NeoPharm's recombinant protein increases life expectancy in patients with common malignant brain tumors

By Lisa Kerner

Erie, Pa., April 24 - NeoPharm, Inc. said that its recombinant protein, cintredekin besudotox (IL13-PE38QQR), continues to show evidence of prolonged overall survival in patients with recurrent glioblastoma multiforme (GBM), a common type of malignant primary brain tumor in adults.

GBM survival time ranges from six months to 12 months, even with surgery, radiation therapy and chemotherapy, according to a company news release.

Overall median survival for 45 GBM patients treated in the phase 1/2 intraparenchymal setting was 44 weeks, with survival increasing to 53.6 weeks for the 26 patients with two or more optimally placed catheters.

An independent statistical analysis of the phase 1/2 data confirmed that catheter placement was a key prognostic factor related to prolonged survival, the company said.

"These data are encouraging when you consider that median patient survival is approximately 28 weeks with currently available treatment options for recurrent GBM," said Sandeep Kunwar, lead investigator of the pivotal phase 3 Precise trial, in a company news release.

"The data further suggests that with improved drug delivery, via optimally placed catheters, we can further improve survival benefit."

In the phase 1/2 cintredekin besudotox program, patients underwent tumor resection followed by intraparenchymal infusion of cintredekin besudotox. Postoperative and follow-up MRI scans, performance status and survival were evaluated.

The most common treatment-related adverse events were headache, hemiparesis, sensory disturbance and aphasia/speech disorder.

Cintredekin besudotox has received orphan drug designation and fast track designation from the Food and Drug Administration, and has been accepted into the FDA's Pilot 2 Program for continuous marketing applications.

The company is presenting updated data for GBM patients treated in phase 1/2 studies and results from a phase 1/2 subset analysis at the 74th Annual Meeting of the American Association of Neurological Surgeons in San Francisco.

NeoPharm, based in Waukegan, Ill., is a biopharmaceutical company specializes in cancer drugs for therapeutic applications.

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