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NovImmune Successfully Completes NI-0801 Phase I Clinical Study
Posted by: admin in Pharmacy Drugs on September 01st, 2009
NovImmune, an immunology-focused biotech company
dedicated to the development of therapeutic monoclonal antibodies, announced the
successful completion of the first phase I clinical study with its fully human monoclonal antibody
NI-0801 targeting the chemokine IP-10 (CXCL10) in healthy volunteers. The randomized, doubleblinded,
placebo controlled, single centre, phase I study of escalating single intravenous doses of
NI-0801 in healthy volunteers (study NI-0801-01) demonstrated that NI-0801 is well tolerated at
doses up to and including 20mg/kg.
Chemokines are a group of low molecular weight proteins that induce the chemotaxis of different
leukocytes to sites of injury or infection. IP-10 is constitutively expressed at low levels in thymic,
splenic and lymph node stroma tissues, but its expression can be induced on a variety of cell types
including endothelial cells, keratinocytes, fibroblasts, monocytes and neutrophils. IP-10 not only
mediates leukocyte recruitment, but also drives T-cell proliferation upon antigenic stimulation.
Cell migration in response to chemoattractants requires the retention of IP-10, which is also true for
all other chemokines, in the vicinity of the site of inflammation to make sure cells are recruited
where they are needed.
IP-10 expression at sites of inflammation, leads to local accumulation of specialized cells responsible
for the inflammation process in a number of different autoimmune conditions including psoriasis,
multiple sclerosis, ulcerative colitis, rheumatoid arthritis, atherosclerosis, liver fibrosis and
sarcoidosis. Dr Penelope Ward, Chief Medical Officer commented that ’since increased IP-10
(CXCL10) levels correlate with disease severity, an ability to neutralize its effects with a target
specific monoclonal antibody offers a promising strategy for the treatment of diseases such as liver
fibrosis and lupus, for which therapeutic options are currently limited.’
NI-0801 is well aligned within NovImmune’s overall expertise and strategy in the field of chemokines
to develop potential future therapeutics. Along these lines NovImmune is very happy to have
become a member of the European F6 consortium “Innovative Chemokine-based Therapeutic
Strategies for Autoimmunity and Chronic Inflammation” (INNOCHEM). Dr Marie Kosco-Vilbois, CSO at
NovImmune, commented that ‘it is a great pleasure and opportunity for NovImmune to be part of a
European group of Excellence in the field of future therapeutic applications of the ‘chemiome’,
where eminent academic and industrial partners cooperate to translate chemokine biology into
effective therapeutics.’
Source
NovImmune SA