16 Jan 2023 First Participant Dosed in Phase 1 Clinical Trial of Gamma-PN Vaccine
Adelaide, Australia, 16th January 2023
GPN Vaccines Ltd is pleased to announce that the first participant has been dosed in its Phase 1 clinical trial of Gamma-PN vaccine in healthy volunteers.
The Phase 1 clinical trial will assess the safety, tolerability and immunogenicity of Gamma-PN. One hundred and seventeen healthy volunteers aged 50-69 will be recruited into the trial, of which ninety will be vaccinated with Gamma-PN at three different dose levels. The remainder of volunteers will be given either a placebo or a licensed pneumococcal vaccine currently used in Australia.
Following the completion of cohort one involving administration of 50 µg of Gamma-PN, safety data will be presented to a Safety Review Committee to permit progression to cohort two, in which 250 µg of Gamma-PN vaccine will be administered. Subsequently, cohort 3 participants will receive 1000 µg of Gamma-PN vaccine.
GPN Vaccines’ Chief Medical Officer Professor Paul Rolan, said “This is an exciting milestone for GPN Vaccines underpinned by many years of medical research on producing a better pneumococcal vaccine. We are grateful to the volunteers who are playing an important role in testing this vaccine, which has the potential to save millions of lives per year”.
The clinical trial is being conducted at CMAX in Adelaide, one of Australia’s largest and most experienced clinical trials centres, with oversight from Southern Star Research.
The Chief Executive Officer of CMAX Jane Kelly, said “As a South Australian business, we are proud to be partnering with local biotech company GPN Vaccines on this exciting vaccine program. There are many advantages to running this type of study in Adelaide including the demographic and relatively low transmission of COVID-19 ”.
The clinical trial was generously supported by a $1 million grant from the South Australian Government’s Research and Innovation Fund.
GPN Vaccines’ Chief Executive Officer Dr Tim Hirst, said “We are incredibly grateful for the tremendous support of the South Australian Government and the many investors from Australia and around the world who have made it possible to run a first-class trial in Adelaide. The trial aims to solve the growing problem of new strains of Streptococcus pneumoniae emerging for which current licensed pneumococcal vaccines are no longer effective”.
For further information on the clinical trial or to register your interest, please visit https://www.cmax.com.au/upcoming-trial-cm0222/
About GPN Vaccines
GPN Vaccines is a public (unlisted) biotechnology company developing a vaccine against Streptococcus pneumoniae, which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). Each year it causes 1-2 million deaths worldwide, killing more children than AIDS, malaria and tuberculosis combined. There are now 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. GPN Vaccines’ product, called Gamma-PN, is being developed to protect children and adults against all S. pneumoniae strains, regardless of serotype.
Professor Tim Hirst Prof Paul Rolan
Chief Executive Officer Chief Medical Officer
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