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news.Neose Technologies has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for the initiation of a phase II human trial for a drug being developed for the treatment of anemia in adult cancer patients.
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Clinical trial supplies have been shipped, and patient recruitment has commenced for the trial of the drug, NE-180.
The phase II trial is designed as an ascending dose study to evaluate the safety, tolerability and dose response of NE-180 administered subcutaneously. The trial is expected to enroll up to 45 cancer patients receiving platinum-based chemotherapy. Fixed doses of NE-180 will be administered every three weeks with each cycle of chemotherapy for an expected duration of four chemotherapy cycles.
“The once-per-chemotherapy cycle dosing included in the study protocol is reflective of our preclinical findings and phase I results for NE-180. In addition to the current phase II trial, we plan to initiate our phase II renal program in 2007,” said George Vergis, Neose president and CEO.