Lilly Launches Phase III Trial of Targeted Cancer Agent

Indianapolis (ots/PRNewswire) -

- Enzastaurin Study Enrolling Patients with Glioblastoma

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 www.clinicaltrials.gov ,
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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ots Originaltext: Eli Lilly and Company
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Contact:
Christine Van Marter of Eli Lilly and Company, +1-317-651-1473,
pager: +1-888-448-9126, Email: vanmarterch@lilly.com Photo: NewsCom:
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