First Participant Dosed in Phase 1 Clinical Trial of Gamma-PN in Older Adults
The Phase 1 clinical trial will assess the safety, tolerability and immunogenicity of Gamma-PN. One hundred and five healthy volunteers aged 70 and over 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 the licensed pneumococcal vaccine Prevnar13®.
Following the completion of cohort one involving administration of 500 µg of Gamma-PN, safety data will be presented to a Safety Review Committee to permit progression to cohort two, in which 1000 µg of Gamma-PN vaccine will be administered. Subsequently, cohort 3 participants will receive 1500 µg of Gamma-PN vaccine.
GPN Vaccines’ Chief Medical Officer Professor Paul Rolan, said “This is an exciting milestone for GPN Vaccines underpinned by our first clinical study last year demonstrating Gamma-PN is safe and produces an immune response in the 50-to-69-year age group. 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 Fusion in Adelaide, one of Australia’s largest and most experienced clinical trials centres, with oversight from Datapharm.
GPN Vaccines’ Chief Executive Officer Dr Tim Hirst, said “We are incredibly grateful for the support of our many investors from Australia and around the world who have made it possible to run this study, and to continue building on our current knowledge of Gamma-PN. Our vaccine aims to solve the growing problem of the emergence of new strains of Streptococcus pneumoniae which are a major cause of morbidity and mortality in the elderly”.
For further information on the clinical trial or to register your interest, please visit: https://fusiontrials.com.au/trial/f01924-pneumococcal-vaccine-trial/
About GPN Vaccines
GPN Vaccines is a clinical stage, public (unlisted) biotechnology company focussed on creating innovative vaccines that offer robust protection against the world’s most important bacterial pathogens. Our lead product, Gamma-PN, targets Streptococcus pneumoniae which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). There are over 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. Gamma-PN is being developed to protect children and adults against all S. pneumoniae strains, regardless of strain serotype. Additional vaccines are also in development that target other bacterial respiratory infections and are designed to offer similar broader spectrum immunity.
Tim Hirst
GPN Vaccines
+61 420 942 824
tim@gpnvaccines.com
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