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Clofarabine, Treatment for Relapsed Leukemia, Granted Fast Track Status

SAN ANTONIO--(BUSINESS WIRE)--Sept. 9, 2003--ILEX(tm) Oncology Inc. (Nasdaq:ILXO) announced today that the investigational compound clofarabine was granted fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory or relapsed acute lymphoblastic leukemia (ALL) in children. Based on this designation and ongoing discussions with the FDA, it is expected that the current Phase II trial investigating clofarabine in pediatric ALL will be pivotal for registration.

"The granting of fast track designation represents a significant milestone for ILEX and for the development of clofarabine," said ILEX CEO and President Jeff Buchalter. "Interim data from our Phase II trials of clofarabine in heavily pretreated children with acute leukemia have been very encouraging."

Designation as a fast track drug indicates that the FDA will facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need.

Investigators reported interim Phase II results recently at the American Society of Clinical Oncology meeting, which demonstrated an overall response rate of 28% for clofarabine in heavily pretreated children with ALL or acute myelogenous leukemia (AML). The overall response rate included complete remission, complete marrow remission in the absence of platelet recovery and partial remission.

ILEX initiated Phase II studies of clofarabine in children with refractory ALL and AML in 2002. These studies remain open and continue to enroll new patients.

Clofarabine was previously granted orphan drug designation for the treatment of adult and pediatric ALL and AML by the FDA. In the United States, orphan drug status guarantees seven years of market exclusivity for the orphan drug indication following the FDA's marketing approval.

About Clofarabine
Clofarabine is a next generation purine nucleoside antimetabolite. Nucleoside analogs are antimetabolites that affect DNA synthesis. ILEX obtained the right to develop clofarabine in the United States and Canada from Bioenvision Inc. (AMEX:BIV), which maintains its rights to develop clofarabine outside of those areas.

Source: ILEX Oncology Inc.

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