Methods for inducing selective apoptosis

Abstract

Provided herein are methods for cell therapy by modifying transfused cells to express an inducible caspase 9 protein, so that the cells may be selectively killed if the patient experiences dangerous side effects. Provided also within relates in part to methods for preventing or treating Graft versus Host Disease by modifying T cells before administration to a patient, so that they may be selectively killed if GvHD develops in the patient.

1 - 23 . (canceled) 
     
     
         24 . A composition consisting of AP1903 in a 25% solution of polyethylene glycol-15-hydroxystearate. 
     
     
         25 . The composition of  claim 24  wherein said AP1903 is at a concentration of 5 mg/ml in said 25% solution. 
     
     
         26 . A method of preparing a composition for administration to a human patient comprising making a 5 mg/ml solution of AP1903 in a 25% solution of polyethylene glycol-15-hydroxystearate to produce an AP1903 solution. 
     
     
         27 . The method of  claim 26  further comprising storing the AP1903 solution under refrigeration. 
     
     
         28 . A method of preparing an AP1903 composition for administration to a human patient, said method comprising the following steps in the order stated:
 (a) removing a refrigerated AP1903 solution from refrigeration, said AP1903 solution consisting of AP1903 in a 25% solution of polyethylene glycol-15-hydroxystearate;   (b) storing the AP1903 solution overnight at approximately 21 degrees ° C.; and   (c) producing a diluted solution by diluting an aliquot of the AP1903 solution containing a dose of AP1903 for the human patient in 100 ml of 0.9% normal saline.   
     
     
         29 . The method of  claim 28  further comprising administering the diluted solution to the human patient within 30 minutes of said producing step. 
     
     
         30 . A method of administering AP1903 to a human patient comprising:
 administering to a human patient AP1903 in solution at a dose of 0.4 mg/kg via intravenous infusion.   
     
     
         31 . The method of  claim 30 , wherein said dose is diluted in 0.9% normal saline before said administering. 
     
     
         32 . The method of  claim 31 , wherein said dose is diluted in 100 ml of 0.9% normal saline before said administering. 
     
     
         33 . The method of  claim 30 , wherein the AP1903 in solution is made by diluting a composition containing AP1903 in a 25% solution of polyethylene glycol-15-hydroxystearate in 100 ml of 0.9% normal saline before said administering. 
     
     
         34 . The method of  claim 33 , wherein said composition consists of 5 mg/ml AP1903 in a 25% solution of polyethylene glycol-15-hydroxystearate.