Enzastaurin Granted Orphan Drug Status For Treatment Of Diffuse Large B-Cell Lymphoma

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BlankEnzastaurin Granted Orphan Drug Status For Treatment Of Diffuse Large

B-Cell Lymphoma (DLBCL)

Article Date: 02 Apr 2007 - 0:00 PDT

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.

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