U.S. Bioscience hopes to meet with the Food and DrugAdministration during the week of Feb. 17 to discuss clinicaltrials to support resubmission of Ethyol, Barbara Scheffler,senior vice president for clinical and regulatory affairs, toldBioWorld on Tuesday.
As a starting point with the FDA, Scheffler said, the companyprobably would pursue use of the chemoprotective drug forreducing hematological toxicity associated withcyclophosphamide (CP). She said that the chemotherapy is usedto treat a variety of tumors, including ovarian, breast, andsmall cell lung cancer and lymphomas.
U.S. Bioscience will enlarge its ovarian cancer clinical trials to200 patients, as specified by the original study protocol, togather data in support of a broader indication that includesreducing other toxicities, including kidney, nerve and hearingtoxicities associated with CP when used with conventionaldoses of cisplatin, Scheffler said. In addition, the company isconducting trials of Ethyol with higher doses of cisplatin totreat metastatic melanoma. -- KH
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