Viva-Gel Phase 3 Trial Gets Go-Ahead from FDA | Innovations

Viva-Gel Phase 3 Trial Gets Go-Ahead from FDA

Viva-Gel Phase 3 Trial Gets Go-Ahead from FDA

Posted 23 October 2011, 12:00 AEST

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DESLEY BLANCH : Bacterial Vaginosis is a disease of the vagina caused by an imbalance of naturally occurring bacterial flora that can have a severe impact on a woman's health, self-esteem and ability to give birth to healthy babies.

JACKIE FAIRLEY, CEO, Starpharma : The bacterial vaginosis activity of Viva-Gel was a sort of fortuitous observation that we made in one of the human studies that we were running. We went back and looked at the effect more closely and have found that not only is it highly active but this is a disease area which is very poorly served by existing products. So we've got affected women and clinicians very excited about the prospect of having a product which is not a conventional antibiotic and which is efficacious and doesn't have a lot of toxicities.

DESLEY BLANCH : That's Jackie Fairley, CEO of Starpharma, an Australian biotechnology company that's leading the field in developing new technologies and accumulating wins across a broad range of markets.

Their lead product is Viva-Gel, a vaginal gel that women can apply to protect themselves against HIV and genital herpes.

A little over a year ago Starpharma kicked off a different application for the product -- for the world's most common vaginal infection, Bacterial Vaginosis which is an imbalance between the normal flora bacteria and pathogenic or bad bacteria, and causes fertility issues, increased risk of premature births and can increase a woman's chance of acquiring HIV or other STIs.

It's just been announced by the company after the very positive Phase 2 results that the United States Food and Drug Administration has approved Phase 3 clinical trial to use Viva-Gel as a treatment for bacterial vaginosis.

Jackie Fairley says BV is the most common vaginal infection in the world.

JACKIE FAIRLEY : Look, it is a very common infection particularly in the U.S. where it affects a significant proportion, around 29 per cent of women in the U.S. and in fact, in certain populations in the US it's as much as 50 per cent in the Hispanic and African-American populations it appears to be over represented, so it is a very common infection indeed.

DESLEY BLANCH : Well, you must be delighted with this announcement of the design of the Phase 3 trials and the go-ahead for them. So how will the trial be shaped and what countries are you recruiting in?

JACKIE FAIRLEY : We will be conducting these two Phase 3 studies in parallel. It's a requirement to do two studies in this final phase of development for a pharmaceutical and because it is such a prevalent condition in the U.S., we will be conducting both of those studies in the U.S. in a number of centres really sort of spanning the country in fact.

DESLEY BLANCH : And is it only confined to America or is it really widespread?

JACKIE FAIRLEY : Oh, look it's actually a condition which occurs throughout the world and probably is perhaps better documented in the U.S. than some other markets, but there's no question that it's a common condition throughout the world.

DESLEY BLANCH : So what are some of the problems that face those infected by bacterial vaginosis?

JACKIE FAIRLEY : Well, it has a combination of some unpleasant and disruptive symptoms -- discharge and odour which the affected women find very difficult to deal with. It is a disease where you have a number of bacteria which are pathogenic or bad bacteria growing and they do have some long term deleterious effects and so this condition is associated with pelvic inflammatory disease that people will be aware of and then the subsequent infertility that follows from that.

There's also an increased risk of pre-term birth or still births associated with women affected with this condition during pregnancy and it also can increase the risk of other sexually-transmitted diseases such as HIV, so it really has some very serious effects.

DESLEY BLANCH : Your company has developed dendrimer technology and it's the basis for what makes the technology so versatile. So tell us first what are dendrimers?

JACKIE FAIRLEY : Dendrimers are really a kind of polymer. If you think of a polymer being something which is many sub-units in a molecule, the dendrimer version is simply a spherical polymer made up in a very precise and reproducible manner and so we're able to control the way we build those polymers in a very precise manner and therefore we can build them so they're applicable to either pharmaceuticals as in the case of the Viva-Gel product where it's an anti-viral and anti-bacterial product or in fact in agri-chemicals or drug delivery or invitro-diagnostics, we build a different kind of dendrimer.

DESLEY BLANCH : Last week, when the Nobel Prize for Chemistry was announced, your technology made it onto a list as a possible winner. How exciting was that! So whose list was that?

JACKIE FAIRLEY : It was a very exciting position for us to be in. It was actually the Thomson Reuters analyst David Pendlebury each year publishes a list of Nobel Prize predictions and that's based on the number of citations in the literature over the previous year and dendrimers are extraordinarily versatile in their application and have been credited with a great deal of applications in a wide variety of product categories, so it was very exciting.

We were disappointed that Professor Tamalia who was one of our company's founders and was an important member of our staff for many years, now retired, but we were excited that he was on the prediction list and we look forward to future lists and future prizes.

DESLEY BLANCH : You might get up next year, who knows!

JACKIE FAIRLEY : Yeah, well, let's hope so.

DESLEY BLANCH : So what is the significance of these Phase 3 trials for Viva-Gel in terms of the product's timeline to market?

JACKIE FAIRLEY : Look, this is the final stage of development before one submits to the FDA or for that matter another regulatory authority for approval to be sold as a pharmaceutical agent and we'll be commencing those trials kicking off at the very beginning of next year if not late this year. They'll run through the bulk of 2012 and we'll have a result towards the end of 2012.

We'll then be partnering the drug with a pharmaceutical company for marketing and it will be at that stage that it will be submitted with a new drug application.

DESLEY BLANCH : Jackie Fairley is CEO of Australian biotechnology company Starpharma.

More information:

Dr Jackie Fairley, CEO,
Starpharma, Pty Ltd Melbourne VIC

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