Enzastaurin Granted Orphan Drug Status for Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)
March 26 2007 - 8:54AM
PR Newswire (US)
Oral Agent Designed to Address High Incidence of Relapse in DLBCL
Population INDIANAPOLIS, March 26 /PRNewswire-FirstCall/ -- Eli
Lilly and Company announced today that the European Medicines
Agency (EMEA) has granted enzastaurin, an investigational,
multi-targeted, oral, cancer agent, orphan drug designation for the
treatment of diffuse large B-cell lymphoma (DLBCL). Although rare,
DLBCL is the most common sub-type of non-Hodgkin's lymphoma (NHL)
of which approximately 50% of high-risk patients (high-risk is
defined as having an International Prognostic Index score of 3-5)
relapse within three years after receiving first line therapy. (1)
An International Prognostic Index score (IPI) is a criteria
determined by a patient's oncologist. Enrollment into a Phase III
clinical trial studying enzastaurin is currently underway. The
PRELUDE (Preventing Relapse in Lymphoma Using Daily Enzastaurin)
trial is a randomized, placebo controlled study in DLBCL patients
at high risk for relapse who have achieved remission following
first-line therapy. Specifically, enzastaurin is being investigated
as a maintenance therapy to prevent disease relapse. The study will
compare the efficacy, safety and tolerability of enzastaurin, taken
orally for up to three years, versus placebo. The study is expected
to enroll 459 patients across 100 sites worldwide. The primary
endpoint of the study will be overall disease-free survival. More
details on the study design, inclusion criteria and how to enroll
are available at http://www.lillytrials.com/ or by visiting
http://www.clinicaltrials.gov/. "In recent years, there has been
progress in improving first-line therapies that help more patients
achieve remission. However, our objective with enzastaurin is to
develop an agent that may fill this important therapeutic need --
the ability to keep DLBCL patients in remission," said Richard
Gaynor, M.D., vice president, cancer research and global oncology
platform leader for Eli Lilly and Company. Enzastaurin Enzastaurin
is an oral, serine threonine kinase inhibitor which selectively
targets the PKCBeta and PI3/AKTsignaling pathways. By blocking
these key pathways frequently over-expressed in a wide variety of
cancers, enzastaurin suppresses tumor cell proliferation, induces
tumor cell death and inhibits tumor-induced angiogenesis. Treatment
has been well tolerated with minimal drug-related toxicity.
Enzastaurin administration is associated with fatigue, diarrhea,
nausea, decreased platelets, cough, vomiting, transaminase
elevation, dyspnea, peripheral edema, and dizziness. Further
testing in Phase III versus a placebo will provide us with a more
complete look at the side effect profile for enzastaurin. In
addition to DLBCL, enzastaurin is also being studied in other tumor
types including breast, colon, lung, ovarian and prostate cancers.
Non-Hodgkin's Lymphoma and Diffuse Large B-cell 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. Diffuse large B-cell lymphoma (DLBCL)
describes the appearance of the malignant B-cells in the lymphoma
and it is the most frequently occurring histologic subtype in
adults, constituting approximately 31% of all new diagnoses
(Armitage and Weisenburger 1998). The vast majority of relapses
occur in the first 2 years after therapy (Cabanillas et al. 1992).
Life expectancy of untreated patients with DLBCL is very short.
Orphan Medical Product Designation in the European Union Orphan
medicinal products are for diagnosing, preventing or treating life-
threatening or very serious conditions that are rare and affect not
more than 5 in 10,000 persons 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. 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 filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (1) Shen, Laurie H and col.
2007. The Revised International Prognostic Index (R-IPI) is a
better predictor of outcome than the standard IP for patients with
diffuse large B cell Lymphoma treated with RCHOP. Blood 109
(N5):1857, 1861. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO)
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://photoarchive.ap.org/ DATASOURCE: Eli Lilly and Company
CONTACT: Christine Van Marter of Eli Lilly and Company,
+1-317-651-1473, or
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