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Coley Pharmaceutical Group's Vaccine Adjuvant, VaxImmune, to Enter Phase III Clinical Testing as Part of GlaxoSmithKline's Novel Cancer Immunotherapeutic in Non-Small Cell Lung Cancer
2007 JUN 18 -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) announced that its vaccine adjuvant, VaxImmune(TM), will be evaluated in a Phase III clinical trial as part of GlaxoSmithKline's (GSK) MAGE-A3 cancer immunotherapeutic in patients with early stage, completely resected non-small cell lung cancer (stage IB, II or IIIA NSCLC). This will be Coley's second Toll-like receptor 9 (TLR9) agonist drug candidate to be studied in Phase III clinical trials for the treatment of NSCLC. GSK's Phase III trial will evaluate MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. MAGE-A3 is a tumor-specific antigen that is expressed in a variety of cancers, including NSCLC, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities. GSK's ASCI represents a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary Adjuvant Systems which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. VaxImmune is one of the components of the GSK proprietary Adjuvant System which will be used in the MAGE-A3 ASCI evaluated in the Phase III trial. VaxImmune is a proprietary TLR9 agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response to vaccines against infectious diseases or cancer in order to achieve and sustain a clinical response without compromising safety. Coley has granted GSK worldwide licenses for the use of VaxImmune in GSK's vaccines in development for certain cancers and infectious diseases. The GSK Phase III clinical trial which was announced will target enrollment of about 2,270 patients. The randomized, double-blind, and placebo- controlled MAGRIT trial (MAGE-A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy) will enroll patients with stage IB, II or IIIA resectable NSCLC. The MAGE-A3 ASCI administration will be initiated in two groups of patients: after surgery and standard chemotherapy in one group of patients and after surgery in patients who are not receiving chemotherapy. The primary endpoint of the trial is disease-free survival. The initiation of this Phase III clinical trial will trigger a milestone payment to Coley. Keywords: Biological Therapy, Biotechnology, Cancer Vaccines, Clinical Trial Research, Coley Pharmaceutical Group, Drug Development, GlaxoSmithKline, Immunotherapy, Infectious Disease, Lung Neoplasms, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Oncology, Pharmaceutical Business, Pharmaceutical Company, Pharmaceuticals, Pulmonology, Respiratory Infection, Treatment, Cancer Vaccine, Coley Pharmaceutical Group Inc. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.
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