COPENHAGEN, Jan 3 (Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.
Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.
BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.
The two studies are expected to enroll up to 60 patients and are designed to evaluate the safety and tolerability of the vaccine. Its effect on the clinical progress of the patients and on tumor growth will also be explored.
o determine how best to incorporate the vaccine into standard therapy, it will also be tested in combination with traztuzumab (Herceptin) and chemotherapy.
In Europe, the vaccine will also be tested in first-line therapy of metastatic breast cancer, Bavarian said.© Reuters 2007