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BN ImmunoTherapeutics Starts Trials With New Breast Cancer Vaccine
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: http://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
http://www.bavarian-nordic.com
View drug information on Herceptin.
BN ImmunoTherapeutics începe New studii clinice cu vaccin cancer de sân - BN ImmunoTherapeutics Starts Trials With New Breast Cancer Vaccine - articole medicale engleza - startsanatate