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news.BioGeneriX, a member of the ratiopharm group of companies, and Neose Technologies have initiated dosing in a Phase II trial to evaluate the safety and efficacy of GlycoPEG-GCSF for the treatment of neutropenia associated with myelosuppressive chemotherapy. GlycoPEG-CGSF is being co-developed by the two companies.
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The multi-country, randomized, double-blind, controlled trial will enroll up to 200 breast cancer patients receiving four cycles of myelosuppressive CTX chemotherapy (doxorubicin 60mg/m2/docetaxel 75mg/m2).
The study will compare three doses of GlycoPEG-GCSF to the standard, fixed 6mg dose of Neulasta. Doses will be administered once per chemotherapy cycle for a maximum of four cycles.
In addition to safety and tolerability, the study will evaluate the duration of severe neutropenia in cycle one, defined as grade four neutropenia and the incidence of febrile neutropenia in cycles one, two, three and four and across all cycles.
George Vergis, president and CEO of Neose, said: “This Phase II study provides us the opportunity to determine whether this apparently enhanced product profile is also demonstrated in a larger study in a target patient population.”