The trial will evaluate the safety, pharmacokinetics and pharmacodynamics of GlycoPEG-GCSF versus Neulasta. The phase I trial is designed to evaluate subcutaneous administration of GlycoPEG-GCSF (G-CSF).
“We are pleased to have our GlycoPEG-GCSF enter phase I as the second Neose protein to enter human clinical trials this year,” said George Vergis, Neose president and CEO.
G-CSF is prescribed to stimulate the production of neutrophils, and is approved for sale in major markets around the world for the treatment of neutropenia associated with myelosuppressive chemotherapy. Worldwide sales in the G-CSF category were approximately $4 billion in 2005.
Neutropenia is a severe reduction in the number of neutrophils (mature white blood cells) in the circulating blood, commonly associated with cancer chemotherapy. Patients with neutropenia are at increased risk of developing serious infection. If not treated promptly, neutropenia can be life-threatening.