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    DGAP-News  416  0 Kommentare NEOVACS SCIENTIFIC ADVISORY BOARD ENDORSES COMPANY'S UPDATED IFNα-KINOID DEVELOPMENT PLAN - Seite 2


    in Europe, Latin-America and Asia. The SAB also made recommendations
    regarding trial protocol and recruitment criteria, which have been
    discussed with the Clinical Lupus Board and integrated into the study
    design. This Phase IIb study is expected to begin mid 2015. A second Phase
    I/IIa trial for SLE using IFNα-Kinoid in the U.S. is
    planned to commence by early 2016.

    Extension of IFNα-Kinoid development program to include dermatomyositis

    As a result of the positive safety profile and encouraging results from
    IFNα-Kinoid thus far, the SAB recommended broadening Neovacs' scope of
    IFNα-Kinoid treatment targets to dermatomyositis, another indication where
    a positive IFNα signature plays a decisive role. Clinical trials conducted
    in this indication further validate the scientific consensus in this
    matter.

    Dermatomyositis (DM) is a severe, sometimes fatal, disease affecting mainly
    children (60 percent of the patient population), with significant unmet
    medical need as no biological treatment has been registered to date in this
    indication. Dermatomyositis is considered an orphan disease both in North
    America and in Europe, where there are fewer than 20,000 affected patients
    respectively.

    Following this recommendation, Neovacs is working to rapidly integrate DM
    in both adult and pediatric patients into the Company's clinical
    development plan for IFNα-Kinoid. Because of the recognized orphan status
    of DM, Neovacs estimates that clinical development of active immunotherapy
    in this indication could be considerably shortened (phase III trials may
    not be necessary), with the potential to bring a treatment to market in a
    few years.

    Final Review of TNF-Kinoid Phase IIb results in Rheumatoid Arthritis (RA)

    The final outcome of the February Neovacs' SAB meeting was the analysis of
    the Company's TNF-Kinoid development plan that led to the December 2014
    Phase IIb results in RA. Findings included:

    - Preclinical results of TNF-Kinoid in a mouse model of arthritis showed
    significant binding and neutralizing antibody responses, and clinical
    efficacy nearly identical to the comparator (infliximab), justifying
    fully the start of clinical development (Delavallée et al., 2009
    Arthritis Research & Therapy)

    - The results of the Phase IIa RA trial in 40 patients demonstrated a
    good tolerance of the product, as well as a significant increase of
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    DGAP-News NEOVACS SCIENTIFIC ADVISORY BOARD ENDORSES COMPANY'S UPDATED IFNα-KINOID DEVELOPMENT PLAN - Seite 2 DGAP-News: Neovacs S.A. / Key word(s): Miscellaneous NEOVACS SCIENTIFIC ADVISORY BOARD ENDORSES COMPANY'S UPDATED IFNα-KINOID DEVELOPMENT PLAN 04.03.2015 / 08:00 --------------------------------------------------------------------- PRESS RELEASE …