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References<\/strong> <\/p>\r\n

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About tecemotide<\/strong> <\/p>\r\n
Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy that is designed to stimulate the body's immune system to identify and target cells expressing the cell-surface glycoprotein MUC1. MUC1 is expressed in many cancers, including non-small cell lung cancer (NSCLC), and has multiple roles in tumor growth and survival. Tecemotide is currently being investigated in the Phase III START2, START and INSPIRE trials for the treatment of unresectable, locally advanced Stage III NSCLC.<\/p>\r\n
Merck obtained the exclusive worldwide rights for development and commercialization of tecemotide from Oncothyreon Inc., Seattle, Washington, U.S., in 2007, in an agreement replacing prior collaboration and supply agreements originally entered in 2001. In Japan, Merck entered into a co-development and co-marketing agreement for tecemotide with Ono Pharmaceutical Co., Ltd., Osaka, Japan.<\/p>\r\n
The START2 trial is a Phase III, multicenter, 1:1 randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT). The primary endpoint of START2 trial is overall survival.<\/p>\r\n
The initial Phase III trial START is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy (concurrent or sequential). The trial involves 1,239 patients in 33 countries. The primary endpoint of overall survival was not met in the START trial.<\/p>\r\n
INSPIRE (tecemotide liposome vaccine trial I<\/strong>n Asian NS<\/strong>CLC P<\/strong>atients: Stimulating I<\/strong>mmune RE<\/strong>sponse) is a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced Stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy. INSPIRE is recruiting approximately 500 unresectable, locally advanced Stage III NSCLC patients across mainland China, Hong Kong, Korea, Singapore and Taiwan.<\/p>\r\n
Tecemotide is currently under clinical investigation and has not been approved for use in the U.S., Europe, Canada, or elsewhere. Tecemotide has not been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.<\/p>\r\n
About Merck Serono<\/strong> <\/p>\r\n
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.<\/p>\r\n
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.<\/p>\r\n
For more information, please visit http:\/\/www.merckserono.com<\/a>.<\/p>\r\n
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http:\/\/www.merckgroup.com\/subscribe<\/a> to register online, change your selection or discontinue this service.<\/p>\r\n
Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of EUR 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.<\/p>\r\n
Merck is the world's oldest pharmaceutical company - since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day.<\/p>\r\n
Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.<\/p>"]; $("#dvExtra").html(content_array[0]);})();