An independent Safety Review Committee (SRC) unanimously recommended that the trial continue without any modifications after examining initial safety data from the first group of subjects dosed.
No safety issues have been seen in the study to date.
The company has also increased its interest in Admedus Vaccines – the platform vaccine development company, formerly Coridon, led by Professor Ian Frazer – to 72.2% from 66.3%.
More than 80% of the required study participants have either begun screening or received their initial dosing regimen.
The company will continue to recruit people into the study to complete full enrolment.
Interim results are expected towards the end of 2015.
The SRC is comprised of an independent group of physicians who are experts in infectious diseases.
It provides routine checks as per study protocol to ensure patient safety standards are met during each stage of the trial.
Lee Rodne, chief executive officer, commented:
“The outcome of the SRC review is extremely positive and provides further support for the safety profile of our HSV-2 therapeutic vaccine study.
“The trial is progressing well, with some participants already receiving their first three doses, and we look forward to the anticipated interim results.
“The data and progress of the HSV-2 and HPV programs and overall development of the technology is extremely positive and we continue to support Professor Frazer and the team.”
Admedus’ HSV-2 therapeutic vaccine is based on a platform technology initially developed by Professor Frazer. The technology is designed to enable, boost and support the body to fight against diseases, such as HSV-2.
The primary objective of the Phase II study is to explore both the safety of the therapeutic vaccine in people with HSV-2 and assess efficacy through evaluating changes in T-cell counts, HSV-2 viral shedding and viral outbreaks.
It is being run in Brisbane by Q-Pharm at the QIMR Berghofer Medical Research Institute.
The study involves participants undertaking a 45 day pre-vaccination period to establish a baseline and then each participant will receive three monthly intra-dermal injections, followed by a fourth injection 6 months after the initial dose.
A total of 40 otherwise healthy HSV-2 positive volunteers are needed for the trial, although the study does allow for over enrolments.
Admedus Vaccines was founded in 2000 by the Professor Frazer as a private unlisted company, to develop and commercialise patented technology for improving immune responses to DNA vaccines licensed by UniQuest Pty Ltd and developed at the University of Queensland.
The company has laboratories within the Translational Research Institute at the Princess Alexandra Hospital in Brisbane.
It seeks to utilise its unique optimisation technology to produce prophylactic and/or therapeutic DNA vaccines for a range of infectious diseases and cancers in humans.
Admedus Vaccines has 6 granted US patents protecting its codon optimisation DNA technology, which enhances protein expression in the cell or tissue targeted and results in an improved humoral response.
The second component of the technology, also patent protected, is to use a mixture of DNAs encoding ubiquitinated and non ubiquitinated proteins.
HSV-2 is the major causative agent of genital herpes, which often results in recurrent painful sores in the genital area and for which there is no cure. Infection is also life-ling.
Besides pain and discomfort to infected individuals, the virus can have serious health implications for babies born to infected women.
Herpes is also believed to aid in the transmission of HIV.
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 U.S., the Center for Disease Control estimates that 16% of Americans between the ages of 15 and 49 are infected with the virus.
The unanimously recommendation that the Herpes Simplex 2 vaccine Phase II study continue without any changes is a safety milestone for Admedus.
Progress continues to be made with more than 80% of study participants having joined the study and some participants already receiving their first three doses.
Progression through the study continues to add value for Admedus given that 1 in 6 people aged between 14 and 49 in the U.S. are estimated to be infected with HSV, which has no present cure.
As such, a vaccine could potentially address a market worth more than US$6 billion.
Interim results of the study are expected before the end of this year while the phase II study is expected to be completed towards the end of this financial year with final results to be completed around this time next year.
Gaining an increased shareholding in Admedus Vaccines to 72.2% will increase the revenue and income potential for the company as Professor Frazer’s HPV vaccine proceeds into clinical studies in the coming year.
In addition to the HSV-2 progress, the company has additional strings to its bow.
Share Price Catalysts:
- 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);
- Expanded ADAPT pipeline in areas such as vessel repairs, cellular therapies and progressing our dura mater product towards studies for market approvals;
- Interim results from the HSV-2 Phase II study expected towards the end of 2015; and
- HPV vaccine progressing into clinical studies this year.
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