NeoPharm: phase 3 trial in brain cancer treatment reaches criteria for interim analysis

By Lisa Kerner

Charlotte, N.C., June 8 - NeoPharm said its pivotal phase 3 Precise trial of cintredekin besudotox (IL13-PE38QQR) for the treatment of glioblastoma multiforme (GBM), the most aggressive form of brain cancer, has reached the criterion for the interim efficacy statistical analysis (160 deaths).

The trial's independent Data Monitoring Committee can now assess the study data, conduct an interim efficacy analysis and provide recommendations.

NeoPharm said it expects to receive the committee's recommendations within two weeks.

The final efficacy analysis will be completed following the 215th death, expected to occur in late 2006 or early 2007, according to a company news release.

The recombinant protein cintredekin besudotox consists of a single two-part molecule: a tumor-targeting molecule (Interleukin-13, or IL13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE) and is delivered to the tumor area using catheters.

The Precise trial was designed to enroll up to 300 patients to obtain 270 patients with confirmed GBM. Patients were randomized 2:1 to compare overall patient survival curves of the two treatment groups.

NeoPharm is a biopharmaceutical company based in Waukegan, Ill.

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