Lilly Launches Phase III Trial of Targeted Cancer Agent

Enzastaurin Study Enrolling Patients with Glioblastoma 


INDIANAPOLIS, March 9  /PRNewswire-FirstCall/ -- One of the deadliest and rarest forms of cancer is the focus of a Phase III study initiated by Eli Lilly and Company today.  Enzastaurin, an investigational, targeted, oral agent, will be evaluated at more than 100 sites worldwide for the treatment of relapsed glioblastoma multiforme (GBM), an aggressive and malignant form of brain cancer.

"Glioblastoma is a devastating disease for patients often slowly impacting their cognitive thinking and emotional responses," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Eli Lilly and Company.  "Through its distinct mechanism of action, preclinical studies suggest that enzastaurin attacks the tumor in multiple ways.  While there have been some recent advances in treating this devastating disease, survival rates are still low.  Enzastaurin is a promising agent, and we look forward to further investigating its ability to treat this disease."

The enzastaurin glioblastoma Phase III trial (STEERING - Study Evaluating Enzastaurin in Recurrent Glioblastoma) is a randomized, open label registration study in recurrent GBM, which will compare the efficacy, safety and tolerability of enzastaurin, taken orally, versus CeeNU(R) (lomustine[CCNU]), a common oral chemotherapy used to treat this disease.  Dr. Howard Fine, chief of Neuro-Oncology at the National Cancer Institute, will be the principal investigator for this study that will enroll 397 patients.  The primary endpoints of this study will be progression-free survival and overall survival.  In this study, Lilly will analyze tissue samples to identify potential biomarkers as a basis for correlating patient response to clinical trial outcomes.  More details on the study design and information on global recruitment sites may be found at http://www.clinicaltrials.gov/ , http://www.lillytrials.com/ or by calling 1-877-CTLilly (1-877-285-4559).

Enzastaurin is an oral serine-threonine kinase inhibitor that is designed to suppress tumor growth through multiple mechanisms.  Preclinical data indicate it may reduce the cell's ability to reproduce (cell proliferation), increase the natural death of the tumor cells (apoptosis), and inhibit tumor- induced blood supply (angiogenesis).  Enzastaurin has been shown to inhibit signaling through the PKC-B and PI3K/AKT pathways.  These pathways have been shown to be activated in a wide variety of cancers.  In addition to glioblastoma, enzastaurin is also being studied in multiple other tumor types, including non-Hodgkin's lymphoma, colorectal cancer, non-small cell lung cancer, pancreatic cancer, and mantle cell lymphoma.

Orphan Drug Status

Enzastaurin has been granted orphan drug designation by the European Agency for the Evaluation of Medicinal Products (EMEA) and by the United States Food and Drug Administration's Office for Orphan Products Development for the treatment of glioblastoma.

Glioblastoma

Glioblastoma is the most aggressive and malignant form of glioma, a type of primary brain cancer.  In the early stages, glioblastoma tumors often grow quickly and without symptoms, becoming quite large before signs of altered brain function arise.  Surgery is generally the first line of treatment, followed by radiation and/or chemotherapy.  Although primary treatment is often successful in temporarily stopping the progression of the tumor, glioblastomas almost always recur and survival rates remain low.

About Lilly Oncology, a Division of Eli Lilly and Company

The mission of Lilly Oncology is to deliver innovative treatment strategies and essential support programs to physicians and their patients for their battle against cancer.  From chemotherapies that have become standards of care to novel targeted therapies currently being investigated, Lilly has been at the forefront of cancer research for more than 40 years.  Lilly Oncology continues in its spirit of innovation with a robust and dynamic pipeline, developing treatments for rare and difficult-to-treat tumors where unmet needs are greatest.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.  Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

National Cancer Institute

For more information you can visit the institute's website at http://home.ccr.cancer.gov/nob or by calling toll free at 1-866-251-9686. P-LLY

This press release contains forward-looking statements about the potential of the investigational compound enzastaurin (LY317615) and reflects Lilly's current beliefs.  However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review.  There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company.  There is also no guarantee that the product will prove to be commercially successful.  For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission.  Lilly undertakes no duty to update forward-looking statements.

  Alimta(R) (pemetrexed, Eli Lilly and Company)
  Gemzar(R) (gemcitabine HCl, Eli Lilly and Company)
  CeeNU(R) (lomustine [CCNU], Bristol Myers Squibb)

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DATASOURCE: Eli Lilly and Company



CONTACT:  Christine Van Marter of Eli Lilly and Company, [phone],

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