Genetics Institute Inc. said Phase II studies of its recombinant humaninterleukin-11 (IL-11) drug demonstrated statistical significance inrestoring platelets in cancer chemotherapy patients to levels highenough that they could avoid blood transfusions.
Data from more than 80 patients at 20 medical centers involved in thetrials showed that 23.6 percent of those who received daily doses ofIL-11 did not need transfusions to restore platelets, which typicallyare reduced by chemotherapy treatments.
Low platelet levels can trigger uncontrolled bleeding and in treatingcancer patients, chemotherapy doses are reduced to preventdangerous reductions in platelets. But when platelet levels sink toolow, transfusions are required, generating risk of infection.
Genetics Institute's stock (NASDAQ:GENIZ) jumped $3.12Thursday to close at $37.12, a 9 percent increase.
The cancer patients involved in Genetics Institutes' double-blind,placebo-controlled trials were divided into three groups. One-third ofthe participants received a 50 microgram per kilogram dose of IL-11,one-third received a 25 microgram per kilogram dose and one-thirdreceived a placebo.
All but 4 percent required a transfusion in the placebo group whiletransfusions were not needed for 30 percent in the higher dose groupand for 18 percent in the lower dose group. The data alsodemonstrated that those treated with IL-11 required fewertransfusions than those in the placebo group.
Paul Schendel, Genetics Institute's senior scientist and director of theIL-11 project, said Phase III studies will begin by the end of the year,but details of the trials still are being devised.
Schendel said IL-11 is a hematopoietic growth factor that affects notonly the megakaryocytes that lead to the development of platelets, butalso stimulates earlier stage cells involved in other blood celllineages.
The advantage to reaching cells further back in the blooddevelopment process, Schendel said, is that even if allmegakaryocytes are killed by the chemotherapy, the IL-11 still maybe able to generate platelets. n
-- Charles Craig
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