• Study enrollment on track to complete mid-year
• No safety issues reported to date
• Interim data expected Q4 2015, final data expected in 2016
Brisbane, Australia, June 5th, 2015
Admedus Limited (ASX:AHZ) today provided a progress update for its Herpes Simplex 2 (HSV-2) Phase II study for its therapeutic vaccine programme.
Participants initially enrolled in the study have now started receiving their 2nd dose (vaccination) of the therapeutic vaccine, with the study progressing well.
Patients are still being recruited to the study and Admedus anticipates this will be complete by mid-year. The study is on track to recruit the required number of participants, with hundreds already registered to participate.
“The study is progressing extremely well and we anticipate it will be fully enrolled in the coming weeks, with interim results scheduled for later this year. To date, the safety profile of the study has been very positive,” said Admedus CEO, Mr Lee Rodne.
Approximately 25% of the target study numbers have successfully received their initial dose of the HSV-2 therapeutic vaccine. The vaccine is well-tolerated with no safety issues reported.
“The first study participants have now received their second dose of the vaccine. Currently 70% of the required study participants have either begun screening or received their initial dosing regimen, so we’re on track,” said Mr Rodne.
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 study will include administering each study participant with three monthly intra-dermal injections, followed by a fourth injection 6 months after the initial dose.
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 load.
Admedus anticipates releasing interim data towards the end of 2015.
Currently the Centers for Disease Control and Prevention (CDC) estimates 1 in 6 people in the USA between the ages of 14 and 49 are infected with HSV-2 with around 776,000 new infections annually (http://www.cdc.gov/std/herpes/stdfact-herpes-detailed.htm).
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For more information, please contact:
Dr Julian Chick | Chief Operating Officer | Admedus Limited
Tel: 1300 550 310
Media:
Haley Price
+61 (0) 423 139 163
hprice@admedus.com
Media Europe & Asia
FTI Consulting
Simon Conway / Victoria Foster Mitchell
Tel: +44 (0) 20 3727 1000
admedus@fticonsulting.com
About Admedus Limited
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 commecialised 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 Vaccines
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.
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