By a News Reporter-Staff News Editor at Biotech Week -- Research findings on Immunology are discussed in a new report. According to news originating from Hayward, California, by NewsRx correspondents, research stated, "Type I interferons (IFNs) are implicated in the pathogenesis of systemic sclerosis (SSc). MEDI-546 is an investigational human monoclonal antibody directed against the type I IFN receptor."
Our news journalists obtained a quote from the research from MedImmune, "This Phase 1 study evaluated the safety/tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of single and multiple intravenous doses of MEDI-546 in adults with SSc. Subjects (>= 18 years) with SSc were enrolled in an open-label, dose-escalation study to receive single (0.1, 0.3, 1.0, 3.0, 10.0, or 20.0 mg/kg), or 4 weekly intravenous doses (0.3, 1.0, or 5.0 mg/kg/week) of MEDI-546. Subjects were followed for 12 weeks. Safety assessments included adverse events (AEs), laboratory results, and viral monitoring. Blood samples were collected from all subjects for determination of PK, presence of anti-drug antibodies (ADAs), and expression of type I IFN-inducible genes. Of 34 subjects (mean age 47.4 years), 32 completed treatment and 33 completed the study. Overall, 148 treatment-emergent AEs (TEAEs) were reported (68.9% mild, 27.7% moderate). TEAEs included one grade 1 infusion reaction (5.0 mg/kg/week multiple dose). Of 4 treatment-emergent serious AEs (skin ulcer, osteomyelitis, vertigo, and chronic myelogenous leukemia (CML)), only CML (1.0 mg/kg/week multiple dose) was considered possibly treatment-related. MEDI-546 exhibited non-linear PK at lower doses. ADAs were detected in 5 subjects; no apparent impact on PK was observed. Peak inhibition of the type I IFN signature in whole blood was achieved within 1 day and in skin after 7 days."
According to the news editors, the research concluded: "The safety/tolerability, PK, and PD profiles observed in this study support further clinical development of MEDI-546."
For more information on this research see: Dose-escalation of human anti-interferon-alpha receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study. Arthritis Research & Therapy, 2014;16(1):594-605. Arthritis Research & Therapy can be contacted at: Biomed Central Ltd, 236 Grays Inn Rd, Floor 6, London WC1X 8HL, England. (BioMed Central - www.biomedcentral.com/; Arthritis Research & Therapy - arthritis-research.com/)
The news correspondents report that additional information may be obtained from A. Goldberg, MedImmune, Hayward, CA, United States. Additional authors for this research include T. Geppert, E. Schiopu, T. Frech, V. Hsu, R.W. Simms, S.L. Peng, Y.H. Yao, N. Elgeioushi, L.D. Chang, B. Wang and S. Yoo (see also Immunology).
Keywords for this news article include: Antibodies, Hayward, Therapy, Genetics, Cytokines, Sclerosis, California, Immunology, United States, Blood Proteins, Immunoglobulins, Interferon-alpha, Interferon Type I, Biological Factors, Adverse Drug Reaction, North and Central America, Intercellular Signaling Peptides and Proteins
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