MAXIM ANNOUNCES THAT CEPLENE™ WILL BE INCLUDED IN MULTI-NATIONAL STUDY OF INDIVIDUALIZED TREATMENT FOR HEPATITIS C
Maxim Pharmaceuticals (Nasdaq NM: MAXM, SSE: MAXM) today announced that Ceplene (histamine dihydrochloride) will be tested in a new multi-national clinical study, the "Dynamically Individualized Treatment of hepatitis C Infection and Correlates of Viral/Host Dynamics" study ("DITTO-HCV"), expected to commence this month. The overall objective of the study is to develop a new treatment strategy for chronic hepatitis C that can increase the sustained viral response to therapy, while minimizing impairment of quality of life and socio-economic burden. Sponsors of the study include the European Union Commission and F. Hoffmann - La Roche Ltd.
The DITTO-HCV study is expected to include up to 300 patients in nine clinical centers based in France, Germany, Greece, Italy, Israel, The Netherlands, Spain, Sweden and Switzerland. The objective of the study is to develop and evaluate treatment strategies tailored to the individual patient's response to initial therapy. The drugs to be evaluated in the study include pegylated interferon, ribavirin and Ceplene, in various doses and combinations. One of the arms of the study will test a triple-drug regimen of Ceplene in combination with pegylated interferon and ribavirin.
Maxim also announced that it expects that the 72-week data from its recently completed Phase 2 study of Ceplene in combination with interferon-alpha will be presented at the European Association for the Study of Liver (EASL) conference in Prague, Czech Republic on Friday, April 20, 2001.
Hepatitis C Overview
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries.
In early 2001 Maxim completed a 129-patient Phase 2 dose-ranging study of Ceplene in combination with IFN-a in the treatment of previously untreated hepatitis C-infected patients. The ongoing study was designed to evaluate the safety and activity of four different dose regimens of Ceplene in combination with interferon-alpha. In addition, the Company is conducting a pilot safety study to evaluate the feasibility and safety of triple-drug treatment with Ceplene in combination with IFN-a and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy or relapsed after prior therapy.
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