Baxter presents Kiovig trial results

Baxter International has announced the preliminary results of a phase I/II clinical study of Kiovig [immune globulin intravenous (human)], known out of Europe as Gammagard Liquid, with Enhanze Technology enabled administration.

The drug was given as a full monthly dose via a single site to primary immunodeficiency patients.

Individuals in the trial received 25.5 to 61.2 grammes of the compound subcutaneously, with infusion rates of between 120 ml/hr and 300 ml/hr – which are comparable to the infusion rates seen in intravenous administration.

Average bioavailability of the combination was 92 per cent of monthly intravenous administration.

Kiovig is indicated for the treatment of primary immunodeficiency disorders related to humoral immunity defects, such as ongenital X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and common variable immunodeficiency.

Hartmut J Ehrlich, vice-president of global research and development for bioscience at Baxter, said: “These early results are the latest demonstration of Baxter’s ongoing commitment to innovation and, in particular, to advancing the science of IGIV therapy.”

He added that the company is planning to start a key phase III trial of Gammagard Liquid with Enhanze Technology, pending dialogue with the relevant regulatory bodies at the start of 2009.

The European Medicines Agency issued marketing authorisation for Kiovig as a replacement therapy in primary immunodeficiency disorders, myeloma or chronic lymphocytic leukaemia in January 2006.