ACT Biotech Receives Orphan Drug Designation for Telatinib, an Orally Available and Highly Selective Kinase Inhibitor, in Gastric Cancer
Published: Jun 02, 2010
SAN FRANCISCO--(BUSINESS WIRE)--ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, announced today that the company’s highly selective oral kinase inhibitor, Telatinib, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer. Telatinib is currently in Phase 2 clinical testing in the United States and in Europe for the first-line treatment of advanced gastric cancer patients in combination with standard-of-care chemotherapy. The company is preparing Telatinib to be Phase 3 ready for first-line gastric cancer treatment by the end of 2010, with New Drug Application (NDA) filing targeted for 2013.