A Phase II clinical trial of ImmunoGen Inc.'s Oncolysin Simmunoconjugate for treating small cell lung cancer is underway, the company announced Wednesday.
The trial, which is being conducted at Massachusetts GeneralHospital by Thomas Lynch Jr., is one of several Phase II studiesthat ImmunoGen is planning for its drug. The trials aredesigned to "measure the effectiveness of Oncolysin S inprolonging patients' disease-free survival," explained CarolEpstein, vice president and chief medical officer of theCambridge, Mass., company.
"We also will test whether treatment with Oncolysin S canbenefit patients by turning partial remissions induced withconventional therapy into complete remissions," he said.
Small cell lung cancer (SCLC) is an insidious and deadly diseasethat strikes more than 48,000 people in the U.S. yearly. Manypatients suffering from the disease can be put into an initialremission by conventional chemotherapy, but they almostalways relapse in a matter of months. Less than 5 percent ofSCLC patients survive long-term.
ImmunoGen's (NASDAQ:IMGN) antibody-toxin conjugate bindsspecifically to an antigenic marker (CD56) found on the surfaceof SCLC cells. The antibody, conjugated to a derivative of thepowerful plant toxin ricin, is intended to seek metastasizedSCLC cells and destroy them.
The immunoconjugate proved safe and well-tolerated in PhaseI trials on 21 patients who had relapsed from SCLC.Importantly, the trial, which was conducted by Lynch at theDana Farber Cancer Institute in Boston, also demonstrated thatthe drug is delivered to the tumor.
"We also saw evidence of efficacy in more than 30 percent ofthe patients treated in the Phase I trial," ImmunoGen's Epsteinsaid.
The Phase II trials will study the drug's efficacy in patientswho are in remission following conventional chemotherapy, butwho have not relapsed. The trials will determine the best wayto use the drug in combination with conventionalchemotherapy, as well as by itself after chemotherapy, saidMark Ratner, ImmunoGen's director of externalcommunications.
Overall, the company intends to enroll between 50 and 60patients in the Phase II trials, he added.
-- Jennifer Van Brunt Senior Editor
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