Interim analysis data from the investigation into the vaccine's safety and efficacy in 40 subjects who carry the HSV-2 virus but are otherwise healthy is anticipated in the fourth quarter this year.
"The study is the next step in realising the potential of the HSV-2 therapeutic vaccine, building on the positive data shown in the Phase I study where this vaccine was able to stimulate a T-cell response against the virus," chief executive officer Lee Rodne said.
"The study enrolment is progressing well, consistent with the desire for new therapeutic treatments, and we are looking forward to the interim results later this year."
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.
Over 50% of the required 40 participants have passed the initial screening process and the first doses of the therapeutic vaccine are scheduled to be given this month.
Admedus expects that recruitment will be completed this quarter, with interim results scheduled to be released later this year.
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.
Admedus continues to advances the keenly awaited key Phase II HSV-2 study with the company anticipating interim results in the fourth quarter of 2015.
Given that there is no cure available for HSV-2, which is a life-long infection, success will allow the company to tackle an unmet medical need with an addressable market estimated at $6 billion.
Professor Ian Frazer and his team will now build on Phase 1 Study results, which found no safety issues with 19 of 20 patients showing a T-cell response - an early indicator of an effective immune response.
Frazer has an extraordinary track record with his work linking the human papilloma virus (HPV) and cervical cancer leading to the creation of a world-first vaccine.
The vaccine is an opportunity for sufferers and for Admedus to thread the needle and commercialise the work to date with big revenue potential potentially not far away.
Share Price Catalysts
- Completion of HSV-2 Phase II enrolment (end 2Q2015);
- Interim Analysis from study (4Q2015); and
- Starting Phase I study for Human Papilloma Virus vaccine.
Regenerative tissue portfolio and CardioCel®
- Increase number of centres using CardioCel® globally;
- Growing sales in the US, Asia & Europe;
- Additional market approvals for CardioCel® in Asian markets;
- Initiation of CardioCel® market expansion studies such as a Tri-leaflet Aortic Heart Valve Repair Study;
- Progress on use of ADAPT® treated tissue in the repair of dura mater, the outer membrane enveloping the brain and spinal cord; and
- Expanded regenerative tissue portfolio.
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