To: bob zagorin who wrote (297 ) 1/11/2000 11:24:00 AM From: bob zagorin Read Replies (1) | Respond to of 562
Antihepatitis C Ribozyme IND Filed by Lilly and RPI INDIANAPOLIS, Jan. 11 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Ribozyme Pharmaceuticals, Inc. (RPI) (Nasdaq: RZYM), announced today that an Investigational New Drug Application (IND) has been submitted to the U.S. Food and Drug Administration (FDA) to begin clinical testing of RPI's antihepatitis C ribozyme, LY466700 (previously referred to as "Heptazyme"). If the Food and Drug Administration approves the IND, the initial clinical study will consist of a safety and pharmacokinetic study in normal volunteers followed by a second study in hepatitis-C-infected, treatment-naive patients. The second study will be a multidose clinical study designed to examine safety, pharmacokinetics and the extent of HCV RNA reduction in the blood. LY466700 is a chemically synthesized ribozyme that is designed to selectively cut hepatitis C virus (HCV) RNA and inhibit viral replication. It is expected to be effective against all known HCV genotypes since it targets a conserved region of HCV RNA, and is also expected to be effective even after infection or replication has been established. HCV is the most common chronic bloodborne infection in the U.S. and is considered an epidemic by the Centers for Disease Control with a four-fold higher prevalence than HIV. More than 4 million people are infected in the U.S. and 125 million people are reported to be infected worldwide. Chronic infection can lead to liver inflammation, cirrhosis, cancer and death. Current treatment options for patients are limited, clearing virus in only 20 percent to 40 percent of patients, and can be associated with some serious side effects. "We are pleased with the progress made to date in our collaboration and are looking forward to being able to move forward into human studies with this potentially exciting product," said Gail H. Cassell, Ph.D., vice president of infectious diseases discovery research and clinical investigation for Lilly. "There clearly are unmet medical needs for effective management of hepatitis C viral disease in the United States and throughout the rest of the world." "Since HCV remains such a serious disease with limited treatment options, we are very pleased that our Lilly collaboration has resulted in rapid IND filing following initiation of the collaboration in March, 1999," said Ralph E. Christoffersen, Ph.D., chief executive officer and president of RPI. "The preclinical results appear quite promising, and we look forward to initiating clinical trials with this anti-HCV ribozyme." Ribozymes are the product of Nobel Prize winning science and are synthetically engineered to act as "molecular scissors" capable of cleaving target RNA in a highly specific manner. Preclinical studies presented recently at the American Association for the Study of Liver Disease conference demonstrated specific inhibition of chimeric HCV-poliovirus replication in cell culture with a ribozyme mechanism of action. In addition, uptake in liver cells in mice was shown following either subcutaneous or intravenous administration. LY466700 has also shown an enhanced effect when combined with interferon in cell culture studies. Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions which enable people to live longer, healthier and more active lives. RPI, located in Boulder, Colorado, is the acknowledged leader in ribozyme therapeutic development. In addition to its collaboration with Lilly for development of an anti-HCV ribozyme, RPI is partnered with Chiron Corporation for the development and commercialization of ANGIOZYME(TM), an antiangiogenic ribozyme designed to inhibit the growth of new blood supplies to tumors and prevent tumor growth and metastasis. RPI is also partnered with Elan Corporation for development and commercialization of HEKZYME(TM), an anti-her2 ribozyme for treatment of breast and other cancers. This press release contains forward-looking statements that involve risks and uncertainties, and actual events or results may differ materially. These risk factors include actions by the U.S. Food and Drug Administration, technological advances, ability to obtain rights to technology, ability to obtain and enforce patents, ability to commercialize and manufacture products and general economic conditions. These and additional risk factors are identified in Lilly and RPI Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings. SOURCE Eli Lilly and Company CO: Eli Lilly and Company; Ribozyme Pharmaceuticals, Inc. ST: Indiana, Colorado IN: MTC SU: 01/11/2000 08:01 EST prnewswire.com