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Admedus Ltd receives some more positive results from HSV-2 study

Admedus Ltd has produced positive headline results.

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Admedus Ltd has produced positive headline results.

Admedus Ltd (ASX:AHZ) has produced positive headline results from an interim analysis of unblinded data from the first 20 patients, enrolled in the Herpes Simplex (HSV-2) Phase IIa study.

Of the 20 patients analysed, 15 received a vaccine while 5 received a placebo.

In the vaccine group, there was a 58% reduction in viral shedding rate compared with base line.

Given the results, an independent expert has recommended to continue to progress the development of the vaccine.

Full results from the completed study are expected in 1H 2017.

Wayne Paterson, interim CEO, commented: “The data seen from the first 20 patients, which has been independently reviewed, is very encouraging when compared to results seen from other similar vaccines in the clinic and continues to support further development of the product.”


US$1 billion market

According to research reported in Biomed Central’s journal BMC Infectious Diseases, the economic burden of genital HSV infection and resulting complications has been estimated to be greater than $1 billion annually in the U.S. alone.

Genital herpes often results in recurrent painful sores in the genital area and HSV-2 is the major causative agent.

As well as pain and discomfort to infected individuals, the virus can have serious health implications for babies born to infected women.

Current herpes treatment involves the use of antiviral drugs which can reduce, but not eliminate, outbreaks and shedding and therefore do not prevent spread of the disease.


Additional study details

All patients in the study have now completed vaccinations with no safety issues.

It is expected that full results from the completed trial will be available in 1H 2017.

The number of lesion outbreaks per year was compared between baseline screening, post vaccination and post booster.

For the vaccine group, the overall outbreak frequency was reduced by 52% post vaccination compared with baseline.

Further, an 81% reduction in overall outbreak frequency was observed post booster compared to baseline. However, a similar trend was also observed in the placebo group.

The recommendation following an independent expert review of this data, relative to results seen in other HSV-2 vaccine studies currently in the clinic, is to continue to progress the development of the vaccine.


Background

Admedus' flagship product is CardioCel®, a bio-engineered tissue scaffold to repair congenital heart defects, and expanding into the heart valve market.

CardioCel is becoming a surgeon-preferred biomaterial for heart valve repair surgeries.

It represents a disruptive technology in the $2.5 billion heart valve repair and replacement market, which is dominated by products commercialized by large medical device companies.

It is now being sold in Canada, Australia, Asia, the Middle East, and North Africa, covering 135 medical centres.

Admedus also recently received FDA 510(k) clearance to market its vascular product, VascuCel in the U.S.

The Admedus infusion portfolio has over 800 customers providing hospital-wide infusion solutions across the Australian and New Zealand healthcare systems.

Beyond CardioCel and infusion sales, Admedus is developing a DNA-based therapeutic vaccine for HSV-2 and HPV.


Recent VascuCel FDA clearance

VascuCel will be targeting the $500 million global vascular repair market.

The product launch is scheduled for November, 2016.

Admedus will launch VascuCel through the existing U.S. sales team into the peripheral vascular market where there are an estimated 250,000 vascular repair procedures performed each year.

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