ARTICLE | Clinical News

Ceplene histamine dihydrochloride cancer data

August 1, 2011 7:00 AM UTC

A meta-analysis of data from 1,455 AML patients in first complete remission in 6 international trials showed that IL-2 alone did not significantly increase LFS or OS vs. standard of care (p=0.52 and p=0.46, respectively). Additionally, there was no statistical difference in IL-2 vs. controls in a subset analysis of age, sex, baseline performance, karyotype, AML subtype and time from achievement of first remission to initiation of maintenance therapy. Data were published in Blood.

EpiCept said the results support its position that including an IL-2 monotherapy arm in any subsequent clinical study would be unethical. In July, FDA requested the company to include an IL-2 monotherapy arm in a planned open-label Phase III trial as part of an SPA application (see BioCentury, July 4). EpiCept is seeking to meet with FDA to discuss the request and the SPA. ...