Eli Lilly and Company announced 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 per cent 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. An International Prognostic Index score (IPI) is a criteria determined by a patient's oncologist.

Enrolment into a phase III clinical trial studying enzastaurin is currently underway. The PRELUDE (Preventing Relapse in Lymphoma Using Daily Enzastaurin) trial is a randomised, 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 enrol 459 patients across 100 sites worldwide. The primary endpoint of the study will be overall disease-free survival.

"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, vice president, cancer research and global oncology platform leader for Eli Lilly and Company.

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 tumour cell proliferation, induces tumour cell death and inhibits induced-induced angiogenesis. Treatment has been well tolerated with minimal drug-related toxicity. Enzastaurin administration is associated with fatigue, diarrhoea, nausea, decreased platelets, cough, vomiting, transaminase elevation, dyspnea, peripheral edema, and dizziness.