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 clinicaltrials, lillytrials
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
home.ccr.cancer/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)
Eli Lilly and Company
lillytrials