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Protalex Inc Announces Positive Interim Review of Phase 1b Trial Of PRTX-100 in Rheumatoid Arthritis By Independent Data Safety Monitoring Committee

Wednesday, 22 May 2013 08:30am EDT 

Protalex Inc announced that following a planned interim safety review by its independent Data Safety Monitoring Committee, the Company is continuing enrollment and increasing the dose for subjects in its multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (RA). The dose of PRTX-100 for subjects in the current treatment group (12.0 micrograms/kg) is eight times that of the initial starting dosage (1.5 micrograms/kg). PRTX-100 is a candidate drug incorporating a highly purified form of Staphylococcal Protein A. The primary objective of this Phase 1b study is to assess the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in subjects with active RA on methotrexate or leflunomide therapy. Secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters. The sequential dose-escalation phase is expected to enroll up to 40 subjects into five cohorts ranging from 1.5 micrograms/kg to 18.0 micrograms/kg of PRTX-100, or placebo, per protocol. 

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