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news.BioGeneriX and Neose Technologies have reported positive data from two Phase I clinical studies of GlycoPEG-GCSF for the treatment of neutropenia associated with myelosuppressive chemotherapy.
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The first Phase I study evaluated a randomized, weight-based, single ascending dose of GlycoPEG-GCSF compared to Neulasta in 53 healthy subjects. This trial shows that single doses of GlycoPEG-GCSF demonstrated potent stimulation of neutrophils and mobilization of peripheral blood progenitor cells. Single doses of drug up to 100 mcg/kg, were generally well-tolerated with no serious adverse events.
The second Phase I study evaluated a 6mg dose of GlycoPEG-GCSF versus a 6mg dose of Neulasta in 36 healthy subjects. This study shows that GlycoPEG-GCSF demonstrated potent stimulation of neutrophils and mobilization of peripheral blood progenitor cells and demonstrated an approximately 30% greater absolute neutrophil count response versus Neulasta. Adverse events were comparable to Neulasta, and there were no discontinuations due to adverse events.
George Vergis, Neose president and CEO, said: “We are encouraged by the emerging product profile for our GlycoPEG-GCSF candidate. We look forward to determining whether the intriguing increases in absolute neutrophil count and bioavailability seen in the Phase I studies will continue to be evident in patients receiving chemotherapy in Phase II.”