Admedus’ (ASX: AHZ) Phase 1 trial has achieved its primary endpoint of proving that its therapeutic vaccine for Herpes Simplex Virus (HSV-2) is safe in study subjects.
In addition, the study has also shown that the vaccine was able to generate a T-cell response, an early indicator of an effective immune response.
This is an encouraging early result and while further results are pending, highlights the vaccines' potential. Shares in Admedus are likely to trade higher today.
The dosing of study subjects was completed in December 2013 and further analysis of the data in still ongoing. Admedus anticipates providing further study data later in the year.
“This is an encouraging result for the core vaccine technology and provides us with the basis for not only progressing the Herpes therapeutic vaccine program, but also preparing the Human Papillomavirus vaccine for initial clinical studies as a therapeutic against HPV and Cervical Cancer,” chief executive officer Lee Rodne said.
The therapeutic vaccine was developed by Professor Ian Frazer and his science team at Coridon is designed to prevent transmission of as well as treat herpes simplex virus 2 (HSV-2) by stimulating the immune response to enable a patient to fight against diseases.
Admedus has a 50.1% share in Coridon.
“The results are very encouraging and we believe we should progress these programs forward,” Professor Frazer added.
“Once we complete our analysis the team will be looking to take this program into a second clinical study in patients infected with the Herpes virus”.
Herpes therapeutic vaccine trial
Coridon’s Herpes therapeutic vaccine seeks to stimulate the body’s immune system to produce T-cells – a type of antibody - targeting the virus.
The trial was undertaken by Professor Frazer and his team in Brisbane on five cohorts with four participants in each cohort.
Each participant received three doses via intradermal injection during the study, which is focused primarily on safety.
All participants were screened to exclude previous exposure to Herpes simplex virus 1 (cold sores) or HSV-2 (genital herpes on the rationale that they would have no antibodies or T cells targeting the virus.
The results will also provide an early indicator of the vaccine’s ability to generate an effective immune response.
If the vaccine is able to stimulate the person's immune system such that it is being able to generate antibodies and T-cells against the herpes virus, without actually ever being infected, it would mean that it is safe and able to activate the immune system against the virus.
This would likely prevent future herpes infections and could also clear up the virus.
HSV-2 genital herpes
Genital herpes affects more than 1 in 6 Americans between ages 14 and 49 according to the Centers for Disease Control in the U.S.
WHO estimates the number of people aged 15–49 years who are living with HSV-2 worldwide exceeds half a billion.
Most individuals infected with HSV-2 experience either no symptoms or have very mild symptoms that go unnoticed or are mistaken for another skin condition and as a result are often unaware of their infection until an outbreak occurs.
Notably, there is currently no cure for HSV-2.
The high infection rates make for a large market, which is estimated to be worth up to $6 billion.
The confirmation that the HSV-2 vaccine is safe in study subjects is a key milestone for Admedus and sets the stage for a second trial targeting patients infected with the Herpes virus. This is a very promising start for Professor Frazer and his team.
That the vaccine has also generated a T-cell response in subjects just adds to this promise.
With a high infection rate and no current cure for HSV-2, proving the vaccines ability to both protect and treat the virus opens up a massive market that has not being previously tapped.
Shares in the company are likely to open higher on the confirmation about the vaccine’s safety.
Prof Ian Frazer, is in our view one of Australia's greatest scientists. His work linking the human papilloma virus (HPV) and cervical cancer to create a world-first vaccine was outstanding - success with HSV-2 could very well lead to vaccinations for HIV or Hepatitis C.
Proactive Investors continues to believe there is ample scope for Admedus to return further progress on the trial and grow its revenue. We maintain our share price target of $0.24 to $0.28 over the next six months.
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