Admedus Herpes Phase II – First Dosing To Commence
• Vaccine dosing to commence this month
• Enrollment on track to be completed this quarter
• On track for interim results 4th quarter, 2015
Brisbane, Australia, April 10th, 2015
Admedus Limited (ASX: AHZ) today announced an update on the Herpes Simplex 2 (HSV-2) Phase II study, which is on track to complete patient enrollment this quarter.
The Company anticipates interim analysis data in the 4th quarter this calendar year. This study will investigate the safety and efficacy of the HSV-2 vaccine in 40 subjects (18-50 years old) who carry the HSV-2 virus but are otherwise healthy.
“The study is the next step in realising the potential of the HSV-2 therapeutic vaccine, building on the positive data shown in the Phase I study where this vaccine was able to stimulate a T-cell response against the virus,” said Admedus CEO Lee Rodne.
After the initital screening, study participants have a 45 day baseline observation period on trial entry before receiving the first of their three therapeutic vaccine injections. The trial is exploring two injection regimens, which will be administered by intradermal injection three times, with a four week break between each injection regime. Admedus’ trial will also include a six month booster.
Over 50% of the required 40 participants have passed the initial screening process and the first doses of the therapeutic vaccine are scheduled to be given this month. Admedus expects that recruitment will be completed this quarter, with interim results scheduled to be released later this year.
“The study enrollment is progressing well, consistent with the desire for new therapeutic treatments, and we are looking forward to the interim results later this year,” added Mr Rodne.
The primary objective of the Phase II trial is to demonstrate the vaccine’s safety and how well tolerated it is in people with HSV-2. Secondary and exploratory objectives are to confirm the immunogenicity seen in the first study.
At present, there is no cure for herpes and the infection is life-long. 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 USA, the Center for Disease Control estimates that 16% of Americans between the ages of 15 and 49 are infected with the virus.
This technology for a therapeutic vaccine was developed by Professor Ian Frazer and his scientific team to target HSV-2, the strain of the virus most commonly associated with genital herpes.
If you would like to find out more about this study please go to:
www.herpestrial.com.au
Follow us: Twitter: @Admedus Facebook: www.facebook.com/pages/Admedus
For more information, please contact: Dr Julian Chick | Chief Operating Officer | Admedus Limited Tel: +61 3 9620 5454
Media: Haley Price +61 (0) 423 139 163 hprice@admedus.com
Media Europe & Asia Consilium Strategic Communications Jessica Hodgson / Ivar Milligan +44 (0)20 3709 5700 admedus@consilium-comms.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 is in the process of commercialising its innovative tissue engineering technology for regenerative medicine. 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 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.
About Admedus Vaccines’ optimised technology
Admedus Vaccines has six 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-cell 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.
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• Enrollment on track to be completed this quarter
• On track for interim results 4th quarter, 2015
Brisbane, Australia, April 10th, 2015
Admedus Limited (ASX: AHZ) today announced an update on the Herpes Simplex 2 (HSV-2) Phase II study, which is on track to complete patient enrollment this quarter.
The Company anticipates interim analysis data in the 4th quarter this calendar year. This study will investigate the safety and efficacy of the HSV-2 vaccine in 40 subjects (18-50 years old) who carry the HSV-2 virus but are otherwise healthy.
“The study is the next step in realising the potential of the HSV-2 therapeutic vaccine, building on the positive data shown in the Phase I study where this vaccine was able to stimulate a T-cell response against the virus,” said Admedus CEO Lee Rodne.
After the initital screening, study participants have a 45 day baseline observation period on trial entry before receiving the first of their three therapeutic vaccine injections. The trial is exploring two injection regimens, which will be administered by intradermal injection three times, with a four week break between each injection regime. Admedus’ trial will also include a six month booster.
Over 50% of the required 40 participants have passed the initial screening process and the first doses of the therapeutic vaccine are scheduled to be given this month. Admedus expects that recruitment will be completed this quarter, with interim results scheduled to be released later this year.
“The study enrollment is progressing well, consistent with the desire for new therapeutic treatments, and we are looking forward to the interim results later this year,” added Mr Rodne.
The primary objective of the Phase II trial is to demonstrate the vaccine’s safety and how well tolerated it is in people with HSV-2. Secondary and exploratory objectives are to confirm the immunogenicity seen in the first study.
At present, there is no cure for herpes and the infection is life-long. 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 USA, the Center for Disease Control estimates that 16% of Americans between the ages of 15 and 49 are infected with the virus.
This technology for a therapeutic vaccine was developed by Professor Ian Frazer and his scientific team to target HSV-2, the strain of the virus most commonly associated with genital herpes.
If you would like to find out more about this study please go to:
www.herpestrial.com.au
Follow us: Twitter: @Admedus Facebook: www.facebook.com/pages/Admedus
For more information, please contact: Dr Julian Chick | Chief Operating Officer | Admedus Limited Tel: +61 3 9620 5454
Media: Haley Price +61 (0) 423 139 163 hprice@admedus.com
Media Europe & Asia Consilium Strategic Communications Jessica Hodgson / Ivar Milligan +44 (0)20 3709 5700 admedus@consilium-comms.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 is in the process of commercialising its innovative tissue engineering technology for regenerative medicine. 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 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.
About Admedus Vaccines’ optimised technology
Admedus Vaccines has six 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-cell 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.
Help employers find you! Check out all the jobs and post your resume.