Committee recommends NeoPharm's phase 3 cintredekin besudotox trial continue as planned

By E. Janene Geiss

Philadelphia, Dec. 27 - NeoPharm, Inc. announced that the independent data monitoring committee responsible for overseeing the company's IL13-PE38QQR (cintredekin besudotox) pivotal phase 3 Precise trial for the treatment of glioblastoma multiforme, the most aggressive form of brain cancer, has recommended the trial continue as planned under the approved protocol.

As a result, enrollment is now formally closed, according to a company news release.

"We take the [committee's] recommendation as an affirmation of the high standards and care we took when designing the Precise trial study protocol," Guillermo A. Herrera, NeoPharm's president and chief executive officer, said in the release.

A total of 294 patients were enrolled in the trial with 276 patients with confirmed recurrent glioblastoma multiforme.

The enrolled patients will continue to be monitored as the trial progresses toward the interim efficacy analysis at 160 deaths and the final efficacy analysis at 215 deaths, if necessary.

These events are estimated to occur late in the second quarter of 2006, and late in the fourth quarter of 2006 or early 2007 respectively, officials said.

"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," Sandeep Kunwar of the University of California-San Francisco and principal investigator of the trial, said in the release.

As a result of the recommendation to continue the trial uninterrupted and unchanged, the company said it remains cautiously optimistic for a positive final outcome of the trial.

The company also said it anticipates starting a new phase 2 study of cintredekin besudotox for the treatment of malignant glioma at initial diagnosis.

A pediatric study also is planned for 2006, officials said.

Cintredekin besudotox has received orphan drug designation in Europe and the United States, and fast track drug development program status from the Food and Drug Administration. The development program also was selected to participate in the FDA Continuous Marketing Application Pilot 2 Program, officials said.

NeoPharm, based in Waukegan, Ill., is a biopharmaceutical company dedicated to research, development and commercialization of new cancer drugs for therapeutic applications.

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