SUNDAY NOV 18, 2007 (Foodconsumer.org) -- Genentech, Inc. announced today that a better than expected percentage of patients with   relapsed glioblastoma multiforme (GBM) the most common and aggressive brain cancer remained free of progression for six months when they used Avastin (or bevascizumab) alone or in combination with irinotecan chemotherapy.

The randomized, multi-center Phase II clinical trial reported at the 12th Annual Scientific Meeting of the Society for Neuro-Oncology showed "36 percent (31/85) of GBM patients treated with Avastin alone, and 51 percent (42/82) of patients treated with Avastin in combination with chemotherapy, lived without the disease advancing within six months," Genentech said in its press release.

"Historical estimates suggest that only 15 percent of patients with this aggressive type of brain cancer live without their cancer progressing within six months," said Timothy Cloughesy, M.D., director, Neuro-Oncology Program of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles and lead investigator for the study.

"The findings suggested that at six months, more patients had lived without their cancer advancing when Avastin was administered as a single-agent or in combination with chemotherapy, than what we would normally expect."

"These findings exceeded our expectations, and due to the high unmet medical need of patients with relapsed GBM we plan to discuss these data with the FDA to determine next steps," said

Based on the results and the high medical need of patients with the brain cancer, the company plans to discuss these data with the FDA to determine next steps, said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer.

In the United State an estimated 20,500 new cases of brain cancer are diagnosed each year and 12,740 patients will die from the disease, according to the American Cancer Society.   The five-year survival rate for patients with GBW is only 3 %.

The trial involved 167 patients with BGM whose cancer had relapsed after first or second-line therapy.   They had received temozolimide earlier. During the up-to 104 weeks of trial, patients were given Avastin alone or in combination with irinotecan every other week.

The data presented so far covered only the first six months.   Overall survival rate and the drug safety for a longer period are expected in 2008.

Avastin is designed to inhibit vascular endothelial growth factor which plays an important role in angiogenesis and the maintenance of existing blood vessels through the lifecycle of a tumor, according to the company. This effect is expected to reduce the tumor's ability to grow and spread in the body.

Avastin was first approved on Feb. 26, 2004 as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.   The drug was also approved on Oct. 11, 2006 as the first line treatment of patients with unresectable, locally advanced, recurrent or metatatic nonn-squamous, non-small cell lung cancer.

"The most serious adverse events associated with Avastin across all trials were GI perforation, wound healing complications, hemorrhage, non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome (RPLS), neutropenia and infection, nephrotic syndrome and congestive heart failure," the company said in its announcement.