Ratiopharm unit and Neose initiate Ph I study

BioGeneriX AG, a member of the German Ratiopharm Group of companies, and Neose Technologies of the USA say that the second Phase I clinical trial of GlycoPEG-GCSF, a long-acting granulocyte colony stimulating factor (GCSF), has been initiated. This trial in healthy volunteers will compare a single, subcutaneously administered, fixed dose of GlycoPEG-GCSF versus the approved fixed dose of Amgen's Neulasta (pegfilgrastim), the only currently-marketed, long-acting GCSF. GlycoPEG-GCSF is being developed for the treatment of neutropenia associated with cancer chemotherapy.

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 I 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' chief executive. Global sales in the GCSF category were around $4.0 billiion in 2005.