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Bavarian Nordic Provides Update on its Universal RSV Vaccine | ||
By: Nasdaq / GlobeNewswire - 21 Sep 2017 | Back to overview list |
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COPENHAGEN, Denmark, September 21, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced initial 6 month follow-up data from the Phase 2 trial of MVA-BN ® RSV, a universal vaccine candidate designed to induce protective immune responses against both subtypes (A & B) of the respiratory syncytial virus (RSV). The randomized, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of the recombinant vaccine in 421 healthy adults aged 55 and older. The subjects were enrolled into four active arms of the study, which examined the effects of both a high (5x10 8 ) and low (1x10 8 ) dose, administered as either one or two vaccinations (day 0, 28) and compared to a placebo arm. At 6 month follow up, a persistent antibody response against multiple RSV targets can still be observed. Also announced today are the Company's updated clinical plans for the RSV vaccine, which will now include a human challenge study. Anticipated to initiate recruitment in the second half of 2018 the placebo-controlled study will explore the protective effects of MVA-BN RSV. Bavarian Nordic intends to use evidence from the challenge study to assist in the planning and design of late phase RSV studies as well as demonstrating early evidence regarding efficacy of MVA-BN RSV in preventing disease in healthy volunteers subsequently exposed to live RSV. Bavarian Nordic will partner with a global CRO to develop a novel and differentiated approach to the RSV challenge model. Previous attempts at RSV challenge studies have historically been seen as lacking in sufficient measurable outcomes, which may be associated with the relatively low virulence of the virus administered to volunteers. The CRO has developed a new primary isolate of RSV which, in infectivity assays, has demonstrated a degree of virulence and pathogenicity more commonly associated with circulating, wild-type strains. This new model will potentially allow Bavarian Nordic to more accurately assess the protective benefits of its vaccine when confronted with a virulent RSV infection. "We are very happy to report this data, once again demonstrating the durability of our vaccine for up to 6 months," said Paul Chaplin, President and CEO of Bavarian Nordic, "Announcing the development of a more virulent RSV human challenge model creates the potential to gain efficacy data of our RSV vaccine prior to initiating the pivotal Phase 3. The global CRO is an ideal partner and a leader in the field having previously been successful in developing a virulent influenza challenge model."
About Bavarian Nordic
Forward-looking statements
Contacts
Seth Lewis
Company Announcement no. 27 / 2017
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Bavarian Nordic A/S via GlobeNewswire
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