The preliminary Phase I/II clinical trial data of Genetics InstituteInc.'s recombinant human interleukin-11 (rhIL-11) for treatingbreast cancer patients undergoing chemotherapy indicated that theblood cell growth factor is able to increase platelet production at alldoses tested.

The data on the first 12 patients enrolled in this trial were presentedtoday by the study's principal investigator, Michael Gordon ofIndiana University, at a Serono Symposium on "Platelets and CellularSupport in Clinical Oncology" in Arlington, Va.

Gordon and his colleagues found that rhIL-11 (or Neumega) was ableto increase the production of blood platelets in all 12 patients at alldoses tested. Chemotherapy usually results in moderate to severethrombocytopenia (low platelet counts). The researchers also notedthat Neumega, at intermediate doses of 25 to 50 micrograms perkilogram body weight per day, continued to increase platelet levelsand was well-tolerated by patients even through multiple cycles ofchemotherapy treatment.

The trial, which GI (NASDAQ:GENIZ) of Cambridge, Mass., initiated inlate 1992, tested doses of Neumega ranging from 10 to 100micrograms per kilogram body weight per day in a total of 16patients, explained GI spokesman Dennis Harp. The results reportedby Gordon concern the first 12 patients enrolled in the study, testedat doses up to 75 micrograms. "By the time of the American Societyof Hematology meeting in December we should have data on theother patients," he told BioWorld.

GI is already conducting a second Phase I/II clinical trial ofNeumega, this one in breast cancer patients who are scheduled toreceive bone marrow transplants in support of their cancertreatment. That trial began several months ago, Harp told BioWorld.

"We look forward to completing this second study in the next severalmonths and to starting our first multicenter Phase II trial ofNeumega rhIL-11 before the end of this year," added Patrick Gage,GI's executive vice president.

Schering-Plough Corp. is GI's partner for marketing Neumega inEurope, Latin America and Africa. In Japan, GI has licensed therecombinant blood factor to GI-Yamanouchi Inc., its joint venturewith Yamanouchi Pharmaceutical Co., for development andmarketing.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.