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BioGeneriX and Neose Technologies, today announced the initiation of dosing in a Phase 2 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
MANNHEIM, Germany & HORSHAM, PA, USA | June 23, 2008 | BioGeneriX AG, a member of the ratiopharm Group of companies, and Neose Technologies, Inc. (NasdaqGM:NTEC - News) today announced the initiation of dosing in a Phase 2 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.
The multi-country, randomized, double-blind, controlled trial will enroll up to 200 breast cancer patients receiving four cycles of myelosuppressive CTX chemotherapy (doxorubicin 60 mg/m2 /docetaxel 75 mg/m2). The study will compare three doses of GlycoPEG-GCSF to the standard, fixed 6 mg 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 1, defined as grade 4 neutropenia (ANC < 0.5 x 109/L) and the incidence of febrile neutropenia in cycles 1, 2, 3 and 4 and across all cycles.
"In our Phase 1 program of over 50 subjects, we reported a 30% greater increase in neutrophil count and a 60% greater bioavailability for GlycoPEG-GCSF versus Neulasta at similar doses,” said George J. Vergis, Ph.D., Neose president and chief executive officer. “This Phase 2 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.”
"Based on encouraging preclinical and Phase 1 data, we are pleased to move GlycoPEG-GCSF into Phase 2 development,” said Dr. Karl Heinz Emmert, BioGeneriX chief scientific officer. “We expect completion of this Phase 2 study during the first half of 2009.”
About G-CSF and Neutropenia
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 exceeded $4 billion in 2007. 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.
About BioGeneriX AG
BioGeneriX AG was founded in June 2000 to develop biopharmaceutical drugs with known modes of action and established drug markets. With its internal resources and a large network of strategic partners and service providers, BioGeneriX develops a high-quality biotech portfolio for marketing and distribution by its parent company and global partners. For more information, visit its website at www.biogenerix.com.
About the ratiopharm Group
ratiopharm is Europe's leading generics producer and in its home country Germany the top selling and most commonly prescribed pharmaceutical brand. The company produces high quality medicines and sells them at low prices. By doing so, it contributes to cost containment in the healthcare sector. With over 700 medicines, available exclusively from pharmacies, it has one of the widest product ranges in the business. ratiopharm sells 472 million pack units every year, meeting the needs of virtually all areas of medicine, from allergies to circulation problems and from gastroenteritis to toothaches. Founded in 1974, ratiopharm is now bringing its business model and experience to international markets. It is already active in 24 countries. In 2006, ratiopharm generated worldwide revenues of 1.7 billion Euros, of which 800 million Euros were from sales in Germany. For more information, visit its website at www.ratiopharm.com.
About Neose Technologies, Inc.
Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market. The lead candidates in its pipeline, GlycoPEG-GCSF for chemotherapy-induced neutropenia, and the GlycoPEGylated hemostasis compounds Factor VIIa, Factor VIII, and Factor IX, target markets with aggregate 2006 sales of approximately $8 billion. For more information, please visit www.neose.com.
SOURCE: BioGeneriX Ag and Neose Technologies, Inc. |
