FRAZER, Pa., June 19 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced results from a pivotal clinical trial of lestaurtinib (CEP-701) in patients with relapsed acute myelogenous leukemia (AML) expressing FLT3 activating mutations. The study was designed to show the benefit of lestaurtinib in this patient population when given in sequence with standard induction chemotherapy compared to those treated with standard induction chemotherapy alone. An analysis of the study showed that patients who were treated with lestaurtinib showed similar rates of complete response but no increased benefit in overall survival, compared to those who received induction chemotherapy alone.
'We are disappointed that this study with lestaurtinib did not demonstrate a benefit for this patient population but we remain committed to oncology clinical research and developing innovative therapies for life-threatening diseases,' said Dr. Lesley Russell, Executive Vice President and Chief Medical Officer at Cephalon.
The results of this study in relapsed AML will be submitted for presentation at a future medical meeting. The outcome of this study has no impact on the company's previously issued financial guidance for 2009.
'We made a significant financial investment in this pioneering effort to develop lestaurtinib for this molecularly targeted patient population with a poor prognosis and few treatment options,' said Frank Baldino, Jr., Ph.D., Cephalon founder, chairman and CEO. 'Patients with life-threatening diseases need companies like Cephalon to make that investment and take that risk if we are to improve patient outcomes and the overall cost of healthcare.'
Developed by Cephalon scientists, lestaurtinib is a potent inhibitor of several tyrosine kinases including FLT3 and a Janus kinase (JAK2). In leukemic cells, lestaurtinib inhibits FLT3 activity and induces cell death (apoptosis). In myeloproliferative disorders, mutations in JAK2 may play a role in allowing large numbers of abnormal blood cells or platelets to grow and spread in the bone marrow and the rest of the body. Based on its potential to inhibit this activity, lestaurtinib is in ongoing studies for the treatment of myeloproliferative disorders.
About Cephalon Oncology
Cephalon, a leading biopharmaceutical company, is building a diversified portfolio of oncology products that represents a comprehensive approach to extend and enhance the lives of patients with cancer. Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers.
