Proprietary Protein Platform
IPLEX(TM) is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug, approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency, is currently being investigated in Myotonic Muscular Dystrophy (MMD) and Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's disease.
A Phase 2 trial of IPLEX(TM) in MMD is on-going and a substantial portion of the external costs associated with the study are expected to be covered by an approximately $2.1 million grant awarded to Insmed by the Muscular Dystrophy Association in late 2007.
MMD Phase 2 trial at-a-glance:
- All sites have been initiated, received Investigational Review Board approvals and are actively recruiting trial participants.
- The trial is currently more than 50 percent enrolled.
- The trial is on target to complete enrollment by mid-year 2008.
- Interim data analysis scheduled for fourth quarter 2008.
IPLEX(TM) is also in use as part of an Expanded Access Program (EAP) in partnership with the Italian Ministry of Health for the treatment of ALS. Since early 2007, the EAP has grown to include 20 physicians, and approximately 90 subjects have been enrolled into the program to date with additional subjects being enrolled as the program progresses. IPLEX(TM) continues to be safe and well tolerated in the subject population. During the first quarter of 2008, the EAP generated $2.3 million in cost recovery revenue for Insmed, compared to $0.7 million during the same period last year, and $2.0 million in the fourth quarter of 2007.
