NeoPharm cintredekin besudotox trial reaches second futility analysis, will likely continue

By Angela McDaniels

Seattle, Nov. 21 - NeoPharm said its cintredekin besudotox (IL13-PE38QQR) phase 3 trial for the treatment of Glioblastoma Multiforme, the most aggressive form of brain cancer, has reached the criterion for the second futility statistical analysis (100 deaths).

As a result, the trial's independent Data Monitoring Committee will review the second futility analysis and assess the study data to date at its clinical safety review meeting in December and provide its recommendation to the company thereafter.

"The timing for notification of meeting the trial criterion for the second futility analysis is beyond our original projections and may be evident of greater extended survival than originally assumed for patients receiving cintredekin besudotox compared to Gliadel Wafer in the study," NeoPharm president and chief executive officer Guillermo A. Herrera said in a company news release.

"Our confidence in the study continues and we remain cautiously optimistic regarding the potential for a favorable outcome. In the meantime, we continue to anticipate full enrollment in the trial by the end of this year."

Futility analyses are used by the committee to assess the current status of the study in terms of comparative treatment efficacy, the company said. Based on its review of this information, there are currently three potential recommendations that the committee can make to NeoPharm: continue the trial as-is with no interruption or changes; continue the trial as-is with no interruption, but add up to 25% (75) more patients to account for data variability; or stop the trial.

The company was notified in May by the committee that the study had reached the criterion for the first futility analysis (50 deaths). In June, the committee recommended that the study continue as planned.

Even in the event of a recommendation to increase the number of patients in the trial, the interim efficacy statistical analysis for the trial would continue to be triggered at 160 deaths, with final efficacy at 215 deaths, as per the company's amended Special Protocol Assessment, setting up the potential for a Biologic License Application filing as early as the second half of 2006, the company said.

Enrollment in the trial will continue uninterrupted until the committee makes its recommendation.

The phase 3 trials is designed to enroll up to 300 patients and compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with patients receiving Gliadel Wafer in the treatment of first recurrent Glioblastoma Multiforme following surgical tumor removal.

Patients are randomized so that up to 200 patients receive cintredekin besudotox and up to 100 patients receive Gliadel Wafer, the company said.

Cintredekin besudotox is a recombinant protein consisting of a single molecule composed of a tumor-targeting molecule (Interleukin-13) and a cytotoxic agent (Pseudomonas Exotoxin). The drug is delivered via Convection Enhanced Delivery, a drug delivery system using catheters placed following tumor removal in areas with microscopic tumor spread or at risk of tumor spread around the tumor resection cavity.

NeoPharm, based in Lake Forest, Ill., is a biopharmaceutical company that develops cancer drugs for therapeutic applications.

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