Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Ratiopharm Group subsidiary BioGeneriX and Neose Technologies has begun the second phase I clinical trial of GlycoPEG-GCSF, for the treatment of neutropenia associated with cancer chemotherapy.
Subscribe to our email newsletter
The trial in healthy volunteers will compare a single, subcutaneously administered, fixed dose of GlycoPEG-GCSF versus the approved fixed dose of Amgen’s Neulasta, the only currently marketed long-acting GCSF.
Interim results from the ongoing Phase I clinical trial show a dose-dependent response for GlycoPEG-GCSF versus Neulasta with no reported serious adverse events. The first phase 1 study is a single-dose, single-blind, randomized, ascending-dose study, with subjects randomized to receive either GlycoPEG-GCSF or Neulasta.
“The results of our first Phase I study to date support our belief that GlycoPEG-GCSF is an attractive candidate to enter the large and rapidly growing G-CSF category,” said Elmar Schaefer, BioGeneriX’s CEO.