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NeoPharm Pleased with PRECISE Trial Results
Posted on 2005-12-27 11:36:00
NeoPharm, Inc. today announced that the independent Data Monitoring Committee, responsible for overseeing the company's IL13-PE38QQR (cintredekin besudotox) Pivotal Phase III PRECISE trial for the treatment of Glioblastoma Multiforme (GBM), the most aggressive form of brain cancer, has met, analyzed, and reviewed the data for the trial's second futility analysis, and has recommended that the PRECISE Trial continue as planned under the approved protocol. As a result, enrollment in the PRECISE Trial is now formally closed.
"We are pleased with the DMC's recommendation on the PRECISE Trial," said Guillermo A. Herrera, NeoPharm's president and chief executive officer. "We take the DMC's recommendation as an affirmation of the high standards and care we took when designing the PRECISE Trial study protocol. I appreciate and want to publicly recognize the hard work and dedication that our Employees and Investigators showed during the design and enrollment stages of the Trial."
A total of 294 patients were enrolled in the PRECISE Trial, with 276 patients with confirmed recurrent GBM. The enrolled patients will continue to be monitored as the Trial progresses towards the interim efficacy analysis at 160 deaths and the final efficacy analysis at 215 deaths, if necessary. These events are currently estimated to occur late in the second quarter of 2006, and late in the fourth quarter of 2006 or early 2007, respectively.
"I am pleased with the recommendation of the independent Data Monitoring Committee," stated Sandeep Kunwar, MD, of the University of California-San Francisco, and Principal Investigator of the Company's PRECISE trial. "PRECISE is a very important study of a promising and unique therapeutic advance for the treatment of a terrible disease. The investigator and patient interest in this study is very gratifying."
As a result of the DMC's recommendation to continue the trial uninterrupted and unchanged, the Company remains cautiously optimistic for a positive final outcome of the PRECISE Trial. In addition, in 2006 the Company currently anticipates commencing a new Phase II study of cintredekin besudotox for the treatment of malignant glioma at initial diagnosis. A pediatric study is also planned for 2006.
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