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Thema: Presse: Enzastaurin for brain tumor treatment

Presse: Enzastaurin for brain tumor treatment
Katja[a]
19.03.2006 19:30:42
Eli Lilly Launches Phase III Study Of
Enzastaurin For Brain Tumor Treatment

Early Thursday, Indianapolis, Indiana-based pharmaceutical company Eli Lilly and Company (LLY | charts | news | Powerrating) announced the launch of Phase III study of Enzastaurin for the treatment of relapsed glioblastoma multiforme or GBM, an aggressive and malignant form of brain cancer.

Although primary treatment for glioblastoma is often successful, glioblastomas almost always recur and survival rates remain low. Enzastaurin, an investigational, targeted, oral agent, is designed to suppress tumor growth through multiple mechanisms. Preclinical studies of Enzastaurin indicated that it may reduce the cell´s ability to reproduce, increase the natural death of the tumor cells and restrain tumor- induced blood supply.

The randomized, open label registration study named STEERING will compare the efficacy, safety and tolerability of enzastaurin, taken orally, against CeeNU , a common oral chemotherapy used to treat this disease. The primary endpoints of this study will be progression-free survival and overall survival.

The trial will also analyze tissue samples to identify potential biomarkers as a basis for correlating patient response to clinical trial outcomes. The drug will be evaluated at more than 100 sites worldwide, with 397 enrolled patients, and Dr. Howard Fine, chief of Neuro-Oncology at the National Cancer Institute, will be the principal investigator for the study.

In addition to glioblastoma, enzastaurin has been studied in multiple other tumor types, including non-Hodgkin´s lymphoma, colorectal cancer, non-small cell lung cancer, pancreatic cancer, and mantle cell lymphoma. European Agency for the Evaluation of Medicinal Products or EMEA and United States Food and Drug Administration´s Office for Orphan Products Development have granted orphan drug designation to this drug for the treatment of glioblastoma.

LLY closed Wednesday´s regular trading session up $0.75, at $57.36, on a volume of 4.25 million shares.

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Thursday, March 09, 2006
Katja[a]
NACH OBEN