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Advaxis completes patient recruitment in ADXS11-001 phase II study for cervical dysplasia

October 06, 2017

Phase 1 Single-Dose Clinical Trial of IMO-3100 in Healthy SubjectsStudy DesignIMO-3100 was administered by subcutaneous injection at five escalating dose levels: 0.04, 0.08, 0.16, 0.32, and 0.64 mg/kg. The primary objective was evaluation of safety and tolerability. Secondary objectives were to characterize the pharmacokinetics of IMO-3100 and to assess the pharmacodynamic mechanism of action using peripheral blood mononuclear cells (PBMCs). Six healthy subjects were enrolled at each dose level, plus six placebo subjects. The trial was conducted at a single U.S. site.

Study Results

IMO-3100 was well tolerated at all dose levels There were no serious adverse events reported and all adverse events were grade 1 Mild injection site reactions were the most frequent adverse event (65%) Proof of target engagement was demonstrated by inhibition of TLR7- and TLR9-mediated cytokine induction in PBMCs isolated from study subjects after IMO-3100 treatment at dosages of 0.32 and 0.64 mg/kg The inhibition of cytokine induction was dependent on dose of IMO-3100 administered Cytokines inhibited include TNF-?, IL-1??, IL-6, IL-2R, IL-12, IL-10, IL-8, MIP-1? and ??, IFN- ? and RANTES Selected cytokines remain suppressed for up to 5 days in IMO-3100-treated subjects There was no evidence of cytokine inhibition in PBMCs isolated from placebo-treated subjects

Source: Idera Pharmaceuticals, Inc.