Bavarian Nordic Enters Clinical Trials With HIV Multiantigen Vaccine

Bavarian Nordic Enters Clinical Trials With HIV Multiantigen Vaccine

Bavarian Nordic has initiated Phase I/II clinical study with its HIV vaccine candidate: MVA-BN(R: 72.76, -0.50, -0.68%) HIV multiantigen.

A Phase I/II safety and immunogenicity study in 15 HIV-infected patients (CD4 counts > 350 ul/ml) has begun enrolment in the United States. The first safety data are expected by the end of 2008, while the immunogenicity data will be available during first half of 2009.

The MVA-BN(R: 72.76, -0.50, -0.68%) HIV multiantigen vaccine encodes eight genes from HIV, including Nef and thus represents a more advanced vaccine candidate compared to Bavarian Nordic's previous MVA-based HIV vaccine candidates, MVA HIV nef and MVA-BN(R: 72.76, -0.50, -0.68%) HIV polytope. In previous clinical studies with MVA HIV nef, Bavarian Nordic has demonstrated proof of concept for the MVA technology's ability to control HIV replication. Furthermore the vaccine was shown to be immunogenic and to induce a broad T-cell response to Nef. The MVA-BN(R: 72.76, -0.50, -0.68%) HIV multiantigen builds on these positive results and thus represents an excellent opportunity to stimulate a broad immune response to the majority of the HIV proteins that will likely have important implications in a prophylactic and therapeutic setting for HIV.

Anders Hedegaard, President & CEO of Bavarian Nordic, commented: "Our strong expertise in HIV vaccine development has expedited the development of the multiantigen vaccine and it is exciting that we now again are in clinical development with an HIV vaccine candidate. The HIV multiantigen programme indeed benefits from the data generated in our previous HIV studies, demonstrating a unique safety profile of MVA in this high-risk population, as well as the potential to control HIV replication."

KvistgArd, 27 May 2008 Asger Aamund Chairman
   About Bavarian Nordic

Bavarian Nordic (CSE: BAVA) is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer. With operations in Denmark, Germany, the USA, and Singapore, Bavarian Nordic employs over 260 people. Bavarian Nordic's patented technology, MVA-BN(R: 72.76, -0.50, -0.68%), is as been demonstrated in clinical studies, one of the world's safest, multivalent vaccine vectors for the development of vaccines against various infectious diseases such as smallpox, HIV/AIDS, as well as against breast and prostate cancer. Several MVA-BN(R: 72.76, -0.50, -0.68%)-based vaccines are in clinical Phase I and Phase II trials. Bavarian Nordic has ongoing development contracts with the US government to develop a third-generation smallpox vaccine, IMVAMUNE(R: 72.76, -0.50, -0.68%). Bavarian Nordic has supplied several other governments with smallpox vaccines.

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