1 February 2002, vol. 8, no. 1, pp. 24-29(6)
Frank J A; Richert N; Lewis B; Bash C; Howard T; Civil R; Stone R; Eaton J; McFarland H; Leist T
 Laboratory of Diagnostic Radiology Research, National Institutes of Health, Building 10, Room B1N256, 10 Center Drive MSC 1074, Bethesda, Maryland 20892, USA
 Clinical and Regulatory Affairs, Cephalon, Inc., 145 Brandywine Parkway, West Chester, Pennsylvania, USA
 Neuroimmunology Branch, National Institutes of Health, Building 10, Room B1N256, 10 Center Drive MSC 1074, Bethesda, Maryland, 20892, USA
The purpose of this open-label, crossover study was to determine the safety and efficacy of recombinant insulin-like growth factor-1 (rhIGF-1) using magnetic resonance imaging (MRI) and clinical measures of disease activity in seven multiple sclerosis (MS) patients.
Monthly clinical and MRI examinations were performed during a 24-week baseline and a 24-week treatment period with rhIGF-1.
The primary outcome measure was contrast enhancing lesion (CEL) frequency on treatment compared to baseline.
Secondary outcome measures included clinical and MRI measures of disease activity including: white matter lesion load (WMLL), magnetization transfer ratio (MTR), T1-Hypointensity volume, cervical spine cross-sectional area and proton magnetic resonance spectroscopic (MRS) imaging for determining regional metabolite ratios.
rhIGF-1 (Cephalon) was administered at a dose of 50 mg subcutaneously twice a day for 6 months. rhIGF-1 was safe and well tolerated with no severe adverse reactions.
There was no significant difference between baseline and treatment periods for any MRI or clinical measures of disease activity.
Although rhIGF-1 did not alter the course of disease in this small cohort of MS patients, the drug was well tolerated.
Further studies using rhIGF-1 alone
or in combination with other therapies may be of value because of the proposed
mechanism of action of this growth factor on the oligodendrocyte and remyelination.
© 2002 ingenta