SLOAN CANCER VACCINE PHASE III STUDY BEGINS.Merck KGaA, Darmstadt, Germany, has announced that the first patient has been enrolled in its global Phase III clinical study, START (Stimulating Targeted Antigenic Responses To NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there ), assessing the efficacy and safety of Stimuvax (BLP BLP Barbados Labour Party BLP Bible Literacy Project BLP Bypass Label Processing (IBM) BLP Buddhist Liberal Party (Cambodia) BLP Bonded Logistics Park BLP Borland Learning Partner 25 liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. vaccine) as a potential treatment for patients with unresectable stage III non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. (NSCLC). Enrollment in the study, which will involve more than 1,300 patients in approximately 30 countries, is now open to patients in the U.S. where the first randomization randomization (ranˈ·d  ·m has occurred. Enrollment will
subsequently expand to additional countries. Currently, there are no
approved maintenance therapies for patients responding to first-line
treatment for unresectable stage III NSCLC.
"Patients with advanced lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. are in need of new therapies that effectively target cancer cells while providing better safety and tolerability," said Dr. Frances Shepherd, Director of Medical Oncology at Princess Margaret Hospital There are several Princess Margaret Hospitals :
Lung cancer is the leading cause of cancer-related deaths in both men and women worldwide with approximately 80 percent of cases classified as NSCLC. Further, only about 15 percent of people diagnosed with NSCLC survive this disease after five years.1 For most patients with NSCLC, current treatments provide limited success. "The START study is the first Phase III program to evaluate a cancer vaccine in unresectable stage III non-small cell lung cancer and marks an important milestone for the company in its growing oncology business," said Dr. Wolfgang Wein, senior executive vice president, Oncology, Merck Serono. "Our continued investment in research reflects our confidence in Stimuvax and commitment to developing innovative targeted therapies to advance treatment options for patients with cancer." The START study is a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) through a Special Protocol Assessment (SPA). Data from a randomized phase IIb study encouraged the initiation of the Phase III program. For more information on the START study, or to find a participating center and eligibility criteria, go to http://www.nsclcstudy.com. The study is also listed on http://www.clinicaltrials.gov. About Stimuvax Stimuvax is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC MUC Mount Union College (Ohio) MUC Multi User Chat MUC Message Understanding Conference MUC Montreal Urban Community MUC Malaspina University College (Canada) 1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1. A randomized Phase IIb study was conducted in 171 patients with stage IIIb and IV NSCLC with response or stable disease after first line therapy. While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIb locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group - an improvement of 17.3 months. In the Phase IIb study, side effects were primarily limited to mild-to-moderate flu-like symptoms, GI disturbances, and mild injection site reactions. About Merck KGaA Merck KGaA is investigating the use of Stimuvax(r) (BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada where the companies will share rights. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD EMD Electromechanical dissociation, see there Serono Pharmaceuticals. For more information, call 212/845-5633. |
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