ImClone Systems Inc. filed an investigational new drug applicationwith the FDA for interleukin-6 mutein (IL-6m), with an intendedindication of treating the decrease in circulating blood platelets(thrombocytopenia) associated with chemotherapy.The mutein is a non-glycosylated variant of native IL-6, and alsocontains a 22-amino acid deletion, making the molecule more activeand easy to produce in bacterial systems. The company said animalstreated with IL-6m showed three-fold increases in platelet production,with an acceptable side-effect profile at all dose levels.In March, Hadassah Hospital in Jerusalem started human studies of theImClone's IL-6m in advanced lung and ovarian cancer patients.Patients receive IL-6m at various doses before and after cycles ofchemotherapy.In the U.S., the study will involve patients with breast and lung cancer,and IL-6m will be given only after patients receive chemotherapy,Andrea Rabney, director of investor relations for the New Yorkcompany, told BioWorld.Last summer ImClone regained worldwide rights to IL-6m fromErbamont N.V. of Italy, ending a four-year collaboration. In Februarythe company received a notice of allowance for its patent applicationon recombinant protein, which the company said is the first allowancecovering any form of IL-6. _ Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.