MOUNTAIN VIEW, Calif., Jan. 4 /PRNewswire-FirstCall/ -- BN ImmunoTherapeutics, Inc., a development-stage biotechnology company, today announced that the Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) for the company’s investigational breast cancer vaccine, MVA-BN(R)-HER2. A clinical study of MVA-BN(R)-HER2 will begin enrollment at multiple clinical sites in the U.S. in early 2007, and a parallel trial is expected to commence in Europe shortly thereafter.
MVA-BN(R)-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(R)-HER2 in combination with trastuzumab (Herceptin(R)) and chemotherapy.
The Phase I/II studies are designed to evaluate the safety and tolerability of MVA-BN(R)-HER2 and 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 patients and on tumor growth will also be explored.
Reiner Laus, MD, President & CEO of BN ImmunoTherapeutics said: “We are excited about the potential of this vaccine for treatment of women with breast cancer. We have been able to rapidly advance our program from research into the clinical development stage, due to the strong preclinical safety and efficacy profile we have seen with this vaccine candidate. It is an important achievement in this program as well as in the development of our portfolio of vaccine candidates for the treatment of major cancers.”
In preclinical studies MVA-BN(R)-HER2 demonstrated efficacy by inducing multi-pronged immunity as well as anti-tumor activity. Its in vivo anti-tumor activity was shown in multiple animal models with HER-2 expressing tumors. MVA-BN(R)-HER2 also showed activity in both preventive as well as therapeutic settings. In the most dramatic model, a 14-day experimental, highly aggressive lung metastasis model, MVA-BN(R)-HER2 virtually eradicated the tumor by the 14-day evaluation point. Near eradication of an aggressive metastasis was also seen after a single injection of MVA-BN(R)-HER2 was administered three days after the intravenous induction of the experimental lung metastasis. Moreover, MVA-BN(R)-HER2 induced an extremely rapid immune response.
BN ImmunoTherapeutics’ core technology is a proprietary recombinant viral vector platform based on Modified Vaccinia Ankara BN (MVA-BN(R)) that is being developed as an immunotherapy for breast, prostate and other cancers. Located in Mountain View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian Nordic (CSE: BAVA), headquartered in Denmark.
Bavarian Nordic is a leading international biopharmaceutical company focused on developing and producing innovative vaccines to prevent and treat infectious diseases and cancer. Bavarian Nordic’s patented technology, MVA-BN(R), has been demonstrated in clinical trials to be one of the world’s safest multivalent viral vectors for the development of vaccines. For more information, please visit: www.bavarian-nordic.com.
“Safe Harbour” Statement under the Private Securities Litigation Reform Act of 1995:
Except for the historical information contained herein, this release contains “forward-looking statements” within the meaning of the Private Securities Reform Act of 1995. No “forward-looking statement” can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any “forward- looking statement”, whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic’s periodic reports, if any, which we incorporate by reference.
Bavarian Nordic A/S
CONTACT: Elizabeth Dempsey Becker, of Bavarian Nordic, Inc.,+1-202-725-0501
Web site: http://www.bavarian-nordic.com/
