STUDIESImmunoGen Inc.'s clinical investigators said results ofPhase I/II tests involving Oncolysin B in combinationwith chemotherapy showed the drug was well tolerated atall dosage levels in patients suffering from AIDS-relatedlymphoma.
Twenty-six patients were selected to participate in thedose-escalation trial after responding to two of six cyclesof conventional chemotherapy treatments. All the patientsreceived a seven-day infusion of Oncolysin B with theirthird cycle of chemotherapy and half of the patientsreceived a second seven-day infusion during their fourthcycle of chemotherapy.
Mark Ratner, director of external communications for theCambridge, Mass.-based company, said the data showedOncolysin B was safe at the highest dosage levels.
In addition, the current median survival of the 26 patientswho received Oncolysin B is 19 months. Median survivalof patients with AIDS-related lymphoma typically is sixto seven months with conventional chemotherapy.
Data from the Phase I/II study were reported at the 36thannual meeting of the American Society of Hematologyin Nashville.
Ratner said ImmunoGen initiated a second clinical studyin September with 20 patients who will receive 28-dayinfusions of Oncolysin B. The trial is expected to becomplete by the middle of next year.
Oncolysin B is comprised of the anti-B4 monoclonalantibody and the modified plant toxin "blocked ricin."The immunotoxin is directed to CD19+ cells and deliversthe toxic portion of blocked ricin to the cytoplasm, whereit inhibits protein synthesis.
In addition to studying Oncolysin B for treatment ofAIDS-related lymphoma, ImmunoGen has other trials ofthe drug underway: a Phase III for preventing relapses oflymphoma after autologous bone marrow transplants; aPhase II study for preventing relapses of lymphoma andleukemia after chemotherapy; and Phase I/II trials forpediatric lymphoma and leukemia.
A Phase I/II study of Oncolysin B for purging bonemarrow during transplants for lymphoma is completed,but results have not been released. _ Charles Craig
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