Dacogen® (Decitabine) for Injection Phase III
AML Results Announced
sNDA Submission to FDA by Eisai Planned Based on Preliminary Results
June 30, 2010 08:18 AM Eastern Daylight Time
DUBLIN, Calif.--(EON: Enhanced Online News)--SuperGen, Inc. (Nasdaq: SUPG), a pharmaceutical company
dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released
information regarding a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection in elderly patients
with acute myeloid leukemia (AML). The comparator in this trial was low-dose cytarabine, a chemotherapy agent,
or supportive care.
Overall survival was the primary endpoint of this study. While Dacogen did not achieve statistically significant
superiority over the control arm, a trend was evident.
Based on the primary analysis and supporting data from secondary endpoints in this Phase III trial, SuperGen’s
partner, Eisai, has announced its plan to submit to the U.S. Food and Drug Administration (FDA) a supplemental
New Drug Application (sNDA) for Dacogen in the treatment of elderly patients with AML and poor- or
intermediate-risk cytogenetics. Eisai has stated that the sNDA will be submitted to FDA by March 31, 2011.
Eisai and Cilag GmbH International are further examining the data to better understand the full implications of the
study. Eisai will present to the medical community at future major meetings and in peer-reviewed publications the
comprehensive data sets from the Phase III trial.
“SuperGen is encouraged by Eisai’s intent to file an sNDA for Dacogen in a new indication,” said James S.J.
Manuso, Ph.D., President and Chief Executive Officer. “Analysis of the study results is ongoing, and Eisai will submit
the results for presentation at major medical meetings and peer-reviewed publications.”
The most frequently reported adverse events observed during the Phase III trial include neutropenia, anemia,
thrombocytopenia, fever and pneumonia. Sepsis and febrile neutrope