GOLDEN, Colo. — Feb. 6, 2018 — PharmaJet, the maker of innovative, needle-free injection technology, today announced that Vaccibody AS is expanding their human clinical trial (phase IIa) for the study of a vaccine to treat HPV disease using the PharmaJet Stratis® needle-free injection system.
Nearly all cervical cancer is caused by high risk Human papillomavirus (HPV), with an estimated 530,000 new cases and 275,000 deaths annually, making it the leading cause of cancer deaths in women.1,2 An additional 10 million women are impacted by a long pre-invasive disease called Cervical Intraepithelial Neoplasia (CIN).2 Vaccibody, a biopharmaceutical company focused on the development of novel immunotherapies, reported successful clinical trial results last year of their therapeutic DNA vaccine (VB10.16) delivered with PharmaJet’s needle-free injection technology. The trial showed that the vaccine had an excellent safety profile, and induced the strongest HPV16-specific immune response that has been reported in literature.2 Recruitment has now been finalized for the phase IIa human clinical trial.3
“We are encouraged by the interim results and expansion of the Vaccibody clinical trial, using needle-free delivery to treat HPV disease,” said Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc. “Our needle-free devices continue to help novel DNA technologies move successfully from pre-clinical studies forward into early and late stage clinical trials.”
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1 World Health Organization, June 2016, Media Fact Sheet, http://www.who.int/mediacentre/factsheets/fs380/en/
2 Vaccibody announces positive results from the 12-month analysis of the Phase 1 part of the clinical trial VB C-01 in patients with high-grade cervical dysplasia, June 21, 2017
3 Vaccibody AS announces finalization of the recruitment in the phase IIa part of its study with VB10.16, December 12, 2017