Sign up Australia
Proactive Investors - Run By Investors For Investors

Admedus moves to second dose of Herpes vaccine

About 25% of the target study numbers have successfully received their initial dose of the therapeutic vaccine with no safety issues reported. Patient recruitment is on track for completion by the middle of the year.
Admedus moves to second dose of Herpes vaccine

Admedus Limited (ASX:AHZ) continues to progress its Herpes Simplex 2 (HSV-2) Phase II study with initially enrolled participants now starting to receive their second dose of the therapeutic vaccine.

Interim data from the study into the vaccine’s safety and efficacy is expected in the fourth quarter of 2015 with final data expected in 2016.

About 25% of the target study numbers have successfully received their initial dose, which is well-tolerated with no safety issues reported.

The study is on track to recruit the required number of participants by the middle of the year, with hundreds already registered to participate.

Admedus’ HSV-2 therapeutic vaccine is based on a platform technology initially developed by Professor Ian Frazer. The technology is designed to enable, boost and support the body to fight against diseases, such as HSV-2.

“The study is progressing extremely well and we anticipate it will be fully enrolled in the coming weeks, with interim results scheduled for later this year. To date, the safety profile of the study has been very positive,” chief executive officer Lee Rodne said.

“The first study participants have now received their second dose of the vaccine. Currently 70% of the required study participants have either begun screening or received their initial dosing regimen so we’re on track.”


Phase II Trial


The primary objective of the Phase II trial is to demonstrate the vaccine’s safety and how well tolerated it is in people with HSV-2.

Secondary and exploratory objectives are to confirm the immunogenicity seen in the first study.

After the initial screening, study participants have a 45 day baseline observation period on trial entry before receiving the first of their three therapeutic vaccine injections.

The trial is exploring two injection regimens, which will be administered by intradermal injection three times, with a four week break between each injection regime.

Admedus’ trial will also include a six month booster.


HSV-2

At present, there is no cure for herpes and the infection is life-long.

Current therapy for HSV-2 involves daily doses of antiviral drugs which can reduce, but not eliminate, outbreaks and viral shedding, so they can only reduce symptoms but are unable to prevent the spread of the virus.

One in eight Australians are infected with HSV-2 and in the USA, the Center for Disease Control estimates that 16% of Americans between the ages of 15 and 49 are infected with the virus.

This technology for a therapeutic vaccine was developed by Professor Ian Frazer and his scientific team to target HSV-2, the strain of the virus most commonly associated with genital herpes.


Analysis

With initial participants already receiving their second dose and no safety issues reported to date, Admedus’ HSV-2 Phase II study is progressing well.

HSV-2 is a life-long infection with no cure with an addressable market estimated at $6 billion.

Should the company thread the needle and commercialise the work to date, it will be well on its way towards big revenue potential.

Separately, Admedus is also progressing its HPV therapeutic vaccine, which is progressing into a clinical study in the first half of 2016.

Further news on this front is expected with the company formalising the analysis of its pre-clinical HPV data and the natural progression of the HPV clinical study in HPV infected patients.

Other share price catalysts ahead are:

- The growing number of global heart centres using CardioCel to repair heart defects including repairing heart valves;
- Additional regulatory approvals in Asia for CardioCel;
- Initiation of an aortic valve repair study to show CardioCel’s utility and advantages in aortic repair vs aortic valve replacement (aortic valve market today is large and mostly using replacement procedures as they haven’t had suitable tissue to repair); and
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing the dura mater product towards studies for market approvals.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

View full AHZ profile View Profile

Admedus Ltd Timeline

Related Articles

Paradigm Biopharmaceuticals: Access latest PPT from Proactive's CEO Sessions
May 19 2017
Paul Rennie talked timeline to clinical trial results with investors.
hepatitisC.jpg
Fri
Regulatory sign-off fires starting pistol on the commercial launch in Europe, Africa, EU Medical Devices Directive awarded CE IVD certification, molecular diagnostics, Europe, Africa, Sysmex
test tubes
Tue
Under former chief executive Peter George and his successor Shaun Chilton, it has been transformed via a series of well-judged, quickly integrated and, crucially, cash generative acquisitions

No investment advice

The information on this Site is of a general nature only. It does not take your specific needs or circumstances into consideration, so you should look at your own financial position, objectives and requirements and seek financial advice before making any financial decisions. You acknowledge and understand that neither the Company, its related bodies corporate, the information providers or their affiliates will advise you personally about the nature, potential value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter. You should read our FSG and any other relevant disclosure documents and if necessary seek persona advice prior to making any investment decision.

You understand and agree that no Content (as defined below) published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person.

You understand that in certain circumstances the Company, its related bodies corporate, the information providers or their affiliates may have received, or be entitled to receive, financial or other consideration in connection with promoting, and providing information about, certain entities on the Site and in communications otherwise provided to you.

You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate. From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

Before you act on any general advice we provide, please consider whether it is appropriate for your personal circumstances.

© Proactive Investors 2018

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use