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news.Keryx Biopharmaceuticals has reported early positive results of a Phase II single agent trial of perifosine in patients with malignant anaplastic gliomas, a form of brain tumor.
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In the study, 25 patients with advanced malignant gliomas were treated with a loading dose of 600mg (150mg x 4) followed by 100mg daily dose of perifosine. Patients must have failed prior radiation therapy and have shown unequivocal evidence for tumor progression by MRI or CT scan. There was no limitation on the number of prior relapses or prior therapies and patients with a KPS greater than or equal to 50 were eligible.
The median progression free survival (PFS) and overall survival in the anaplastic glioma (AA) group was nine weeks (range 2 weeks to 50 weeks) and 49 weeks, respectively. Toxicity was minimal with the following reported events: grade 1 nausea, grade 1 diarrhea, grade 2 pain and grade 4 gout exacerbation.
The study was designed to enroll at least 12 evaluable malignant glioblastoma (GBM) patients and at least 10 evaluable AA patients. If at least one patient achieves six-month PFS, the study would continue to enroll an additional subset of patients. Therefore, the GBM arm has been halted and the AA arm will continue to enroll. The company said that final study updates will be reported later.