Maxim Pharmaceuticals announced that the Data Safety Monitoring Board (DSMB) responsible for reviewing its Phase 2 trial of Ceplene (histamine dihydrochloride) for the treatment of hepatitis C nonresponder patients has concluded that there have been no safety concerns associated with the triple-drug combination of Ceplene, Peg-Intron (peginterferon alfa-2b) and Rebetol (ribavirin, USP).

The randomized, controlled Phase 2 study is designed to compare the treatment of nonresponder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron and Rebetol versus treatment with Peg-Intron and Rebetol combination therapy alone. The study will include up to 282 patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin. The DSMB reported to Maxim that it has reviewed the safety data through 12 weeks of treatment for the first 41 patients enrolled in the trial, and has concluded that there have been no safety concerns and that the trial should proceed under its approved protocol.

The DSMB includes world-leading clinicians experienced in the treatment of hepatitis C who review the safety data from this Phase 2 clinical trial on an ongoing basis. Maxim is conducting the Phase 2 trial under an agreement whereby Schering Corp., a division of Schering-Plough Corp., is contributing two of its products, Peg-Intron and Rebetol, and performing the viral testing for the study.

The Maxim Phase 2 trial is designed to evaluate the Ceplene triple-drug combination therapy for the treatment of nonresponder patients infected with hepatitis C who failed to respond to prior therapy. Patients will be treated for up to 48 weeks and followed for an additional 24 weeks after completion of treatment. The primary measures of efficacy in the study are sustained complete viral response and sustained biochemical response (normalization of the liver enzyme ALT, a standard measure of liver function) at 72 weeks. The trial is being conducted in Western Europe and Israel.

Hepatitis C is 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 at least 200 million people are infected worldwide. Hepatitis C is a viral infection in which oxidative stress causes inflammation and tissue damage in the liver and, in many cases, permanent cirrhosis (scarring). The cycle 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.

The standard treatment for hepatitis C is interferon-alpha, an immunotherapeutic agent given in combination with the anti-viral drug ribavirin. The most recent advance in hepatitis C therapy approved for sale is a pegylated, or sustained release, formulation of interferon-alpha given in combination with ribavirin. Even with recent advances, approximately half of patients still do not attain a sustained response with current therapies.