Method for achieving desired glial growth factor 2 plasma levels

Abstract

The present invention relates to administering glial growth factor 2 (GGF2) to a patient in need thereof, to achieve serum levels of GGF2 within a desired therapeutic window determined based on the disease or disorder afflicting the patient. In a particular embodiment, the patient is suffering from a disease or disorder associated with reduced levels of myelination and the GGF2 is administered to promote myelination in the patient.

1 - 18 . (canceled) 
     
     
         19 . A method for broadening the therapeutic dose range for glial growth factor 2 (GGF2) when GGF2 is used to facilitate myelination, the method comprising:
 selecting a subject with a disease or disorder associated with reduced levels of myelination;   administering GGF2 and a Mek1/Erk pathway inhibitor to the patient, and, whereby GGF2-mediated myelination is occurs at higher doses of GGF2 than would occur in the absence of administering the Mekl/Erk pathway inhibitor.   
     
     
         20 . The method of  claim 19 , wherein the administering step comprises administering an amount of GGF2 that elicits a plasma level above about 0.01 nM GGF2. 
     
     
         21 . The method of  claim 20 , wherein the administering step comprises administering an amount of GGF2 that elicits a plasma level above 0.01 nM GGF2. 
     
     
         22 . The method of  claim 19 , wherein the administering step comprises administering an amount of GGF2 greater than about 500 ng of GGF2 per kg of body weight. 
     
     
         23 . The method of  claim 22 , wherein the administering step comprises administering an amount of GGF2 greater than 500 ng of GGF2 per kg of body weight. 
     
     
         24 . A method for determining if an amount of GGF2 is a therapeutically effective amount for promoting myelination, the method comprising:
 providing a subject receiving GGF2 therapy; and   measuring c-Jun protein levels in the subject, whereby an increase in c-Jun relative to baseline c-Jun levels indicates that the amount of GGF2 is near a maximum threshold of therapeutic efficacy for promoting myelination.   
     
     
         25 . The method of  claim 24 , further comprising decreasing the amount of GGF2 administered to the subject if c-Jun levels are increased relative to baseline c-Jun levels. 
     
     
         26 . The method of  claim 24 , further comprising maintaining the amount of GGF2 administered to the subject if c-Jun levels remain at the baseline c-Jun levels. 
     
     
         27 - 28 . (canceled)