Ilex Oncology Inc has initiated two Phase II clinical trials to evaluate the investigational anticancer agent clofarabine in children with acute lymphocytic leukemia (ALL) and acute myelogenous leukemia (AML). These trials are highly unusual in that Ilex and leading pediatric researchers are studying this new anticancer compound in children at the same time that other researchers are studying the same investigational agent in adult AML. These studies will be part of the clofarabine co-development conducted by Ilex and its partner Bioenvision Inc.

"For decades children with cancer have been viewed as therapeutic orphans because they have not been able to take advantage of the newest medical developments," said Steve Weitman, pediatric oncologist and Vice President, Global Cancer Research, Ilex Oncology. "These two clofarabine trials are unique in that Ilex is committed to moving children to the front of the line, giving them access to this promising new compound at the earliest time possible. This is especially important for the 30 to 60 percent of children with leukemias who fail current therapies and have limited treatment options."

Almost exclusively, new cancer treatments have been historically studied and approved for adults long before they are investigated and approved for use in children. Despite the fact that more than 12,000 children are diagnosed with cancer annually, only one of the 50 new oncology agents approved by the U.S. Food and Drug Administration (FDA) in the past 20 years has a pediatric indication and this drug received approval more than eight years ago.

Each of the two open-label Phase II studies will evaluate the overall response rates of clofarabine in 40 children with refractory or relapsed ALL or AML. Eligible patients for the AML study must be in first or subsequent relapse, while patients with ALL must be in second or subsequent relapse. Clofarabine will be administered by intravenous infusion over 2 hours daily for five consecutive days and repeated every 2 to 6 weeks as indicated by leukemia recurrence or recovery of normal hematopoiesis.