To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Orphan Drug Designation To Bryostatin-1, In Combination With Taxol (Paclitaxel), For Esophageal Cancer URL: http://www.pslgroup.com/dg/20FF6A.htm Doctor's Guide December 12, 2001
MARTINSRIED/MUNICH, GERMANY and WALTHAM/BOSTON, MA -- December 12, 2001 -- GPC Biotech AG, a leading genomics- and proteomics-driven drug discovery and development company, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation for its Phase II clinical compound Bryostatin-1 in combination with Taxol (paclitaxel) for the treatment of esophageal cancer. The orphan drug designation allows GPC Biotech exclusive marketing rights for the esophageal cancer indication in the US on Bryostatin-1 for seven years following marketing approval by the FDA. The designation also enables GPC Biotech to apply for research funding, tax credits on certain research expenses and a waiver from the FDA's application user fee. Preliminary results from a current Phase II study at Memorial Sloan Kettering Cancer Center suggest that Bryostatin-1 increases tumor response when used in combination with Taxol against esophageal cancer. GPC Biotech plans to advance Bryostatin-1 through Phase III clinical studies in combination with Taxol for the treatment of esophageal cancer as well as other clinical trials in additional indications if the clinical results continue to be positive. In addition to the clinical trials for esophageal cancer, Bryostatin-1 is currently in a number of additional Phase II human clinical trials in combination with other therapeutics for several different indications. Bryostatin-1 is linked to the modulation of Protein Kinase C (PKC), a well-validated anti-cancer target. PKC is an attractive target for cancer chemotherapy as this kinase family plays a fundamental role in the development of cancer through regulating cell growth and programmed cell death (apoptosis). Esophageal cancer is a devastating disease with a tremendous unmet medical need. The FDA's orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 US residents. SOURCE: GPC Biotech AG --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.