AnGes MG, Vical to Start Phase III Clinical Trial of Allovectin for Gene Therapy.Tokyo, Japan, Jan 10, 2007 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) ) - AnGes MG Inc. and the U.S. based Vical Inc. (Vical) today announced the start of phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA of their clinical trial of Allovectin-7 -a gene therapy treatment drug for progressive melanoma melanoma: see skin cancer. melanoma Dark-coloured malignant tumour of skin cells that produce the protective skin-darkening pigment melanin. patients. Allovectin was assigned as an orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the , and is aiming to monopolize mo·nop·o·lize tr.v. mo·nop·o·lized, mo·nop·o·liz·ing, mo·nop·o·liz·es 1. To acquire or maintain a monopoly of. 2. To dominate by excluding others: monopolized the conversation. the market after its sales and distribution have been approved. The patients in the clinical trial are in their third or fourth stage of recurring progressive melanoma and had not been treated with chemotherapy previously. 375 patients are taking part, 250 of them were given Allovectin-7 while the remaining 125 (the control group) were given decarbazine or temozolomide. The General Manager and Vice President of Vical Robin M.Jackman said, "We are delighted to begin the comparative trial of Allovectin-7 and the conventional drug. We have not had any new drugs for the past 15 years and so Allovectin-7 is a long-awaited drug. With the durable response rate at 6 months, we can look forward to the fast expedition of the drug on the market." Copyright [c] 2007 Japan Corporate News Network. All rights reserved. |
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