Ribozyme Pharmaceuticals, Inc. today announced that it has repurchased its rights to Heptazyme(TM) from Eli Lilly and Company and will initiate Phase II clinical trials as soon as possible for the Anti-Hepatitis C ribozyme to study dose-ranging and biological markers of the drug’s efficacy in chronic Hepatitis C patients.
Earlier this month, RPI and Eli Lilly and Company completed a 28 day study of Heptazyme (LY466700) following daily subcutaneous injections that showed successful safety, tolerability and pharmacokinetics. The next phase of clinical trials will examine the safety and efficacy of Heptazyme alone, at higher doses than used in previous studies, and in combination with interferon, a current treatment for patients with Hepatitis C virus infection.
Lilly has directed the clinical trials for the Anti-Hepatitis C ribozyme to date under a licensing agreement between the parties. Ribozyme Pharmaceuticals, Inc. has now renegotiated the global rights to Heptazyme and will direct all subsequent clinical trials. The Phase II trial is expected to begin in the first quarter of 2001.
“We are pleased to be able to repurchase Heptazyme rights and to have resources to develop it aggressively,” said Ralph E. Christoffersen, CEO and President of RPI. “We are committed to address the need for improved therapies for HCV, and plan to move forward as quickly as feasible in Heptazyme’s development.”
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.
RPI (www.rpi.com), located in Boulder, Colorado, is the acknowledged leader in ribozyme therapeutic development. RPI has recently announced a ribozyme commercial development program to develop a ribozyme therapeutic against Hepatitis B. RPI is partnered with Chiron Corporation for the development and commercialization of ANGIOZYME(TM), an anti-angiogenic ribozyme designed to inhibit the growth of new blood supplies to tumors and prevent tumor growth and metastasis. ANGIOZYME is in Phase I/II clinical trials in cancer patients at the Cleveland Clinic. RPI is also partnered with an affiliate of Elan Corporation plc for development and commercialization of HERZYME(TM), an anti-HER-2 ribozyme for treatment of breast and other cancers, through RPI’s subsidiary Medizyme Pharmaceuticals Ltd.
RPI will have a Live Webcast regarding this information today at 3:00 pm MDT. This webcast can be accessed through the RPI website (www.rpi.com) in the Investor Relations section.
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 RPI Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings.