Innogenetics completes first US clinical trial on time
Safety and tolerability results of hepatitis B therapeutic vaccine phase I study
Innogenetics announced that it has successfully completed its first clinical study in the United States under Investigational New Drug status (IND).
In April 2004, Innogenetics took over sponsorship of a phase I safety and tolerability study under US IND for the hepatitis B therapeutic vaccine candidate, acquired from Genencor, based on Epimmune's polyepitope technology.
Final results of the phase I study showed that intramuscular injection with either a 0.4-mg or 4-mg dose of this DNA vaccine, administered every 4 weeks over a period of 12 weeks (a total of 4 doses), was safe and well tolerated in all healthy volunteers.
As planned, the next steps in the clinical evaluation program will be to deliver the hepatitis B polyepitope using a DNA vaccine and a viral vector in order to maximize the immune response.
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