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FDA Grants Orphan Drug Designation To Bryostatin-1, In Combination With Taxol (Paclitaxel), For Esophageal Cancer 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 E-mail this page to a friend or colleague! To print, use this version