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motorcyclemaintainance

Starpharma Vivagel ( SPL7013 )

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motorcyclemaintainance

Vivagel is a new kind of gel that prevents the initial invasion by an infectious virus. Recent trials on animals have shown it is between 85 and 100 per cent effective at blocking HIV and Herpes (HSV).

It's been shown to be effective against HPV and other conditions. It also has contraceptive properties (reduces conception rates by 95% in preclinical studies).

VivaGel had good results in human clinical trials: it appears to be non-toxic, non-irritating, and successful at preventing these STDs. Studies also show that viruses are not evolving resistance to the microbicide.

This from the Starpharma site:

"The incidence rate of genital herpes has risen rapidly, and without intervention the prevalence in the US is expected to increase to 39% of men and 49% of women by 2025."

Wow, so in 15 years, about half of the USA will have HSV-2. If science doesn't find a treatment, then at least the stigma will have gone by the time half of the country has it.

Anyway, this Vivagel sounds great, and they're fairly close to marketing it. Durex are going to coat condoms with it. , but it can also be applied manually without a condom.

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curecomingverysoon

To my knowledge (can't find the link), Vivagel is only just started in Phase II (although Durex has purchased the option when it's approved) so we won't see it for another 3-4 years (so long, ugh). This will be good for us to have yet another way to protect uninfected partners but the blissfully oblivious will continue to transmit...

I think that it's a good thing that it's going to spread to that extent because the stigma will be gone. I have actually read that it will hit the 50% mark before 2025 but again, don't have the link at hand right now.

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notamused

ARGHHH its so frustrating - the damn thing works, so why can't we just have it?!!! I just emailed the guy from starpharma to ask when it will be available.

curecomingverysoon - I hear where you're coming from about the spread being a good thing, not that I would wish herpes on anyone but really its the stigma that I wouldn't wish upon anyone and if that goes...

I keep thinking, if only everyone had it and nobody cared..wouldn't be an issue..

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curecomingverysoon

Since they're still in Phase II now, there's no way it would've been a year from October 2007. I hate bad journalism.

I'm not sure about this stuff. Does it protect just women from getting the virus or can men use it too?

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chooseyourbattles

Do you all think this is going to work with partners?

Like, in 3-4 years (according to your estimates), I can say "Well, I have herpes, and we can use a condom, I will take Valtrex, and we will spread antimicrobial gel over the peripheral parts of our genitals, and this decreases your risk to approximately 0.0000001%."

Will that actually change someone's mind, if he was going to say no to my using simply condoms and Valtrex? As in: "Oh, those two measures are not enough, but now that we have this $8.99 miracle in a plastic tube, I am willing to have intercourse with you?"

I understand the need for the antimicrobials for health purposes. But are they really going to make that much of a difference for us?

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motorcyclemaintainance

It probably won't help with the stigma, but once the odds of transmission are that low, disclosure would be redundant. You could quite rationally be certain that you were not a risk.

Once the chance of transmission are that small, you might as well test yourself for CMV, or staph (potentially lethal, as common in the body as herpes), and "disclose" that as well.

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writeaway

heres an update from april

important bits in that article:

Starpharma Holdings Limited today announced a successful capital raising of at least A$4.3 million and up to A$4.6 million, through a private placement to existing and new institutional and sophisticated investors. This placement will boost the company’s cash reserves to over A$10 million. The additional funds raised will provide sufficient operating capital for development activities to commercialise the VivaGel® coated condom with Starpharma’s partner SSL International Plc (LSE:SSL), and to supplement

grant funding to further advance the stand-alone VivaGel® development program.

This reflects a growing confidence in the commercial prospects for the VivaGel® condom coating deal with SSL, the VivaGel® stand-alone product, and our broader product pipeline.

um yeah, im definitely going to be buying some stock in this stuff lol...

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wiltshire

This may be our first real option. Well funded and looking at going straight to phase III.

Durex are also backing the funding for research too, so there's a route to market established.

One can only hope that a phase III for an ointment/gel for external application is shorter than drugs or vaccines that are having a systemic effect rather than a topical effect. They have already shown it is not absorbed into the body (blood, fat etc).

With Durex's input it is likely to hit the high street quickly. They certainly seem to pitch this as non-prescription item. It would be extraordinary to have to go to your doctor for condom prescriptions.

I also read a while back and can't find the link again, that the rumour is it retains the antiviral effect for a lasting time, so perhaps one application every few days will be enough!

Viva la Viva

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notamused

this is really exciting.

I only with they could tell us when when when

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solvingtheproblem

straight from the horse's mouth

Here is the most recent Vivagel status report, by the CEO as part of the corporate overview. Progress is being made!

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carameldiva

Hi Motorcyclemaintenance,

I and a few others are trying to organize a walk hopefully. Have you heard any updates on who closer to the cure Dr. Bloom or Dr. Cullen. Please let me know.

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wiltshire
Here is the most recent Vivagel status report, by the CEO as part of the corporate overview. Progress is being made!

That is a very very interesting document. Have a look at the chart on page 16. Market entry with the VivaGel condom is the next step!!! At the same time they will still be studying the efficacy of just the gel alone. That is very different thing from PhaseIII Clinical which it does not seem to need. As far as I understand it, that type of study looks at how it performs in day to day use.

Think of it like this. They have established it work and is safe (well tolerated), but will people actually take to it and use it, i.e. is it commercially viable and how do people accept it. But that is the next step for the gel alone. In the meantime, there will be the condoms.

Reading it, they are fast-tracking the condom. Indeed, the vivagel condoms could be with us very soon indeed, all things going well. We must wait another 6 weeks to hear the outcome of the last trials. They are already in the Abbreviated Development Plan (abbreviated = quick?) phase, and Market is the next step.

Also, the condom factories are already in place, the technology to add lubricants all present and ready. Fill the machines up with Vivagel and press 'go'. It really could be as simple as that. The only thing that is unknown is how easy it is to make Vivagel in bulk; but I'm sure Starpharma would have looked at that early on. Would they need a special factory or machinery to make it, or do they have the existing equipment already? I have no idea.

They will of course have a few things to iron out, but at the same time, they will know the results before we ever see them. If it is a commercial go-er they will be one step ahead, as they will be eager to cash in with it after so many years of trials.

If the results of the last clinicl trials are as good, then I predict the Vivagel comdom will be with us within 18months tops. The gel itself as a standalone prophylactic will take a bit longer ...... but if by that time they are already making it in quantities for condoms, it's only going to be a case of repackaging it in a tube or applicator.

If this does not work, we will have to wait a few years for the next opportunity to break the control HSV has over our lives.

Fingers crossed

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solvingtheproblem

NIH funding

I also found it interesting that Starpharma received US$26M in NIH funding. So they *are* doing some funding of HSV2 solutions that are also HIV solutions. Lesson learned: if the UF/Duke/Harvard/Bill Halford work can be effective on HIV as well as HSV, it stands a good chance of gov'tal funding.

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cureus

It seems like starpharma is still doing well. They just released a shareholder update today.They have raised more capital which is always a good thing. They go on to speak on Vivagel... "This development represents a significant boost for Starpharma’s exposure to the market once the VivaGel® -coated condom is launched". They seem really confident that this product will in fact launch. Also, I was pleased to read this..

"In March this year the company announced the completion of patient testing in a clinical trial designed to explore the length of time the antiviral activity of VivaGel® remains after vaginal administration. This study is intended to determine how long before sex VivaGel® could be applied to prevent infection by HIV and HSV-2 (genital herpes).

Analysis of the laboratory samples and study data is progressing well with encouraging preliminary pharmacokinetic data obtained.

Data continues to support preliminary findings which indicated that the gel was safe and well tolerated by the study participants. The Company expects to be able to release the full results in the near future."

It would be nice to have another effective protective measure! Imagine if this "gel" actually curves the HIV & HSV epidemic somewhat. Staying optimistic :)

Here's the link to the information....http://www.starpharma.com/data/090602_ShareholdeUpdateJune2009.pdf

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cureus
so when will it be available to the public?

My guess is as good as yours, but I hope within next 3 years.

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unlucky30

i hope there is a cure in the next three years

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wiltshire

I agree. 3 yeas for the gel on its own, but a lot sooner for the condoms...all going well, which it seems to be.

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carameldiva

This sounds promising. Wonderful hopefully we can have either the vaccine that stops us from being contagious or a cure within five years. A few of us are organizing a Walk

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apollo99

Vivgel

I had posted this on this website back in Feb 09. I thought it would be a good idea to re-post it here.

I e-mailed Starpharma to see if I could get any info on when vivagel might hit the market and where they are in clinical testing. It took a while, but they did get back to me with some info and I thought I would post it here for all to see.

VivaGelR is undergoing clinical trials and is currently at the expanded

safety/Phase 2a stage of clinical development.

The product will not be available for sale until after the completion of all

necessary clinical trials and regulatory approval. We expect the first

regulatory approval for the VivaGelR technology to occur in 2010.

Thank you for your interest.

Yours sincerely,

Ben Rogers

Company Secretary

Starpharma Holdings Ltd

Baker Building, 75 Commercial Rd

Melbourne VIC 3004 Australia

Postal Address:

PO Box 6535

St Kilda Road Central VIC 8008 Australia

T: +61 3 8532 2702, F: +61 3 9510 5955

M: 0409 110 233 W: www.starpharma.com

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solvingtheproblem

Woohoo!!!!!!

Thank you for posting the good news!! Assuming the final trials go well, I think this will be a great thing for the HSV community. While this seems to be the next best thing to a cure for guys w/a HSV -ive partner, has anyone heard anything about how useful Vivagel will be for HSV +ive women with HSV -ive male partners?

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      Yes, just have sex wearing clothes and a condom, also don't kiss. No disclosure needed.
    • 2kroc
      Have sex  with at least one of you wearing clothes + a condom  next time, if you really want to protect him.
    • 2kroc
      All negative, Except for hepatitis B which is something you're vaccinated (They give you antibodies) against in the military. Before, I go through the trouble of re cropping another damn picture for you. I'd like to ask what your response will be if I show you the results and they're all negative?
    • 2kroc
      Universities receive most of their  funding from Pharma companies. Scientific studies aren't cheap, Pharmaceutical companies aren't going to fund research on food supplements when there's no pay off for them. It's naive to  think big businesses would fund research that'd directly decrease profit.  Then there's the possibility of the pharmaceutical companies bribing the government agencies from genuine health research, to keep themselves in business. https://thevaccinereaction.org/2018/04/big-pharma-pays-universities-for-most-medical-research-in-u-s-today/   Also, No one outside of the research community has the resources/contacts to prove they're cured. Even if they scored a negative on a western blot test/IGg, scrutinizers would just claim the virus was dormant or they never had it at all. Other than blood test, There is no easily accessible method to determine whether or not the virus is completely eradicated from your body.
    • WilsoInAus
      @2kroc where are the results of the three preceding tests?
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