Executives and scientists from U.S. Bioscience Inc. met with theFood and Drug Administration on Monday to discuss thecompany's application for marketing approval of Ethyol,according to Robert Kriebel, senior vice president of financeand administration.
An FDA advisory committee in January recommended that theFDA deny the company's application for Ethyol as a treatmentto protect healthy cells from chemotherapy. The committeequestioned the clinical trials data and study design.
Monday's meetings were "cordial and constructive," Kriebelsaid. He declined to provide details.
The company had sought approval for use of Ethyol forprotection of chemotherapy patients who are at risk for serioustoxicities from conventional doses of cyclophosphamide (CP) orCP in combination with cisplatinum. In February, Kriebel toldBioWorld the company would use the FDA meetings to decidewhether to pursue a narrow label indication for Ethyol as atreatment to reduce hematological toxicity associated with CP,particularly hospitalization from neutropenic fever and sepsis.
To facilitate approval of a narrow label indication, the WestConshohocken, Pa., company has reopened its pivotal clinicaltrial of 147 ovarian cancer patients.
The stock (NASDAQ:UBS) closed unchanged at $17 on Monday.
-- Steve Usdin BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.