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.
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.
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.
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