Clinical Research Organization
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Clinical trial of Pegylated Filgrastim
Pegylated Filgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxypolyethylene glycol. Filgrastim, used in this clinical trial was obtained from bacterial fermentation of a strain of E. coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce Pegylated Filgrastim, a 20 kD monomethoxypolyethylene glycol molecule was covalently bound to the N-terminal methionyl residue of filgrastim. This was done in Bangladesh for the first time by Incepta Pharmaceuticals Ltd.
A comparative, randomized, double blind, single dose, cross over, Phase 1 PK/PD study of Pegylated Filgrastim (6 mg/0.6 ml) with Neulastim (6 mg/ 0.6ml) of Roche, Switzerland in healthy, adult, human subjects by subcutaneous injection was conducted by CRO Ltd. The sponsor of the clinical trial was Incepta Pharmaceuticals Ltd. The trial was monitored by Directorate General of Drug Administration, Bangladesh.
It is now commercialized inBangladesh as PEG-Filastin and is indicated to decrease the incidence of infection, as manifested by febrile neutropenia and in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. PEG-Filastin is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.