Lilly Launches Phase III Trial of Once-Daily, Targeted Oral Cancer Agent
31 May 2006 - 10:00PM
PR Newswire (US)
Late-stage trial in non-Hodgkin's lymphoma currently enrolling
patients INDIANAPOLIS, May 31 /PRNewswire-FirstCall/ -- For the
second time in as many months, Eli Lilly and Company has announced
the initiation of a Phase III clinical trial studying enzastaurin,
an investigational, multi-targeted, oral, cancer agent. This trial
will investigate enzastaurin's potential in treating patients with
non-Hodgkin's lymphoma (NHL), the most common cancer of the
lymphatic system, which acts to defend the body against disease.
Specifically, enzastaurin will be evaluated as a maintenance
therapy in patients with diffuse large B-cell lymphoma who have
achieved remission following first-line therapy. Diffuse large
B-cell lymphoma (DLBCL) is the most common form of NHL and the goal
of maintenance therapy is to prevent relapse. In March, Lilly
announced the first Phase III trial for enzastaurin in
glioblastoma, a common type of brain cancer. Phase II trial results
for enzastaurin in glioblastoma and non-Hodgkin's lymphoma were
presented at last year's American Society of Clinical Oncology and
American Society of Hematology annual meetings, respectively. "The
incidence of non-Hodgkin's lymphoma has been increasing rapidly
over the past 25 years," said Richard Gaynor, M.D., vice president,
cancer research and global oncology platform leader for Eli Lilly
and Company. "In recent years, there has been much progress in
developing therapies that get more patients into remission.
However, our objective with enzastaurin is to develop an agent with
the ability to keep NHL patients in remission. Early clinical
studies of enzastaurin in NHL have been promising and we are
excited about continuing our investigation in this trial." The
enzastaurin non-Hodgkin's lymphoma Phase III trial (PRELUDE -
Preventing Relapse in Lymphoma Using Daily Enzastaurin) is a
randomized, placebo controlled study of patients in their first
remission from DLBCL. The study will compare the efficacy, safety
and tolerability of enzastaurin, taken orally for up to three
years, versus placebo. A steering committee will oversee this
study, which is planned to enroll 459 patients across 100 sites
worldwide. The primary endpoint of this study will be overall
disease-free survival. Additionally, Lilly will be assessing any
biomarkers relevant to enzastaurin as a basis for correlating
patient response to clinical trial outcomes. Following the
appropriate administrative steps, more details on the study design
and information on global recruitment sites will be available 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 a distinct mechanism of action. Preclinical
data suggest it may attack the tumor in three ways: by reducing the
cell's ability to divide (cell proliferation), increasing the
natural death of the tumor cells (apoptosis), and inhibiting
tumor-induced blood supply (angiogenesis). Data have suggested
enzastaurin inhibits signaling through the PKC-beta and PI3K/AKT
pathways. These pathways have been shown to be activated in a wide
variety of cancers. In addition to non-Hodgkin's lymphoma,
enzastaurin is also being studied in other tumor types, including
glioblastoma, colorectal cancer, non-small cell lung cancer,
pancreatic cancer, and mantle cell lymphoma. Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma is the most common cancer of the lymphatic
system, the body's defense mechanism against infection and disease.
Once considered rare, non-Hodgkin's lymphoma rates have increased
83 percent in the past 25 years. NHL is now considered the fifth
most common of all cancers, with more than 56,000 new diagnoses
made in the United States each year and 46,000 new cases each year
in the European Union. About Lilly Oncology, a division of Eli
Lilly and Company For more than four decades, Lilly Oncology has
been collaborating with cancer researchers to deliver innovative
treatment choices and valuable programs to patients and physicians
worldwide. Inspired by the courageous patients living with cancer,
Lilly Oncology is providing treatments that are considered global
standards of care and developing a broad portfolio of novel
targeted therapies to accelerate the pace and progress of cancer
care. To learn more about Lilly's commitment to cancer, please
visit http://www.lillyoncology.com/. 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. 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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Christine Van Marter of Eli Lilly
and Company, +1-317-651-1473, cell: +1-317-554-7923,
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