Bavarian Nordic A/S receives approval to start Phase I/II trials with breast cancer vaccine

KVISTGARD, Norway | Jan 03, 2007 |
Bavarian Nordic A/S announced today that its US-based subsidiary BN ImmunoTherapeutics Inc. has received approval from the US Food and Drug Association (FDA) to start clinical trials with their breast cancer vaccine, MVA-BN®-HER-2*. Patient enrolment in a Phase I/II study in the US is expected to start as soon as possible.

In addition to the US study, BN ImmunoTherapeutics is also planning to start a Phase I/II study with MVA-BN®-HER2 in Europe. The two studies are expected to enrol up to 60 patients.

The studies are designed to evaluate the safety and tolerability of MVA-BN®-HER2. The studies will also evaluate the biological activity of the vaccine by measuring HER-2 specific immune responses in treated patients. In addition, the effect of the vaccine on the clinical progress of the patients and on tumor growth will also be explored. MVA-BN®-HER2 will be tested in numerous clinical settings to determine how to best incorporate it into standard therapy for the treatment of metastatic breast cancer. This will include treatment with MVA-BN®-HER2 in combination with traztuzumab (Herceptin®) and chemotherapy. In Europe, the vaccine will furthermore be tested in first line therapy of metastatic breast cancer.

Peter Wulff, President & CEO, Bavarian Nordic said: “Entering clinical trials with our breast cancer vaccine marks yet another important milestone for Bavarian Nordic. In short time, BN ImmunoTherapeutics has succeeded in making the necessary progress for the company’s first cancer vaccine to enter clinical trials. This strengthens not only our pipeline, but also our strategy to make vaccines against cancer an important value driver in Bavarian Nordic.”

SOURCE: Bavarian

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