Ipsen reveals positive findings with rhGH and Increlex

France's Ipsen has announced preliminary results from a Phase II open-label clinical trial (MS316 study) that evaluates the co-administration of recombinant human growth hormone (rhGH) and recombinant human insulin-like growth factor-1 (rhIGF-1) in two separate daily injections as a potential treatment for children with otherwise unexplained short stature associated with low IGF-1 levels.

Ipsen also presented results from a long-term study of rhIGF-1 (study 1419) in patients with severe primary insulin-like growth factor deficiency (sPIGFD) that demonstrated that long-term twice daily therapy with rhIGF-1 improved the adult and near adult heights of extremely short patients with sPIGFD. The data from these two studies were presented along with posters on rhIGF-1 (Increlex, mecasermin [rDNA origin] injection) at the 8th Joint Meeting of the Lawson Wilkins Pediatric Endocrine Society / European Society for Pediatric Endocrinology in New York, USA
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These studies were performed under Investigational New Drug application protocols and the co-administration of rhGH and rhIGF-1 is not an approved administration regimen for Increlex. At present, Increlex is marketed in the USA and other countries throughout the world for the treatment of growth failure in children with severe Primary IGFD using twice daily injections.

'The structuring of its US platform in 2008 enabled Ipsen to build a fully fledged commercial presence in the USA but also to gain access to a promising pipeline. The Group intends to capitalize on its unique growth disorders and endocrinology franchise. The interim data presented at the LWPES/ ESPE meeting validate ongoing investigations and we look forward to continuing our research progress with our partners on this effort,' said Jean-Luc Belingard, chief executive of Ipsen. 'Ipsen Group remains fully committed to furthering its endocrinology research and product development in support to its fastest growing franchise in this highly-specialized therapeutic area,' he added.