Mecasermin rinfabate
| Combination of | |
|---|---|
| IGF-1 | Growth factor |
| IGFBP-3 | Binding protein |
| Clinical data | |
| Trade names | Iplex |
| AHFS/Drugs.com | Monograph |
| Routes of administration |
Injection |
| ATC code | |
| Identifiers | |
| ChemSpider |
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Mecasermin rinfabate (INN, USAN) (brand name Iplex), also known as rhIGF-1/rhIGFBP-3, is a drug consisting of recombinant human insulin-like growth factor 1 (IGF-1) and recombinant human insulin-like growth factor binding protein-3 (IGFBP-3) which is used for the treatment of amyotrophic lateral sclerosis (Lou Gehrig's disease).
It is similar in action to mecasermin, but with fewer side effects (such as hypoglycemia).
Mecasermin rinfabate was developed by INSMED corporation for the treatment of growth failure in children with severe primary IGF-I deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Due to a patent settlement, Iplex is being taken off the market for short stature related indications. However, Iplex is being studied as a treatment for other several serious medical conditions.
On March 11, 2009 the FDA announced that mecasermin rinfabate would be made available to Americans with amyotrophic lateral sclerosis, more commonly known as Lou Gehrig's disease, as a part of a clinical trial. The drug is currently available in Italy for this condition.
Iplex was investigated in a Phase II clinical study at the University of Rochester School of Medicine, with funding provided by the Muscular Dystrophy Association and the National Institutes of Health. This Phase II program studied the safety and tolerability of once-daily, subcutaneous injection of Iplex in patients with MMD. While patients with MMD showed significant increases in total muscle weight, testosterone levels, and LDL levels, and significant decreases in triglyceride and HDL levels, functional assays such as grip strength and walk tests did not show improvement.
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