( THOUSAND OAKS Calif.--(BUSINESS WIRE)-...)Aranesp ``145 Study'' Shows No Difference in Survival in Patients,with Small-Cell Lung Cancer,Health

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Apr 19, 2007 - Amgen (NASDAQ: AMGN) today announced the results of the "145 study", a randomized, double-blind, placebo-controlled, multicenter Phase 3 study of Aranesp(R) (darbepoetin alfa) in 600 previously untreated patients with extensive-stage small-cell lung cancer (SCLC) receiving platinum-containing chemotherapy. The study demonstrated no statistically significant difference in risk of death (overall survival Aranesp compared to placebo Hazard Ratio (HR): 0.93, 95% CI: 0.78 to 1.11) or investigator determined progression-free survival (HR: 1.02, 95% CI: 0.86 to 1.21).

The study demonstrated a significant change in hemoglobin concentration from baseline in favor of Aranesp (a co-primary endpoint). Aranesp-treated patients also experienced a significantly lower risk of blood transfusions (HR: 0.40, 95% CI: 0.29 to 0.55). The overall safety profile, including thromboembolic events, was consistent with that described in the U.S. label.

"The 145 study is a component of Amgen's ongoing pharmacovigilance program designed to evaluate the effect of Aranesp on long-term survival in patients with chemotherapy-induced anemia. This study had higher initiation and maintenance hemoglobin targets (Hb less than or equal to 13 g/dl) than in the U.S. label," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "These results contribute to the growing body of evidence on ESA safety, reinforcing the neutral impact of ESAs on survival in cancer patients suffering from chemotherapy-induced anemia."

Amgen initiated the SCLC study in 2002 after results from a previous Phase 3 study showed a trend towards improved survival in patients with lung cancer. The 145 study was designed to evaluate whether increasing or maintaining hemoglobin concentrations with Aranesp, when administered with platinum-containing chemotherapy in patien
'"/>

Page: 1 2 3 4 5 6 7
Related medicine technology :

1. Aranesp Phase 3 Study in Patients with Active Cancer Not Receiving Concurrent Chemotherapy or Radiotherapy Presented at AACR Annual Meeting
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
4. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
5. MediGene Announces Cancer-Fighting Virus Shows Promise in Early Clinical Trial
6. Study Shows Ixabepilone Demonstrated Clear Activity in Patients with Metastatic Breast Cancer Resistant to Anthracycline, Taxane, and Capecitabine
7. Ceragenix Compound Shows Promise for Treating Lethal Cystic Fibrosis Infections
8. Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix Provides Excellent Protection Against Lesions Caused by Most Common Cancer-Causing Virus Types
9. CombinatoRx Product Candidate CRx-150 Shows Activity on DAS28 and Pain, but Not CRP
10. New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir
11. First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes