn out to be positive...I don't want to jinx anything just yet.


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PostPosted: Fri Nov 14, 2008 8:30 pm 

Joined: Fri Aug 01, 2008 1:12 pm
Posts: 92
Quote:
Does this mean it essentially "flushes" the virus away completely in men?


I am no doctor but it would possibly do two things. One it can hunt down the virus while its hiding and destroy it thus eliminating it. The other way is that every time the virus reappears the body destroys it knowing what it is immediately but the the body would destroy it all so it couldn't go back into hiding. So every time the virus appears there's less and less of it in hiding.


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PostPosted: Fri Nov 14, 2008 8:43 pm 

Joined: Sun Nov 02, 2008 3:44 pm
Posts: 67
8) :shock:


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PostPosted: Sat Nov 15, 2008 1:50 am 

Joined: Sun Nov 02, 2008 3:44 pm
Posts: 67
Found the article. Pretty amazing stuff here. Hope all goes well:

from: http://www.biotechnews.com.au/index.php/id;89630440

Quote:
A research team at the University of Queensland, headed by Prof Ian Frazer, is said to have developed a new, therapeutic vaccine for genital warts, and is about to begin phase II trials in Australia and China.

Frazer's research group at the Centre for Immunology and Cancer Research (CICR) has 'tweaked' two antigen components of in the original vaccine to target HPV6 and HPV11, the main agents of visible genital warts.

Frazer's original prophylactic vaccine, now being developed my Merck & Co and CSL, was designed to induce strong antibody-mediated immunity against the four primary strains of HPV that cause genital warts, to protect females who are not yet sexually active against HPV infection and cervical cancer.

But like most vaccines, the new HPV prophylactic vaccine, CICRVAX6, does not elicit cytotoxic T-cell immunity, which is essential to eliminate already-infected cells, so it cannot be used to cure established cases of genital warts.

The virus is transmitted through skin contact, and the only current treatment for the warts is to burn them off with chemicals, freeze them off, or remove them surgically.

CICR business manager Anton Sanker said such procedures are costly, and invasive for females, who can develop internal genital warts on the mouth of the cervix.

Frazer's original vaccine primarily targets the two main virus strains responsible for most cervical cancer, HPV16 and HPV18. While HPV6 and HPV11 are the major cause of visible genital warts, they account for only a small percentage of cervical cancers.

"We're fairly optimistic about the chances that this new vaccine will protect against HPV6 and HPV11, and if the trials go well, we're optimistic it will work for HPV16 and HPV18 as well," Frazer said.

He said that if the trial was successful, the next step might be to combine the two vaccines into one, to prevent and eliminate genital warts, and prevent cancer.

The trials will be conducted in Brisbane at Princess Alexandra Hospital Sexual Health, and in China at Wenzhou Medical College, the CICR's research partner. The Brisbane trial aims to recruit 120 men and 120 women aged 18 to 65, with recurrent genital warts.

The 18-month trial will be launched in conjunction with Wartfest, an annual expo featuring new developments and treatments for warts, HPV and cancer.


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PostPosted: Tue Nov 18, 2008 1:35 am 

Joined: Sun Nov 02, 2008 3:44 pm
Posts: 67
Please keep us updated Fredo! :)


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PostPosted: Tue Nov 18, 2008 9:42 am 
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Will do! I'm eager to hear what their data show.

Fredo

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PostPosted: Mon Nov 24, 2008 2:16 pm 

Joined: Sun Nov 02, 2008 3:44 pm
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Hey Fredo,

Quick question: Depending on if things go well with the 2nd clinical trial currently taking place in China and Brisbane, what is the likelihood of a therapeutic vaccine being available within 5-10 years? Or would it be easier to gauge once (if and when) the phase III trials are underway?

Actually, this isn't a quick question :P

Do you know the actual science behind the vaccine? Obviously there is no cure for the common cold virus, so would it be safe to say this just is an immune booster for immunosuppressed or immunocompromised individuals? Or would it actually eradicate the virus (the wart strains) from the body completely? I'm not sure if you've been given these details yet, but I just thought I'd try to pick your brain some more. :D

Thanks for answering.


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PostPosted: Tue Nov 25, 2008 7:04 pm 

Joined: Sat Jan 19, 2008 6:16 pm
Posts: 370
That's a complicated question that nobody can answer for sure yet but from what I've read....

Cells that are infected by HPV are able to reproduce themselves by "hiding" from the immune system. Your body has what are known as T-cells that attack and kill infected cells. One of the challenges with HPV is that it can trick the immune system to not attacking it. What the therapeutic virus is attempting to do is teach the T-cells to attack the HPV cells that are emitting these proteins anyway. In effect it teaches your body to kill the virus. How effective this will be or if it will work at all is still to be seen. They've had good results in the preliminary trials, but they have to follow the testing process to have any hopes of getting a license.


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PostPosted: Wed Dec 03, 2008 10:43 am 

Joined: Wed Nov 19, 2008 4:23 pm
Posts: 21
I understand that Transgene have also been testing a therapeutic vaccine which has shown promising results against cervical lesions. They're into Phase III testing already.

I have been reading a LOT about this recently, and there do seem to be some hopeful developments on the way. So while I am still terrified about the prospect of developing an HPV-related cancer (particularly an oral one) or causing my partner an infection that leads to a cancer, research is moving forward all the time. And given that research into oral HPV has only really been gaining prominence in the last five years or so, I hope that there will be better diagnostic and therapeutic techniques available if I should ever need them. There seems to be a lot of momentum in the fight against HPV-related cancers at the moment.


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PostPosted: Sat Dec 06, 2008 10:23 am 

Joined: Mon Dec 01, 2008 6:38 pm
Posts: 16
What current testing Phase are the Australian clinical trials completing..? I or II..?


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