U.S. Bioscience Inc. (UBS) said Wednesday that it filed an amendednew drug application (NDA) to the FDA for Ethyol, a drug designed toreduce the side effects of chemotherapy treatment.An FDA advisory panel in February 1992 refused to recommendEthyol (amifostine) approval without additional data showing itprevents or decreases toxicities caused by chemotherapeutic agents,and that Ethyol doesn't decrease the anti-tumor effect of chemotherapydrugs. The company's stock fell 44 percent ($13.75) the next tradingafter the panel's announcement, to $17.75.The West Conshohocken, Pa., company's amended NDA, in responseto the questions raised by the FDA in December 1993, includes furtheranalysis of a pivotal trial in ovarian cancer involving 242 patients, 121of whom were accrued in the initial segment of the trial and the restafter the FDA's 1992 request for a larger patient population.The updated information also was recently provided to the Committeefor Proprietary Medicinal Products in Europe. UBS originally filed forEuropean marketing approval in September 1992."Obviously, we feel it's a good submission and supportive of theapplication," Robert Kriebel, UBS' senior vice president, finance andadministration, told BioWorld. "We're not going to comment on theindication. That's something that would be negotiated as a last eventwith the FDA."Ethyol is administered prior to administration of chemotherapeuticagents such as cyclophosphamide and cisplatin to protect healthy cells,but not tumor cells from toxicities. It was first looked at as part of aU.S. Army research project to identify a radiation-protection drug, andwas selected as the most active compound from more than 4,400 thatwere screened, UBS said.Ethyol currently is being tested in Phase II trials for breast and lungcancers, Kriebel said, and in a trial as a selective protector of healthytissues in head and neck cancer patients receiving radiation therapy.Positive results of the pivotal studies in ovarian cancer were reported inMay at the annual meeting of the American Society of ClinicalOncologists in Dallas.A University of Pennsylvania Cancer Center study evaluated twogroups of patients, a treatment group receiving Ethyol and the twochemotherapy drugs, and a control group receiving only thechemotherapy drugs. Only 9 percent of the treatment group droppedout due to toxicities compared to 39 percent in the control group, andthe treatment group fared better in a number of other areas as well.The study also showed pretreatment with Ethyol did not reduce theantitumor efficacy of the chemotherapy drugs, and that survival wassimilar in the two groups."This study demonstrated that now we can protect against thecumulative toxicities of chemotherapy without reducing dosage orfrequency," John Glick, director of the cancer center, said at themeeting.U.S. Bioscience (AMEX:UBS) stock was up 50 cents Wednesday,closing at $6.63 per share. n
-- Jim Shrine
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