The Stratis needle-free injection system will facilitate the delivery of a vaccine against SARS-CoV-2 in the clinical study
PharmaJet’s Stratis needle-free injection system has been selected for use in the Covid-19 clinical trial in Australia.
The Stratis needle-free injection system, which is designed to avoid needle-stick injuries, needle reuse and cross-contamination, will help deliver a vaccine against SARS-CoV-2 in the clinical study.
French-Thai pharmaceutical company BioNet, along with Melbourne-based biotech firm Technovalia, has developed a DNA-based vaccine called Covigen to treat Covid-19.
The trial is being conducted at vaccine trial sites such as the University of Sydney, the Telethon Kids Institute in Perth, the University of Adelaide and the Vax4COVID alliance. The trial is also financially supported by Australia’s Medical Research Future Fund.
According to the company, the PharmaJet system has been selected due to its record of enhancing the efficiency of DNA vaccines and the speed of the delivery system compared to traditional needle and syringe.
The funding will also enable researchers to conduct a phase 1/1b clinical study to assess the safety and effectiveness of the vaccine in 150 healthy volunteers.
BioNet CEO Hong Thai Pham said: “We are glad that our collaboration with PharmaJet has led to the rapid development of a DNA vaccine which will enter soon in a human trial conducted by an alliance of clinical experts in Australia.”
“This validates our years of development on recombinant vaccines and our DNA technology platform.”
Stratis system enables the delivery of medications and vaccines either intramuscularly or subcutaneously
PharmaJet has already secured 510(k) clearance from the US Food and Drug Administration (FDA), as well as CE mark approval and WHO PQS certification for Stratis system to deliver medications and vaccines either intramuscularly or subcutaneously.
The company has also secured CE mark approval and WHO PQS certification for Tropis system for intradermal injections.
PharmaJet president and CEO Chris Cappello said: “We are pleased to be collaborating with BioNet-Asia and their partners as they move into human clinical trials.
“Our Needle-free Systems provide the platform to get vaccines directly into cells to help maximize target gene expression in the body. Our findings from multiple clinical studies with other DNA vaccines have resulted in improved efficacy using our devices.”
In January 2018, PharmaJet announced that a study had found that its needle-free injection was superior to needle and syringe for fractional dose poliovirus vaccine campaigns.