Genta Inc. on Tuesday said it has filed its first investigationalnew drug application with the Food and Drug Administration,for Phase I/II clinical trials of its antisense compound totreat chronic myelogenous leukemia (CML).
Genta's filing will make it the first antisense compound toenter the clinic, said Thomas H. Adams, chairman and chiefexecutive officer of the San Diego company. "This is a realmilestone for Genta and for antisense in general," he said.
CML is a life-threatening cancer in which white blood cellsgrow uncontrollably. It is caused by a translocation of aportion of chromosomes 9 and 22. Genta's antisenseoligonucleotide binds to a specific piece of messenger RNA toblock translation of the protein that causes the white bloodcells to proliferate.
Genta's trial will begin within three to six months at theUniversity of Texas M.D. Anderson Cancer Center in Houston.Patients' bone marrow samples will be treated with thecompound to kill abnormal cells. Patients will undergo totalbody radiation, and the treated marrow will be transplantedback into the patients.
Adams estimated the U.S. market for the compound at $60million annually. He expects market approval in three to fiveyears.
Other companies targeting myelogenous leukemias includeImmunoGen Inc. and Synergen Inc. Synergen began Phase IItrials of its Antril interleukin-1 receptor antagonist to treatCML in June. Schering-Plough's Intron A alpha interferon hasFDA approval for treating CML.
ImmunoGen's Oncolysin-M uses an antibody linked to blockedricin toxin to target both CML and acute myelogenous leukemia.The company is conducting Phase I trials of an in vivo therapyand an ex vivo therapy involving bone marrow purging.
There are about 12,000 cases of myelogenous leukemia in theUnited States every year, according to ImmunoGen spokesmanMark Ratner.
-- Karen Bernstein BioWorld Staff
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