Admedus : HSV-2 Phase II Study Interim Update

ADMEDUS LIMITED ABN 35 088 221 078

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 Safety Review Committee unanimously agrees study should continue

 No safety issues seen in the study to date

 Admedus increases stake in Admedus Vaccines to 72%

 More than 80% of study participants have entered the study

Brisbane, Australia 27th August, 2015

Admedus Limited (ASX:AHZ) announced today that an independent Safety Review Committee
(SRC) has examined initial safety data from the first group of subjects dosed in its Herpes Simplex
2 (HSV-2) vaccine Phase II study and unanimously recommended that the trial continue without any modifications to the study.
In addition, Admedus announced it has invested further into Admedus Vaccines, the platform vaccine development company (formerly Coridon) led by Professor Ian Frazer. Admedus has increased its interest from 66.3% to 72.2%.
"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," said Admedus CEO, Mr Lee Rodne.
The SRC is comprised of an independent group of physicians who are experts in infectious diseases. The committee provides routine checks as per study protocol to ensure patient safety standards are met during each stage of the trial.
Currently over 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 and is likely to over enrol, however more volunteers are still needed to complete full enrolment.
"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," said Mr Rodne.
The trial 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.

For more information on how to participate in this trial people should go to:
www.herpestrial.com.au
The 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 primary objective of the 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.
Admedus anticipates interim data towards the end of 2015. Follow us:
Twitter: @Admedus
Facebook: www.facebook.com/pages/Admedus

Dr Julian Chick | Chief Operating Officer | Admedus Limited
Tel: +61 (0)8 9266 0100

Shevaun Cooper
+61 (0) 417 985 599 scooper@admedus.com

FTI Consulting
Simon Conway / Victoria Foster Mitchell
Tel: +44 (0) 20 3727 1000 admedus@fticonsulting.com

Admedus (ASX: AHZ) is a diversified, global 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

Admedus Vaccines 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.

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. 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.

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.

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