U.S. Bioscience Inc. said Thursday that it filed an amendment to itsnew drug application on Ethyol, seeking a narrower approval focusfor the cytoprotective agent.

The West Conshohocken, Pa., company's amendment focuses onEthyol's ability to protect against the cumulative renal toxicitiesassociated with cisplatin, and cumulative hematologic toxicitiesassociated with cisplatin and cyclophosphamide. An FDA advisorycommittee in December recommended against approving Ethyol forprotection against certain toxicities of chemotherapy in ovariancancer patients.

Robert Kriebel, U.S. Bioscience's senior vice president, finance andadministration, told BioWorld the cumulative effect of renaltoxicities was one of the original endpoints. The company expects areview of the amendment mid-year.

U.S. Bioscience also released two other pieces of news Thursday. Itsaid it was granted a worldwide exclusive license from the NationalInstitutes of Health to two AIDS compounds, FddA and its activemetabolite, FddI. FddA is a purine-based reverse transcriptaseinhibitor that the company said compared favorably to AZT inpreclinical studies, and did not show cross-resistance to AZT, ddi orddC.

Finally, the company said it received a product license to marketHexalen (altretamine) as a second-line treatment for advancedovarian cancer in the U.K.

Kriebel said U.S. Bioscience will take advantage of opportunities tosell Hexalen (and NeuTrexin, which was approved in some Europeancountries last week), but plans to get a marketing partner for bothdrugs.

U.S. Bioscience's stock (AMEX:UBS) was up 25 cents Thursday,closing at $2.69. _ Jim Shrine

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