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DNA Helps Reunite Children With Their Families
Of the 600,000-800,000 people trafficked across international borders each year, 50 percent are under 17. It is estimated that by 2010, human trafficking will be the No. 1 crime worldwide.
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Study Shows Januvia(TM) (sitagliptin) Offered Significant Blood Sugar-Lowering Efficacy In Combination With Insulin In Type 2 Diabetes
A new investigational study presented at the American Diabetes Association (ADA) 69th Annual Scientific Sessions showed that "Januvia" (sitagliptin), when added to ongoing insulin therapy with or without metformin, significantly improved blood sugar control.[i] Applications to use "Januvia" and "Janumet"* (sitagliptin/metformin) in combination with insulin have been accepted for review by the European Medicines Agency (EMEA) and by the U.S. Food and Drug Administration (FDA) and are currently under review.
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Elsevier's PharmaPendium Introduces The FDA Classic Collection
PharmaPendium, Elsevier"s online re for authoritative preclinical, clinical and post-marketing drug information, has significantly expanded its coverage of US Food and Drug Administration (FDA) approval documents with the launch of the FDA Classic Collection. This collection contains all available historical FDA approval documents up to and including those issued in 1991 - all indexed and made searchable for the first time in history. With the addition of the FDA Classic Collection, PharmaPendium has become the only integrated, searchable of all FDA drug approval documents.
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MorphoSys Reports Filing For Phase 1b/2a Trial For Its Lead Program MOR103 In Rheumatoid Arthritis

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that the Company has submitted an application for the authorization of a phase 1b/2a clinical study in patients with active rheumatoid arthritis (RA) for its lead drug MOR103, a fully human HuCAL-derived monoclonal antibody directed against Granulocyte Macrophage-Colony Stimulating Factor. The trial, which will be conducted in multiple centers in several European countries, is expected to enroll 135 patients in total beginning in the second half of 2009. Additionally, the Company today reported positive results from the phase 1 clinical study for MOR103 in healthy volunteers. The results of this study indicate that MOR103 is generally safe and well tolerated at all doses administered. "We are pleased to advance the clinical development of this promising compound into a phase 1b/2a clinical trial to further evaluate safety and tolerability as well as clinical activity in RA patients," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys. "In combination with the attractive preclinical profile the results we have seen in the phase 1 trial support our plans to develop MOR103 as a safe and efficacious drug for the treatment of inflammatory disorders. In addition to the excellent characteristics the antibody has shown so far with regard to affinity, specificity and stability, we have been able to demonstrate a robust serum half-life in humans." The completed phase 1 trial was designed as a randomized, double-blind, placebo controlled single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of MOR103 in healthy volunteers. In total, 63 volunteers received ascending doses of MOR103 up to a concentration of 3 mg/kg or placebo in seven dose cohorts via intravenous infusion. No maximum tolerated dose (MTD) was reached in the study. Analysis of the pharmacokinetic properties of MOR103 showed a serum half-life typical of a fully human antibody which could translate into a competitive dosing regimen. The overall safety, tolerability and pharmacokinetic properties of MOR103 provide a solid foundation for the Company"s development plans, including the forthcoming Phase 1b/2a study in patients. MorphoSys will present at today"s 4th Annual Piper Jaffray Europe Conference at 08:30 am BST (09:30 am CET). The presentation as well as live and archived webcast of the presentation will be provided at http://www.morphosys.com. MorphoSys AG


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