Eurocine Vaccines obtains authorization to conduct the next study with Immunose™ FLU
Eurocine Vaccines today announced that the company has received authorization to conduct a phase I/II clinical study on the quadrivalent influenza vaccine candidate Immunose™ FLU, a novel nose drop formulation based on the company´s technology Endocine™ and inactivated split antigens.
Eurocine Vaccines submitted applications to the Swedish Medical Products Agency, MPA, and to the Ethics Committee in early November. The Company announced today that authorizations to conduct the study have been received from both.
- Our thoroughly prepared application and qualified dialogue with the Swedish MPA has yet again proven a success why our ambitious study has now received authorizations, says Dr. Anna-Karin Maltais, Chief Scientific Officer.
- While this study is the next step on the path to create a better, more effective influenza vaccine for children, we intend to evaluate effects in the elderly – a population with a disproportionately high number of flu-related hospitalizations and deaths. Thereby we will generate both necessary safety data to reach our mission and, in addition, open for new business opportunities along the road, says Dr. Hans Arwidsson, CEO.
The study will be conducted during the present influenza season and the results can be expected second half of 2018.
This information is information that Eurocine Vaccines AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (no. 596/2014). The information was submitted for publication, through the agency of the contact person set out above, on January 11th 2018.
Hans Arwidsson, Ph.D., MBA
CEO of Eurocine Vaccines AB
+46 70 634 0171
Eurocine Vaccines is using its clinically validated technology Endocine™ to develop patent protected nasal vaccines. Endocine™, based on endogenous components, brings advantages such as creation of both mucosal and systemic immunity, as well as needle-free and convenient nasal vaccination.
The company´s first product candidate, the nasal quadrivalent influenza vaccine Immunose™ FLU, is currently in clinical phase I/II development, targeted to become the first approved nasal influenza vaccine for children under the age of 2 years. Within the market for influenza vaccines, children is the fastest growing segment. This is due to the recommendation by the WHO to vaccinate children against influenza.
A clinical study conducted with Immunose™ FLU in young adults showed good safety and immune responses in both nasal mucosa and in serum, which constitutes a good foundation for further development. The next clinical study will take place during the present influenza season, 2017/2018, and include elderly subjects to generate necessary safety data. Concurrently, the elderly population will be evaluated as an additional business opportunity.
Eurocine Vaccines, EUCI, is traded at Aktietorget, XSAT.