• Phase II study initial data expected in the coming weeks
• Company and investigators currently blinded to study results to protect integrity of data
Brisbane, Australia 15 February 2016
Admedus Limited (ASX: AHZ) today announced the Company continues to work closely with the contract research organizations (CROs) to get firm timelines for releasing interim data on its HSV-2 therapeutic vaccine Phase II study.
As reported in the Company’s last quarterly financial report (4C) that was lodged on the ASX on the 28th January 2016 and the Company’s End of Year Update lodged on the ASX on the 24th December 2015, the Company anticipates that initial study results will be available in the current quarter.
“We’re currently working closely with our study coordinators to get solid timelines for releasing interim data on our Phase II HSV-2 study. We will communicate updates on this timing and interim data as soon as it is made available to us, which we anticipate in the coming weeks”, said Admedus CEO Mr Lee Rodne.
To date, the Company and investigators remain blinded to study data in accordance with standard clinical study procedures to protect the integrity of the results. The first of a series of data from the study is expected to be available in the coming weeks, with further data to be released during 2016.
The HSV-2 Phase II study has enrolled over 40 study participants. Each study participant will receive either the vaccine or a placebo. The vaccine is initially given as a 3 injection vaccination program, four weeks apart, plus study participants will also receive another injection, a ‘booster’ as it were, 6 months after the last of the 3 vaccinations.
The study is designed to examine the safety of the HSV-2 vaccine in people with HSV-2 as well as look at its ability to stimulate an immune response against the virus.
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Dr Julian Chick | Chief Operating Officer | Admedus Limited
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About Admedus Limited
Admedus (ASX: AHZ) is a specialist healthcare company. Our focus is on investing in and developing next generation technologies with world class partners, acquiring strategic assets to grow product and service offerings and expanding revenues from our existing, profitable medical sales and distribution business. The company has assets from research & development through clinical development as well as sales, marketing and distribution.
Admedus has commercialised its innovative tissue engineering technology for regenerative medicine in four continents. We also have a major interest in developing the next generation of vaccines with a Brisbane-based research group led by Professor Ian Frazer. The vaccine programmes target disease with significant global potential, such as Herpes and Human Papillomavirus.
Further information on the company can be found on www.admedus.com
About Admedus Immunotherapies
Admedus Immunotherapies was founded in 2000 by the founder inventor Professor Ian 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. The company’s overall objective is to utilise its unique optimisation technology to produce prophylactic and/or therapeutic DNA vaccines for a range of infectious diseases and cancers in humans.
About Admedus Immunotherapies’ optimised technology
Admedus Immunotherapies 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. This strategy enhances the degradation of the protein and optimises T cell responses, while preserving structural epitopes necessary for B cells responses, resulting in vaccines with prophylactic and therapeutic potential.
About Genital Herpes
This disease often results in recurrent painful sores in the genital area. HSV-2 is the major causative agent of genital herpes. As well as 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 herpes treatment involves the use of antiviral drugs which can reduce, but not eliminate, outbreaks and shedding and therefore do not prevent spread of the disease. According to research reported in Biomed Central’s journal BMC Infectious Diseases, the economic burden of genital HSV infection and resulting complications has been estimated to be greater than $1 billion annually in the USA alone.
