-72%.
Surprised to see it did just 1 week better than gliadel.
Press Release Source: NEOPHARM, Inc.
NEOPHARM Announces Efficacy Results for Phase 3 PRECISE Trial
Monday December 11, 9:32 am ET
WAUKEGAN, Ill.--(BUSINESS WIRE)--NEOPHARM, Inc. (Nasdaq: NEOL - News) today announced that the pivotal Phase 3 PRECISE trial evaluating cintredekin besudotox (IL13-PE38QQR) for the treatment of recurrent glioblastoma multiforme (GBM) did not meet the efficacy endpoint at 215 deaths, which was a statistically significant difference, or separation, in the overall survival curves versus Gliadel Wafer®.
"Topline data suggests that cintredekin besudotox, while comparable, was not statistically superior to Gliadel," said Guillermo A. Herrera, President and Chief Executive Officer of NEOPHARM. "We will continue to work with our Scientific Advisory Board and the FDA to determine the best path forward."
Median Survival CB = 36.4 weeks
Median Survival Gliadel = 35.3 weeks
Months CB (% Survival) Gliadel (% Survival)
------ --------------- --------------------
6 69.4 62.4
12 35.1 30.1
18 20.0 14.5
24 14.4 14.5
The NEOPHARM Board of Directors and Senior Management have created a task force to evaluate Company options moving forward, including advancement of the Company's NeoLipid products.
"I want to extend my thanks to the patients and their loved ones, along with the investigators and personnel at study sites, and NEOPHARM employees for their effort in conducting this important trial," added Mr. Herrera. |
